Trial Outcomes & Findings for A Safety and Immunogenicity of Intranasal Nanoemulsion Adjuvanted Recombinant Pandemic Flu Vaccine in Healthy Adults (NCT NCT05397119)
NCT ID: NCT05397119
Last Updated: 2026-07-30
Results Overview
Local and systemic reactions will be assessed in the clinic within 1 hour of intranasal BW-1014, positive control, and placebo administration, including visual assessment of nasal passages
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
Within one hour of first intranasal vaccination
Results posted on
2026-07-30
Participant Flow
Participant milestones
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
A Safety and Immunogenicity of Intranasal Nanoemulsion Adjuvanted Recombinant Pandemic Flu Vaccine in Healthy Adults
Baseline characteristics by cohort
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
n=8 Participants
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
n=8 Participants
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=9 Participants
|
40 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=9 Participants
|
18 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=9 Participants
|
22 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
6 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=9 Participants
|
34 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=9 Participants
|
7 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
8 Participants
n=5 Participants
|
5 Participants
n=9 Participants
|
28 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Within one hour of first intranasal vaccinationPopulation: The analysis population includes all participants who received study vaccination and for whom data were available at any particular timepoint
Local and systemic reactions will be assessed in the clinic within 1 hour of intranasal BW-1014, positive control, and placebo administration, including visual assessment of nasal passages
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
n=8 Participants
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
n=8 Participants
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Safety Outcome: Number of Participants Reporting Local or Systemic Reactions After First Intranasal Vaccination
|
8 Participants
|
7 Participants
|
8 Participants
|
3 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 7 daysPopulation: The analysis population includes all participants who received study vaccination and for whom data were available at any particular timepoint
Solicited reactions and general AEs will be assessed in follow up visit/phone call within 7 days of first intranasal vaccination with intranasal BW-1014, positive control and placebo
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
n=8 Participants
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
n=8 Participants
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Safety Outcome: Number of Participants Reporting Solicited Reactions and General AEs After First Intranasal Vaccination
|
8 Participants
|
7 Participants
|
8 Participants
|
5 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Day 29 and Day 57 (each summarizing unsolicited adverse events occurring during the preceding 28-day period)Population: The analysis population includes all participants who received study vaccination and for whom data were available at any particular timepoint
Number and proportion of participants reporting unsolicited adverse events within 28 days after each intranasal vaccination with BW-1014, rH5 control, or placebo, assessed at study Days 29 and 57.
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
n=8 Participants
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
n=8 Participants
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Safety Objective: Number of Participants Reporting Unsolicited AEs
|
3 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 7 daysPopulation: The analysis population includes all participants who received study vaccination and for whom data were available at any particular timepoint
Hematological and biochemical laboratory abnormalities (Grade 1 or higher) were assessed in follow-up visits within 7 days after the first intranasal vaccination with BW-1014, rH5 control, or placebo using protocol-specified hematology and clinical chemistry laboratory evaluations
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
n=8 Participants
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
n=8 Participants
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Safety Outcome: Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormality (Grade 1 of Higher) Within 7 Days of the First Intranasal Vaccination
|
6 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 57 daysPopulation: The analysis population includes all participants who received study vaccination and for whom data were available at any particular timepoint
MAAEs will be assessed in follow up visits/phone calls within 28 days of primary vaccinations with intranasal BW-1014, positive control, and placebo
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
n=8 Participants
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
n=8 Participants
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Safety Outcome: Number of Participants Reporting Medically Attended AEs (MAAEs)
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 393Population: The analysis population includes all participants who received study vaccination and for whom data were available at any particular timepoint
SAEs will be assessed by study arm. An adverse event is considered "serious" if it results in death, or a life-threatening AE, or in hospitalization, or in a substantial disruption of the ability to conduct normal life functions, or in a congenital anomaly/birth defect.
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
n=8 Participants
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
n=8 Participants
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Safety Outcome: Number of Participants Reporting Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 393Population: The analysis population includes all participants who received study vaccination and for whom data were available at any particular timepoint
PIMMCs will be assessed by follow up visits/phone calls following vaccinations with intranasal BW-1014, positive control, and placebo
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
n=8 Participants
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
n=8 Participants
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Safety Outcome: Number of Participants Reporting Potential Immune-mediated Medical Conditions (PIMMCs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 393Population: The analysis population includes all participants who received study vaccination and for whom data were available at any particular timepoint
NOCMCs will be assessed by follow up visits/phone calls following vaccinations with intranasal BW-1014, positive control, and placebo
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
n=8 Participants
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
n=8 Participants
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Safety Outcome: Number of Participants Reporting New Onset Chronic Medical Conditions (NOCMCs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within one hour of second intranasal vaccinationPopulation: The analysis population includes all participants who received study vaccination and for whom data were available at any particular timepoint
Local and systemic reactions will be assessed in the clinic within 1 hour of intranasal BW-1014, positive control, and placebo administration, including visual assessment of nasal passages
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
n=8 Participants
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
n=8 Participants
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Safety Outcome: Number of Participants Reporting Local or Systemic Reactions After Second Intranasal Vaccination
|
8 Participants
|
8 Participants
|
8 Participants
|
2 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Day 36, for the preceding 7-day periodPopulation: The analysis population includes all participants who received study vaccination and for whom data were available at any particular timepoint
Solicited reactions and general adverse events were assessed during follow-up visits and telephone contacts within 7 days after the second intranasal vaccination with BW-1014, rH5 control, or placebo
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
n=8 Participants
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
n=7 Participants
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Safety Outcome: Number of Participants Reporting Solicited Reactions and General AEs After Second Intranasal Vaccination
|
8 Participants
|
8 Participants
|
8 Participants
|
4 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Day 43, for the preceding 14-day periodPopulation: The analysis population includes all participants who received study vaccination and for whom data were available at any particular timepoint
Hematological and biochemical laboratory abnormalities (Grade 1 or higher) were assessed during follow-up visits within 14 days after the second intranasal vaccination with BW-1014, rH5 control, or placebo.
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
n=8 Participants
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
n=7 Participants
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Safety Outcome: Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormality (Grade 1 of Higher) Within 14 Days of the Second Intranasal Vaccination
|
5 Participants
|
3 Participants
|
6 Participants
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 197Population: The analysis population includes all participants who received study vaccination and for whom data were available at any particular timepoint
Number and percentage of participants experiencing local or systemic reactions within 1 hour of vaccination with intramuscular H5N1 IIV vaccine
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
n=7 Participants
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
n=6 Participants
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Safety Endpoint: Number of Participants Reporting Local or Systemic Reactions to Intramuscular H5N1 IIV Vaccine
|
1 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 204, for the preceding 7-day periodPopulation: The analysis population includes all participants who received study vaccination and for whom data were available at any particular timepoint
Solicited reactions and general adverse events were assessed within 7 days after intramuscular H5N1 IIV vaccination
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
n=7 Participants
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
n=6 Participants
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Safety Endpoint: Number of Participants Reporting Solicited Reactions and General AEs
|
4 Participants
|
5 Participants
|
7 Participants
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 225, for the preceding 28-day periodPopulation: The analysis population includes all participants who received study vaccination and for whom data were available at any particular timepoint
Unsolicited adverse events were assessed within 28 days after intramuscular H5N1 IIV vaccination
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
n=7 Participants
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
n=6 Participants
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Safety Endpoint: Number of Participants Reporting Unsolicited AEs
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 204, for the preceding 7-day periodPopulation: The analysis population includes all participants who received study vaccination and for whom data were available at any particular timepoint
Hematological and biochemical laboratory abnormalities (Grade 1 or higher) were assessed within 7 days after intramuscular H5N1 IIV vaccination.
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
n=7 Participants
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
n=6 Participants
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Safety Endpoint: Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormality (Grade 1 of Higher)
|
4 Participants
|
5 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 225, for the preceding 28-day periodPopulation: The analysis population includes all participants who received study vaccination and for whom data were available at any particular timepoint
Medically attended adverse events (MAAEs) were assessed within 28 days after intramuscular H5N1 IIV vaccination
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
n=7 Participants
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
n=6 Participants
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Safety Endpoint: Number of Participants Reporting Medically Attended AEs (MAAEs)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: The analysis population includes all participants who received study vaccination and for whom data were available at any particular timepoint
Serum H5N1 (clade 2.1) hemagglutination inhibition antibody geometric mean titers (GMTs) were measured in specimens collected on the day of, but prior to the first study vaccination (baseline)
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
n=8 Participants
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
n=8 Participants
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Primary Humoral Immune Response Outcome: Serum HI Geometrical Mean Titers Levels at Baseline
|
5.5 titer
Interval 4.4 to 6.7
|
5.0 titer
Interval 5.0 to 5.0
|
5.5 titer
Interval 4.4 to 6.7
|
5.0 titer
Interval 5.0 to 5.0
|
5.0 titer
Interval 5.0 to 5.0
|
SECONDARY outcome
Timeframe: Day 57 compared to Day 1Population: The analysis population includes all participants who received study vaccination and for whom data were available at any particular timepoint
Serum H5N1 (clade 2.1) hemagglutination inhibition antibody seroconversion rates were assessed 28 days after the second intranasal vaccination (study Day 57). Seroconversion was defined as a pre-vaccination HI titer \<1:10 with a post-vaccination HI titer ≥1:40, or a pre-vaccination HI titer ≥1:10 with a minimum four-fold rise in post-vaccination HI antibody titer.
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
n=8 Participants
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
n=6 Participants
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Primary Humoral Immune Response Outcome: Rates of Seroconversion
|
0.0 percentage of participants
Interval 0.0 to 36.9
|
0.0 percentage of participants
Interval 0.0 to 36.9
|
12.5 percentage of participants
Interval 0.3 to 52.7
|
0.0 percentage of participants
Interval 0.0 to 36.9
|
0.0 percentage of participants
Interval 0.0 to 45.9
|
SECONDARY outcome
Timeframe: BaselinePopulation: The analysis population includes all participants who received study vaccination and for whom data were available at any particular timepoint
Baseline strain-specific serum IgA geometric mean titer (GMT) was measured by ELISA in specimens collected on the day of, but prior to, the first study vaccination
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
n=8 Participants
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
n=8 Participants
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Primary Humoral Immune Response Outcome: Serum IgA ELISA Geometric Mean Titer (GMT) at Baseline
|
138.3 titer
Interval 67.3 to 284.1
|
167.8 titer
Interval 53.3 to 527.9
|
118.6 titer
Interval 41.4 to 340.2
|
177.9 titer
Interval 62.6 to 505.3
|
128.1 titer
Interval 66.9 to 245.2
|
SECONDARY outcome
Timeframe: baselinePopulation: The analysis population includes all participants who received study vaccination and for whom data were available at any particular timepoint
Mucosal vaccine-specific IgA geometric mean titer (GMT) was measured by ELISA in nasal lavage specimens collected on the day of, but prior to, the first study vaccination
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
n=8 Participants
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
n=8 Participants
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IgA Geometric Mean Titer (GMT) at Baseline
|
4.8 titer
Interval 1.8 to 12.8
|
4.2 titer
Interval 1.3 to 13.9
|
2.1 titer
Interval 0.9 to 4.9
|
5.1 titer
Interval 2.3 to 11.2
|
4.2 titer
Interval 2.0 to 8.8
|
SECONDARY outcome
Timeframe: Up to Day 197Population: Nasal lavage specimens were collected according to protocol. However, insufficient numbers of viable cells were recovered from the specimens to perform the prespecified flow cytometry assays. Because the assays could not be performed, no analyzable data were generated for this outcome measure and no participants were included in the analysis
Vaccine-specific activation marker (CD69) expression was assessed by flow cytometry in cells isolated from nasal lavage specimens collected through study Day 197 following intranasal vaccination
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific Activation Marker (CD69), Cytokines/Chemokines
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 197Population: Nasal lavage specimens were collected according to protocol. However, insufficient numbers of viable cells were recovered from the specimens to perform the prespecified flow cytometry assays. Because the assays could not be performed, no analyzable data were generated for this outcome measure and no participants were included in the analysis
Vaccine-specific activation marker (CD154) expression was assessed by flow cytometry in cells isolated from nasal lavage specimens collected through study Day 197 following intranasal vaccination
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific Activation Marker (CD154), Cytokines/Chemokines
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: baselinePopulation: The analysis population includes all participants who received study vaccination and for whom data were available at any particular timepoint
Mucosal vaccine-specific IgG geometric mean titer (GMT) was measured by ELISA in nasal lavage specimens collected on the day of, but prior to, the first study vaccination
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
n=8 Participants
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
n=8 Participants
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IgG Geometric Mean Titer (GMT) at Baseline
|
2.0 titer
Interval 1.0 to 4.2
|
1.5 titer
Interval 0.6 to 3.7
|
1.0 titer
Interval 0.6 to 1.8
|
1.4 titer
Interval 0.7 to 2.9
|
1.5 titer
Interval 0.7 to 3.5
|
SECONDARY outcome
Timeframe: Up to Day 197Population: Nasal lavage specimens were collected according to protocol. However, insufficient numbers of viable cells were recovered from the specimens to perform the prespecified flow cytometry assays. Because the assays could not be performed, no analyzable data were generated for this outcome measure and no participants were included in the analysis
Vaccine-specific TNF-α expression was assessed by flow cytometry in cells isolated from nasal lavage specimens collected through study Day 197 following intranasal vaccination
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IFN-gamma
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Up to Day 197Population: Nasal lavage specimens were collected according to protocol. However, insufficient numbers of viable cells were recovered from the specimens to perform the prespecified flow cytometry assays. Because the assays could not be performed, no analyzable data were generated for this outcome measure and no participants were included in the analysis
Vaccine-specific cytokine (TNF-α) expression was assessed by flow cytometry in cells isolated from nasal lavage specimens collected through study Day 197 following intranasal vaccination
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific TNF-α
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 197Population: Nasal lavage specimens were collected according to protocol. However, insufficient numbers of viable cells were recovered from the specimens to perform the prespecified flow cytometry assays. Because the assays could not be performed, no analyzable data were generated for this outcome measure and no participants were included in the analysis
Vaccine-specific IL-4 expression was assessed by flow cytometry in cells isolated from nasal lavage specimens collected through study Day 197 following intranasal vaccination
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IL-4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 197Population: Nasal lavage specimens were collected according to protocol. However, insufficient numbers of viable cells were recovered from the specimens to perform the prespecified flow cytometry assays. Because the assays could not be performed, no analyzable data were generated for this outcome measure and no participants were included in the analysis
Vaccine-specific cytokine (IL-2) expression was assessed by flow cytometry in cells isolated from nasal lavage specimens collected through study Day 197 following intranasal vaccination
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IL-2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 197Population: Nasal lavage specimens were collected according to protocol. However, insufficient numbers of viable cells were recovered from the specimens to perform the prespecified flow cytometry assays. Because the assays could not be performed, no analyzable data were generated for this outcome measure and no participants were included in the analysis
Vaccine-specific IL-10 expression was assessed by flow cytometry in cells isolated from nasal lavage specimens collected through study Day 197 following intranasal vaccination
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IL-10
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 197Population: Nasal lavage specimens were collected according to protocol. However, insufficient numbers of viable cells were recovered from the specimens to perform the prespecified flow cytometry assays. Because the assays could not be performed, no analyzable data were generated for this outcome measure and no participants were included in the analysis
Vaccine-specific IL-21 expression was assessed by flow cytometry in cells isolated from nasal lavage specimens collected through study Day 197 following intranasal vaccination
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IL-21
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 197Population: Nasal lavage specimens were collected according to protocol. However, insufficient numbers of viable cells were recovered from the specimens to perform the prespecified flow cytometry assays. Because the assays could not be performed, no analyzable data were generated for this outcome measure and no participants were included in the analysis
Vaccine-specific degranulation marker (CD107a) expression was assessed by flow cytometry in cells isolated from nasal lavage specimens collected through study Day 197 following intranasal vaccination
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific CD107a
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 197Population: Nasal lavage specimens were collected according to protocol. However, insufficient numbers of viable cells were recovered from the specimens to perform the prespecified flow cytometry assays. Because the assays could not be performed, no analyzable data were generated for this outcome measure and no participants were included in the analysis
Vaccine-specific degranulation marker (Granzyme B) expression was assessed by flow cytometry in cells isolated from nasal lavage specimens collected through study Day 197 following intranasal vaccination
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific Granzyme B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 197Population: Nasal lavage specimens were collected according to protocol. However, insufficient numbers of viable cells were recovered from the specimens to perform the prespecified flow cytometry assays. Because the assays could not be performed, no analyzable data were generated for this outcome measure and no participants were included in the analysis
Vaccine-specific effector memory T-cell subsets were assessed by flow cytometry in cells isolated from nasal lavage specimens collected through study Day 197 following intranasal vaccination
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific T-cell Memory Subset (Effector Memory Cell)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 197Population: Nasal lavage specimens were collected according to protocol. However, insufficient numbers of viable cells were recovered from the specimens to perform the prespecified flow cytometry assays. Because the assays could not be performed, no analyzable data were generated for this outcome measure and no participants were included in the analysis
Vaccine-specific T-cell memory subset (central memory cell) expression was assessed by flow cytometry in cells isolated from nasal lavage specimens collected through study Day 197 following intranasal vaccination
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific T-cell Memory Subset (Central Memory Cell)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 197Population: Nasal lavage specimens were collected according to protocol. However, insufficient numbers of viable cells were recovered from the specimens to perform the prespecified flow cytometry assays. Because the assays could not be performed, no analyzable data were generated for this outcome measure and no participants were included in the analysis
Vaccine-specific T-cell memory subset (effector memory CD45RA+ cell) expression was assessed by flow cytometry in cells isolated from nasal lavage specimens collected through study Day 197 following intranasal vaccination
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific T-cell Memory Subset (Effector Memory CD45RA+ Cell)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 57Population: The analysis population includes all participants who received study vaccination and for whom data were available at any particular timepoint
Serum H5N1 (clade 2.1) hemagglutination inhibition geometric mean titer (GMT) was assessed in specimens collected 28 days after the second intranasal vaccination (study Day 57)
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
n=8 Participants
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
n=6 Participants
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Primary Humoral Immune Response Outcome: Serum H5N1 (Clade 2.1) Hemagglutination Inhibition Geometric Mean Titer (GMT) at Day 57
|
5.5 titer
Interval 4.4 to 6.7
|
5.5 titer
Interval 4.4 to 6.7
|
8.4 titer
Interval 3.8 to 18.8
|
5.0 titer
Interval 5.0 to 5.0
|
5.0 titer
Interval 5.0 to 5.0
|
SECONDARY outcome
Timeframe: Day 57Population: The analysis population includes all participants who received study vaccination and for whom data were available at any particular timepoint
Strain-specific serum IgA geometric mean titer (GMT) was measured by ELISA in specimens collected 28 days after the second intranasal vaccination (study Day 57)
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
n=8 Participants
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
n=6 Participants
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Primary Humoral Immune Response Outcome: Serum IgA ELISA Geometric Mean Titer (GMT) After Both Intranasal Vaccinations
|
2197.7 titer
Interval 681.3 to 7088.8
|
1476.2 titer
Interval 367.6 to 5928.3
|
1204.2 titer
Interval 602.4 to 2406.9
|
245.3 titer
Interval 93.8 to 641.3
|
123.3 titer
Interval 58.7 to 258.8
|
SECONDARY outcome
Timeframe: BaselinePopulation: The analysis population includes all participants who received study vaccination and for whom data were available at any particular timepoint
Baseline strain-specific serum IgG geometric mean titer (GMT) was measured by ELISA in specimens collected on the day of, but before, the first study vaccination
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
n=8 Participants
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
n=8 Participants
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Primary Humoral Immune Response Outcome: Serum IgG ELISA Geometric Mean Titer (GMT) at Baseline
|
9122.5 titer
Interval 5191.7 to 16029.4
|
8163.3 titer
Interval 3556.4 to 18737.8
|
6216.6 titer
Interval 2780.3 to 13900.2
|
8630.2 titer
Interval 5323.9 to 13989.7
|
3901.5 titer
Interval 1763.9 to 8629.5
|
SECONDARY outcome
Timeframe: Day 57Population: The analysis population includes all participants who received study vaccination and for whom data were available at any particular timepoint
Strain-specific serum IgG geometric mean titer (GMT) was measured by ELISA in specimens collected 28 days after the second intranasal vaccination (study Day 57).
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
n=8 Participants
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
n=6 Participants
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Primary Humoral Immune Response Outcome: Serum IgG ELISA Geometric Mean Titer (GMT) at Day 57
|
49976.0 titer
Interval 32392.7 to 77105.0
|
39017.0 titer
Interval 27607.0 to 55143.9
|
38849.0 titer
Interval 18416.5 to 81952.1
|
7842.8 titer
Interval 4661.2 to 13196.0
|
3460.8 titer
Interval 1247.4 to 9601.8
|
SECONDARY outcome
Timeframe: Day 43Population: The analysis population includes all participants who received study vaccination and for whom data were available at any particular timepoint
Mucosal vaccine-specific IgG geometric mean titer (GMT) was measured by ELISA in nasal lavage specimens collected 14 days after the second intranasal vaccination (study Day 43)
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
n=7 Participants
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
n=6 Participants
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IgG Geometric Mean Titer (GMT) at Day 43
|
25.6 titer
Interval 10.5 to 62.2
|
8.9 titer
Interval 5.0 to 15.7
|
5.7 titer
Interval 1.7 to 19.1
|
1.1 titer
Interval 0.6 to 2.1
|
1.1 titer
Interval 0.4 to 2.6
|
SECONDARY outcome
Timeframe: Day 57Population: The analysis population includes all participants who received study vaccination and for whom data were available at any particular timepoint
Mucosal vaccine-specific IgG geometric mean titer (GMT) was measured by ELISA in nasal lavage specimens collected 28 days after the second intranasal vaccination (study Day 57)
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
n=8 Participants
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
n=6 Participants
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IgG Geometric Mean Titer (GMT) at Day 57
|
13.0 titer
Interval 6.5 to 26.3
|
9.8 titer
Interval 4.6 to 21.0
|
4.3 titer
Interval 1.6 to 11.3
|
1.6 titer
Interval 0.8 to 3.5
|
1.1 titer
Interval 0.4 to 2.9
|
SECONDARY outcome
Timeframe: Day 197Population: The analysis population includes all participants who received study vaccination and for whom data were available at any particular timepoint
Mucosal vaccine-specific IgG geometric mean titer (GMT) was measured by ELISA in nasal lavage specimens collected immediately before intramuscular H5N1 IIV vaccination (study Day 197)
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
n=7 Participants
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
n=6 Participants
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IgG Geometric Mean Titer (GMT) at Day 197
|
8.6 titer
Interval 4.6 to 16.0
|
7.9 titer
Interval 4.2 to 14.8
|
3.8 titer
Interval 1.4 to 10.3
|
2.4 titer
Interval 1.0 to 5.9
|
2.0 titer
Interval 0.4 to 10.6
|
SECONDARY outcome
Timeframe: Day 43Population: The analysis population includes all participants who received study vaccination and for whom data were available at any particular timepoint
Mucosal vaccine-specific IgA geometric mean titer (GMT) was measured by ELISA in nasal lavage specimens collected 14 days after the second intranasal vaccination (study Day 43)
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
n=7 Participants
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
n=6 Participants
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IgA Geometric Mean Titer (GMT) at Day 43
|
28.6 titer
Interval 11.3 to 72.0
|
18.0 titer
Interval 6.1 to 53.4
|
11.1 titer
Interval 5.6 to 22.2
|
3.1 titer
Interval 1.0 to 9.9
|
3.8 titer
Interval 1.0 to 14.6
|
SECONDARY outcome
Timeframe: Day 57Population: The analysis population includes all participants who received study vaccination and for whom data were available at any particular timepoint
Mucosal vaccine-specific IgA geometric mean titer (GMT) was measured by ELISA in nasal lavage specimens collected 28 days after the second intranasal vaccination (study Day 57)
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
n=8 Participants
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
n=6 Participants
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IgA Geometric Mean Titer (GMT) at Day 57
|
25.2 titer
Interval 8.1 to 78.7
|
12.8 titer
Interval 4.9 to 33.6
|
8.3 titer
Interval 2.6 to 26.2
|
3.3 titer
Interval 1.3 to 8.4
|
1.6 titer
Interval 0.4 to 6.4
|
SECONDARY outcome
Timeframe: Day 197Population: The analysis population includes all participants who received study vaccination and for whom data were available at any particular timepoint
Mucosal vaccine-specific IgA geometric mean titer (GMT) was measured by ELISA in nasal lavage specimens collected immediately before intramuscular H5N1 IIV vaccination (study Day 197)
Outcome measures
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
n=8 Participants
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
n=7 Participants
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
n=6 Participants
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IgA Geometric Mean Titer (GMT) at Day 197
|
18.3 titer
Interval 8.4 to 39.5
|
9.0 titer
Interval 2.7 to 29.5
|
4.6 titer
Interval 0.9 to 23.3
|
3.5 titer
Interval 1.0 to 12.7
|
4.2 titer
Interval 0.9 to 20.0
|
Adverse Events
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
rH5 (100 µg) Control - Pipette - IN
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Saline (Placebo) - Pipette - IN
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BW-1014: 50 µg rH5 in 20% NE - Pipette - IN
n=8 participants at risk
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 25 µg rH5 in 20% NE - Pipette - IN
n=8 participants at risk
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 25 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
BW-1014: 100 µg rH5 in 20% NE - Pipette - IN
n=8 participants at risk
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN: 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
rH5 (100 µg) Control - Pipette - IN
n=8 participants at risk
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN: 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
Saline (Placebo) - Pipette - IN
n=8 participants at risk
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN: Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM: 90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
12.5%
1/8 • Number of events 1 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
12.5%
1/8 • Number of events 1 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
|
Eye disorders
Dry eye
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
12.5%
1/8 • Number of events 1 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
|
Gastrointestinal disorders
Malpositioned teeth
|
12.5%
1/8 • Number of events 1 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
|
Gastrointestinal disorders
Toothache
|
12.5%
1/8 • Number of events 1 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
12.5%
1/8 • Number of events 1 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
12.5%
1/8 • Number of events 1 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
12.5%
1/8 • Number of events 1 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
|
Infections and infestations
COVID-19
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
25.0%
2/8 • Number of events 2 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
25.0%
2/8 • Number of events 2 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
37.5%
3/8 • Number of events 3 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
12.5%
1/8 • Number of events 1 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
|
Infections and infestations
Hordeolum
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
12.5%
1/8 • Number of events 1 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
|
Infections and infestations
Influenza
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
12.5%
1/8 • Number of events 1 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
|
Infections and infestations
Oral herpes
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
12.5%
1/8 • Number of events 1 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
|
Infections and infestations
Otitis externa
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
12.5%
1/8 • Number of events 1 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
12.5%
1/8 • Number of events 1 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
25.0%
2/8 • Number of events 2 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
|
Injury, poisoning and procedural complications
Animal bite
|
12.5%
1/8 • Number of events 1 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
|
Investigations
Blood pressure diastolic increased
|
12.5%
1/8 • Number of events 1 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
12.5%
1/8 • Number of events 1 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
12.5%
1/8 • Number of events 1 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
12.5%
1/8 • Number of events 1 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
12.5%
1/8 • Number of events 1 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
25.0%
2/8 • Number of events 2 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
12.5%
1/8 • Number of events 1 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
12.5%
1/8 • Number of events 1 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
0.00%
0/8 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
12.5%
1/8 • Number of events 1 • Through the completion of the study (Day 393)
Unsolicited adverse events were defined as any adverse events other than solicited adverse events that occurred following study vaccination. Unsolicited adverse events were systematically assessed at each study visit through discussions between the investigator and participant, investigator observations, and evaluation of clinically significant hematologic and biochemical laboratory abnormalities (Grade 1 or higher).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place