Trial Outcomes & Findings for Safety and Immunogenicity of the Sing2016 M2SR H3N2 Monovalent Influenza Vaccine in Adults Ages 50 to 85 Years Old (NCT NCT04785794)
NCT ID: NCT04785794
Last Updated: 2023-06-15
Results Overview
The number and percentage of study participants who experience local (at the dose administration site) and systemic (throughout the body) reactions during the 7 days after administration of investigational M2SR vaccine or placebo. Solicited and unsolicited signs and symptoms were reported as AEs after review by the Investigator or designee, either separately using the corresponding Medical Dictionary for Regulatory Activities (MedDRA) terminology of the sign or symptom or combined using the appropriate term.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
122 participants
Primary outcome timeframe
Day 1 to Day 8
Results posted on
2023-06-15
Participant Flow
Cohort 1 included subjects ages 50-64 years as a safety check prior to age-escalating to older adults. Cohort 2 included a lead-in group of subjects 65-85 years as a safety check prior to enrolling the expansion group, Cohort 3, in the same age range. Cohorts 2 and 3 received the same treatments and results are combined for these subjects.
Participant milestones
| Measure |
M2SR Dose, 50-64 Years of Age
Intranasal M2SR vaccine followed by standard, licensed IIV
Sing2016 M2SR H3N2 influenza vaccine: This group will receive a dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally on Day 1 followed by IIV at least 28 days later.
|
Placebo Dose, 50-64 Years of Age
Intranasal physiological saline followed by standard, licensed IIV
Placebo: This group will receive saline placebo administered intranasally on Day 1 followed by IIV at least 28 days later.
|
M2SR Dose, 65-85 Years of Age
Intranasal M2SR vaccine followed by licensed IIV recommended for people 65 years and older
Sing2016 M2SR H3N2 influenza vaccine: This group will receive a dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally on Day 1 followed by IIV at least 28 days later.
|
Placebo Dose, 65-85 Years of Age
Intranasal physiological saline followed by licensed IIV recommended for people 65 years and older
Placebo: This group will receive saline placebo administered intranasally on Day 1 followed by IIV at least 28 days later.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
5
|
70
|
37
|
|
Overall Study
COMPLETED
|
9
|
5
|
67
|
37
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Immunogenicity of the Sing2016 M2SR H3N2 Monovalent Influenza Vaccine in Adults Ages 50 to 85 Years Old
Baseline characteristics by cohort
| Measure |
M2SR Dose, 50-64 Years of Age
n=10 Participants
Intranasal M2SR vaccine followed by standard, licensed IIV
Sing2016 M2SR H3N2 influenza vaccine: This group will receive a dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally on Day 1 followed by IIV at least 28 days later.
|
Placebo Dose, 50-64 Years of Age
n=5 Participants
Intranasal physiological saline followed by standard, licensed IIV
Placebo: This group will receive saline placebo administered intranasally on Day 1 followed by IIV at least 28 days later.
|
M2SR Dose, 65-85 Years of Age
n=70 Participants
Intranasal M2SR vaccine followed by licensed IIV recommended for people 65 years and older
Sing2016 M2SR H3N2 influenza vaccine: This group will receive a dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally on Day 1 followed by IIV at least 28 days later.
|
Placebo Dose, 65-85 Years of Age
n=37 Participants
Intranasal physiological saline followed by licensed IIV recommended for people 65 years and older
Placebo: This group will receive saline placebo administered intranasally on Day 1 followed by IIV at least 28 days later.
|
Total
n=122 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
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
37 Participants
n=7 Participants
|
107 Participants
n=31 Participants
|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 3.1 • n=99 Participants
|
57 years
STANDARD_DEVIATION 2.9 • n=107 Participants
|
70 years
STANDARD_DEVIATION 4.2 • n=206 Participants
|
73 years
STANDARD_DEVIATION 4.6 • n=7 Participants
|
72 years
STANDARD_DEVIATION 6.6 • n=31 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
78 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
44 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
35 Participants
n=7 Participants
|
112 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 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
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
34 Participants
n=7 Participants
|
110 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
5 participants
n=107 Participants
|
70 participants
n=206 Participants
|
37 participants
n=7 Participants
|
122 participants
n=31 Participants
|
|
Baseline HAI titer to A/Sing2016
<40
|
8 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
63 Participants
n=31 Participants
|
|
Baseline HAI titer to A/Sing2016
40 to <=320
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
59 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 8Population: All subjects who received an IP dose
The number and percentage of study participants who experience local (at the dose administration site) and systemic (throughout the body) reactions during the 7 days after administration of investigational M2SR vaccine or placebo. Solicited and unsolicited signs and symptoms were reported as AEs after review by the Investigator or designee, either separately using the corresponding Medical Dictionary for Regulatory Activities (MedDRA) terminology of the sign or symptom or combined using the appropriate term.
Outcome measures
| Measure |
M2SR Dose, 50-64 Years of Age
n=10 Participants
Intranasal M2SR vaccine followed by standard, licensed IIV
Sing2016 M2SR H3N2 influenza vaccine: This group will receive a dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally on Day 1 followed by IIV at least 28 days later.
|
Placebo Dose, 50-64 Years of Age
n=5 Participants
Intranasal physiological saline followed by standard, licensed IIV
Placebo: This group will receive saline placebo administered intranasally on Day 1 followed by IIV at least 28 days later.
|
M2SR Dose, 65-85 Years of Age
n=70 Participants
Intranasal M2SR vaccine followed by licensed IIV recommended for people 65 years and older
Sing2016 M2SR H3N2 influenza vaccine: This group will receive a dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally on Day 1 followed by IIV at least 28 days later.
|
Placebo Dose, 65-85 Years of Age
n=37 Participants
Intranasal physiological saline followed by licensed IIV recommended for people 65 years and older
Placebo: This group will receive saline placebo administered intranasally on Day 1 followed by IIV at least 28 days later.
|
|---|---|---|---|---|
|
Treatment Emergent AEs During 7 Days After Experimental Treatment
|
1 Participants
|
0 Participants
|
12 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 29The number and percentage of study participants who experience a treatment emergent AE during the 28 days after administration of investigational M2SR vaccine or placebo. Unsolicited signs and symptoms were reported as AEs after review by the Investigator or designee, either separately using the corresponding MedDRA terminology of the sign or symptom or combined using the appropriate term.
Outcome measures
| Measure |
M2SR Dose, 50-64 Years of Age
n=10 Participants
Intranasal M2SR vaccine followed by standard, licensed IIV
Sing2016 M2SR H3N2 influenza vaccine: This group will receive a dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally on Day 1 followed by IIV at least 28 days later.
|
Placebo Dose, 50-64 Years of Age
n=5 Participants
Intranasal physiological saline followed by standard, licensed IIV
Placebo: This group will receive saline placebo administered intranasally on Day 1 followed by IIV at least 28 days later.
|
M2SR Dose, 65-85 Years of Age
n=70 Participants
Intranasal M2SR vaccine followed by licensed IIV recommended for people 65 years and older
Sing2016 M2SR H3N2 influenza vaccine: This group will receive a dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally on Day 1 followed by IIV at least 28 days later.
|
Placebo Dose, 65-85 Years of Age
n=37 Participants
Intranasal physiological saline followed by licensed IIV recommended for people 65 years and older
Placebo: This group will receive saline placebo administered intranasally on Day 1 followed by IIV at least 28 days later.
|
|---|---|---|---|---|
|
Treatment Emergent AEs During 28 Days After Experimental Treatment
|
1 Participants
|
1 Participants
|
16 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Time of enrollment through 28 days after receipt of IIV where the IIV was administered an average of 49 days post-IP and with an interval up to 91 days later.Population: Numbers of subjects analyzed for SAEs includes 2 subjects who were administered IIV but who did not have biological samples collected and therefore were not considered to have completed trial. Thus, the participant flow shows 9 subjects completed while safety shows 10 subjects for the M2SR dose 50-64 years of age. Similarly, the participant flow shows 67 subjects completed while safety shows 68 subjects for the M2SR dose 65-85 years of age.
The number and percentage of study participants who experience SAEs from the time of study entry through 28 days after receipt of IIV. Unsolicited signs and symptoms were reported as AEs after review by the Investigator or designee, either separately using the corresponding MedDRA terminology of the sign or symptom or combined using the appropriate term.
Outcome measures
| Measure |
M2SR Dose, 50-64 Years of Age
n=10 Participants
Intranasal M2SR vaccine followed by standard, licensed IIV
Sing2016 M2SR H3N2 influenza vaccine: This group will receive a dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally on Day 1 followed by IIV at least 28 days later.
|
Placebo Dose, 50-64 Years of Age
n=5 Participants
Intranasal physiological saline followed by standard, licensed IIV
Placebo: This group will receive saline placebo administered intranasally on Day 1 followed by IIV at least 28 days later.
|
M2SR Dose, 65-85 Years of Age
n=68 Participants
Intranasal M2SR vaccine followed by licensed IIV recommended for people 65 years and older
Sing2016 M2SR H3N2 influenza vaccine: This group will receive a dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally on Day 1 followed by IIV at least 28 days later.
|
Placebo Dose, 65-85 Years of Age
n=37 Participants
Intranasal physiological saline followed by licensed IIV recommended for people 65 years and older
Placebo: This group will receive saline placebo administered intranasally on Day 1 followed by IIV at least 28 days later.
|
|---|---|---|---|---|
|
SAEs Through 28 Days After Licensed IIV Treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
M2SR Dose, 50-64 Years of Age
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo Dose, 50-64 Years of Age
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
M2SR Dose, 65-85 Years of Age
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo Dose, 65-85 Years of Age
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
M2SR Dose, 50-64 Years of Age
n=10 participants at risk
Intranasal M2SR vaccine followed by standard, licensed IIV
Sing2016 M2SR H3N2 influenza vaccine: This group will receive a dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally on Day 1 followed by IIV at least 28 days later.
|
Placebo Dose, 50-64 Years of Age
n=5 participants at risk
Intranasal physiological saline followed by standard, licensed IIV
Placebo: This group will receive saline placebo administered intranasally on Day 1 followed by IIV at least 28 days later.
|
M2SR Dose, 65-85 Years of Age
n=70 participants at risk
Intranasal M2SR vaccine followed by licensed IIV recommended for people 65 years and older
Sing2016 M2SR H3N2 influenza vaccine: This group will receive a dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally on Day 1 followed by IIV at least 28 days later.
|
Placebo Dose, 65-85 Years of Age
n=37 participants at risk
Intranasal physiological saline followed by licensed IIV recommended for people 65 years and older
Placebo: This group will receive saline placebo administered intranasally on Day 1 followed by IIV at least 28 days later.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
cough
|
10.0%
1/10 • IP administration until 28 days post-IIV (where interval between IP and IIV was up to 91 days with an average span of 49 days)
Includes treatment emergent AEs
|
0.00%
0/5 • IP administration until 28 days post-IIV (where interval between IP and IIV was up to 91 days with an average span of 49 days)
Includes treatment emergent AEs
|
1.4%
1/70 • IP administration until 28 days post-IIV (where interval between IP and IIV was up to 91 days with an average span of 49 days)
Includes treatment emergent AEs
|
2.7%
1/37 • IP administration until 28 days post-IIV (where interval between IP and IIV was up to 91 days with an average span of 49 days)
Includes treatment emergent AEs
|
|
Nervous system disorders
headache
|
0.00%
0/10 • IP administration until 28 days post-IIV (where interval between IP and IIV was up to 91 days with an average span of 49 days)
Includes treatment emergent AEs
|
0.00%
0/5 • IP administration until 28 days post-IIV (where interval between IP and IIV was up to 91 days with an average span of 49 days)
Includes treatment emergent AEs
|
1.4%
1/70 • IP administration until 28 days post-IIV (where interval between IP and IIV was up to 91 days with an average span of 49 days)
Includes treatment emergent AEs
|
5.4%
2/37 • IP administration until 28 days post-IIV (where interval between IP and IIV was up to 91 days with an average span of 49 days)
Includes treatment emergent AEs
|
|
Musculoskeletal and connective tissue disorders
muscle strain
|
0.00%
0/10 • IP administration until 28 days post-IIV (where interval between IP and IIV was up to 91 days with an average span of 49 days)
Includes treatment emergent AEs
|
20.0%
1/5 • IP administration until 28 days post-IIV (where interval between IP and IIV was up to 91 days with an average span of 49 days)
Includes treatment emergent AEs
|
0.00%
0/70 • IP administration until 28 days post-IIV (where interval between IP and IIV was up to 91 days with an average span of 49 days)
Includes treatment emergent AEs
|
0.00%
0/37 • IP administration until 28 days post-IIV (where interval between IP and IIV was up to 91 days with an average span of 49 days)
Includes treatment emergent AEs
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first publication of the results of the Study will be made in conjunction with the presentation of a joint, multicenter publication of the Study results with the investigators and the institutions from all appropriate sites contributing data. If such a multicenter publication is not submitted within 24 months after conclusion of the Study at all sites, then Investigator may publish the results from their Site individually,
- Publication restrictions are in place
Restriction type: OTHER