Trial Outcomes & Findings for Immunogenicity and Safety Study of Inactivated Subunit H5N1 Influenza Vaccine in Prior Recipients of Live Attenuated H2N2, H6N1 and H9N2 Influenza Vaccines and in H5N1 and Live Attenuated Vaccine Naïve Individuals (NCT NCT03816878)
NCT ID: NCT03816878
Last Updated: 2025-09-22
Results Overview
As measured by enzyme-linked immunosorbent assay (ELISA) and microneutralization assay (MN) using the chimeric cH6/N1 probe
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Measured through Day 28
Results posted on
2025-09-22
Participant Flow
Participant milestones
| Measure |
Cohort 1: pLAIV Recipients
Participants who have received the pandemic live attenuated influenza vaccines (pLAIVs) H2N2, H6N1, or H9N2 during a previous CIR study will receive a single dose of 0.5 mL H5N1 pISV vaccine at Day 0.
H5N1 pISV: Administered as an intramuscular (IM) injection
|
Cohort 2: pLAIV Naive
Participants who have never previously received a pLAIV will receive one dose of 0.5 mL H5N1 pISV vaccine at Day 0.
H5N1 pISV: Administered as an intramuscular (IM) injection
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
21
|
|
Overall Study
COMPLETED
|
10
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1: pLAIV Recipients
Participants who have received the pandemic live attenuated influenza vaccines (pLAIVs) H2N2, H6N1, or H9N2 during a previous CIR study will receive a single dose of 0.5 mL H5N1 pISV vaccine at Day 0.
H5N1 pISV: Administered as an intramuscular (IM) injection
|
Cohort 2: pLAIV Naive
Participants who have never previously received a pLAIV will receive one dose of 0.5 mL H5N1 pISV vaccine at Day 0.
H5N1 pISV: Administered as an intramuscular (IM) injection
|
|---|---|---|
|
Overall Study
Taken off study after Day 28 due to unrelated serious adverse event requiring hospitalization
|
1
|
0
|
|
Overall Study
Volunteer taken off study due to incarceration
|
0
|
1
|
Baseline Characteristics
Immunogenicity and Safety Study of Inactivated Subunit H5N1 Influenza Vaccine in Prior Recipients of Live Attenuated H2N2, H6N1 and H9N2 Influenza Vaccines and in H5N1 and Live Attenuated Vaccine Naïve Individuals
Baseline characteristics by cohort
| Measure |
Cohort 1: pLAIV Recipients
n=11 Participants
Participants who have received the pandemic live attenuated influenza vaccines (pLAIVs) H2N2, H6N1, or H9N2 during a previous CIR study will receive a single dose of 0.5 mL H5N1 pISV vaccine at Day 0.
H5N1 pISV: Administered as an intramuscular (IM) injection
|
Cohort 2: pLAIV Naive
n=20 Participants
Participants who have never previously received a pLAIV will receive one dose of 0.5 mL H5N1 pISV vaccine at Day 0.
H5N1 pISV: Administered as an intramuscular (IM) injection
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
43.7 years
n=99 Participants
|
38 years
n=107 Participants
|
41 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=99 Participants
|
20 participants
n=107 Participants
|
31 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Measured through Day 28As measured by enzyme-linked immunosorbent assay (ELISA) and microneutralization assay (MN) using the chimeric cH6/N1 probe
Outcome measures
| Measure |
Cohort 1: pLAIV Recipients
n=11 Participants
Participants who have received the pandemic live attenuated influenza vaccines (pLAIVs) H2N2, H6N1, or H9N2 during a previous CIR study will receive a single dose of 0.5 mL H5N1 pISV vaccine at Day 0.
H5N1 pISV: Administered as an intramuscular (IM) injection
|
Cohort 2: pLAIV Naive
n=20 Participants
Participants who have never previously received a pLAIV will receive one dose of 0.5 mL H5N1 pISV vaccine at Day 0.
H5N1 pISV: Administered as an intramuscular (IM) injection
|
|---|---|---|
|
Fold Rise in Titer of Anti-group 1 Stalk-antibodies in Recipients of the Pandemic Live Attenuated Influenza Vaccines (pLAIVs) (H2N2, H6N1 and H9N2) Compared to the Control pLAIV-naïve Cohort
Day 0
|
1.5 fold rise
Standard Deviation 1.2
|
1 fold rise
Standard Deviation 0
|
|
Fold Rise in Titer of Anti-group 1 Stalk-antibodies in Recipients of the Pandemic Live Attenuated Influenza Vaccines (pLAIVs) (H2N2, H6N1 and H9N2) Compared to the Control pLAIV-naïve Cohort
Day 28
|
1.4 fold rise
Standard Deviation 1.2
|
1 fold rise
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Measured through Day 28 for non serious adverse eventsGraded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017
Outcome measures
| Measure |
Cohort 1: pLAIV Recipients
n=11 Participants
Participants who have received the pandemic live attenuated influenza vaccines (pLAIVs) H2N2, H6N1, or H9N2 during a previous CIR study will receive a single dose of 0.5 mL H5N1 pISV vaccine at Day 0.
H5N1 pISV: Administered as an intramuscular (IM) injection
|
Cohort 2: pLAIV Naive
n=20 Participants
Participants who have never previously received a pLAIV will receive one dose of 0.5 mL H5N1 pISV vaccine at Day 0.
H5N1 pISV: Administered as an intramuscular (IM) injection
|
|---|---|---|
|
Number of Participants With Vaccine-related Adverse Events in the pLAIV Compared to the Control Cohort
Injection site erythema
|
0 number of participants
|
1 number of participants
|
|
Number of Participants With Vaccine-related Adverse Events in the pLAIV Compared to the Control Cohort
Injection site induration
|
1 number of participants
|
0 number of participants
|
|
Number of Participants With Vaccine-related Adverse Events in the pLAIV Compared to the Control Cohort
Injection site pain
|
1 number of participants
|
5 number of participants
|
|
Number of Participants With Vaccine-related Adverse Events in the pLAIV Compared to the Control Cohort
Malaise
|
1 number of participants
|
1 number of participants
|
|
Number of Participants With Vaccine-related Adverse Events in the pLAIV Compared to the Control Cohort
Pain
|
1 number of participants
|
0 number of participants
|
Adverse Events
Cohort 1: pLAIV Recipients
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 2: pLAIV Naive
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: pLAIV Recipients
n=11 participants at risk
Participants who have received the pandemic live attenuated influenza vaccines (pLAIVs) H2N2, H6N1, or H9N2 during a previous CIR study will receive a single dose of 0.5 mL H5N1 pISV vaccine at Day 0.
H5N1 pISV: Administered as an intramuscular (IM) injection
|
Cohort 2: pLAIV Naive
n=20 participants at risk
Participants who have never previously received a pLAIV will receive one dose of 0.5 mL H5N1 pISV vaccine at Day 0.
H5N1 pISV: Administered as an intramuscular (IM) injection
|
|---|---|---|
|
Gastrointestinal disorders
Surgery
|
9.1%
1/11 • Number of events 1 • 90 days beginning at study vaccination
|
0.00%
0/20 • 90 days beginning at study vaccination
|
Other adverse events
| Measure |
Cohort 1: pLAIV Recipients
n=11 participants at risk
Participants who have received the pandemic live attenuated influenza vaccines (pLAIVs) H2N2, H6N1, or H9N2 during a previous CIR study will receive a single dose of 0.5 mL H5N1 pISV vaccine at Day 0.
H5N1 pISV: Administered as an intramuscular (IM) injection
|
Cohort 2: pLAIV Naive
n=20 participants at risk
Participants who have never previously received a pLAIV will receive one dose of 0.5 mL H5N1 pISV vaccine at Day 0.
H5N1 pISV: Administered as an intramuscular (IM) injection
|
|---|---|---|
|
Cardiac disorders
Blood pressure increased
|
9.1%
1/11 • Number of events 1 • 90 days beginning at study vaccination
|
5.0%
1/20 • Number of events 1 • 90 days beginning at study vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
9.1%
1/11 • Number of events 1 • 90 days beginning at study vaccination
|
0.00%
0/20 • 90 days beginning at study vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
9.1%
1/11 • Number of events 1 • 90 days beginning at study vaccination
|
0.00%
0/20 • 90 days beginning at study vaccination
|
|
Infections and infestations
Upper Respiratory Infection
|
9.1%
1/11 • Number of events 1 • 90 days beginning at study vaccination
|
5.0%
1/20 • Number of events 1 • 90 days beginning at study vaccination
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • Number of events 1 • 90 days beginning at study vaccination
|
0.00%
0/20 • 90 days beginning at study vaccination
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/11 • 90 days beginning at study vaccination
|
5.0%
1/20 • Number of events 1 • 90 days beginning at study vaccination
|
|
Gastrointestinal disorders
Tooth Disorder
|
0.00%
0/11 • 90 days beginning at study vaccination
|
15.0%
3/20 • Number of events 3 • 90 days beginning at study vaccination
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/11 • 90 days beginning at study vaccination
|
5.0%
1/20 • Number of events 1 • 90 days beginning at study vaccination
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/11 • 90 days beginning at study vaccination
|
5.0%
1/20 • Number of events 1 • 90 days beginning at study vaccination
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/11 • 90 days beginning at study vaccination
|
5.0%
1/20 • Number of events 1 • 90 days beginning at study vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/11 • 90 days beginning at study vaccination
|
5.0%
1/20 • Number of events 1 • 90 days beginning at study vaccination
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/11 • 90 days beginning at study vaccination
|
5.0%
1/20 • Number of events 1 • 90 days beginning at study vaccination
|
|
General disorders
Injection site erythema
|
0.00%
0/11 • 90 days beginning at study vaccination
|
5.0%
1/20 • Number of events 1 • 90 days beginning at study vaccination
|
|
General disorders
Injection site induration
|
9.1%
1/11 • Number of events 1 • 90 days beginning at study vaccination
|
0.00%
0/20 • 90 days beginning at study vaccination
|
|
General disorders
Injection site pain
|
9.1%
1/11 • Number of events 1 • 90 days beginning at study vaccination
|
25.0%
5/20 • Number of events 5 • 90 days beginning at study vaccination
|
|
General disorders
Malaise
|
9.1%
1/11 • Number of events 1 • 90 days beginning at study vaccination
|
5.0%
1/20 • Number of events 1 • 90 days beginning at study vaccination
|
|
General disorders
Pain
|
9.1%
1/11 • Number of events 1 • 90 days beginning at study vaccination
|
0.00%
0/20 • 90 days beginning at study vaccination
|
Additional Information
Kawsar Talaat
Johns Hopkins University Center for Immunization Research
Phone: 410-336-9164
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place