Trial Outcomes & Findings for Systems Analyses of the Immune Response to the Seasonal Influenza Vaccine (NCT NCT04025580)
NCT ID: NCT04025580
Last Updated: 2024-01-02
Results Overview
Change in antibody titer response to vaccination, as measured by microneutralization titers at day 0 and day 70 and its relationship with novel baseline biomarkers
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
98 participants
Primary outcome timeframe
Day 0 and Day 28 Reported in Manuscript
Results posted on
2024-01-02
Participant Flow
Participant milestones
| Measure |
Year 1 Healthy Volunteers (Pre-COVID-19)
Healthy Volunteer between ages 18-65
Flucelvax: Seasonal influenza vaccine
Fluzone High Dose: Seasonal influenza vaccine for adults ages 65 and older
|
Year 2 COVID-19-recovered Individuals
Healthy Volunteer between ages 18-65
Flucelvax: Seasonal influenza vaccine
Fluzone High Dose: Seasonal influenza vaccine for adults ages 65 and older
|
Year 2 Individuals With no History of COVID-19
Healthy Volunteer between ages 18-65
Flucelvax: Seasonal influenza vaccine
Fluzone High Dose: Seasonal influenza vaccine for adults ages 65 and older
|
|---|---|---|---|
|
Overall Study
STARTED
|
24
|
34
|
40
|
|
Overall Study
COMPLETED
|
13
|
34
|
40
|
|
Overall Study
NOT COMPLETED
|
11
|
0
|
0
|
Reasons for withdrawal
| Measure |
Year 1 Healthy Volunteers (Pre-COVID-19)
Healthy Volunteer between ages 18-65
Flucelvax: Seasonal influenza vaccine
Fluzone High Dose: Seasonal influenza vaccine for adults ages 65 and older
|
Year 2 COVID-19-recovered Individuals
Healthy Volunteer between ages 18-65
Flucelvax: Seasonal influenza vaccine
Fluzone High Dose: Seasonal influenza vaccine for adults ages 65 and older
|
Year 2 Individuals With no History of COVID-19
Healthy Volunteer between ages 18-65
Flucelvax: Seasonal influenza vaccine
Fluzone High Dose: Seasonal influenza vaccine for adults ages 65 and older
|
|---|---|---|---|
|
Overall Study
COVID 19 restrictions at Clinical Center
|
11
|
0
|
0
|
Baseline Characteristics
Systems Analyses of the Immune Response to the Seasonal Influenza Vaccine
Baseline characteristics by cohort
| Measure |
Year 1 Healthy Volunteers (Pre-COVID-19)
n=24 Participants
Healthy Volunteer between ages 18-65
Flucelvax: Seasonal influenza vaccine
Fluzone High Dose: Seasonal influenza vaccine for adults ages 65 and older
|
Year 2 COVID-19-recovered Individuals
n=34 Participants
Healthy Volunteer between ages 18-65
Flucelvax: Seasonal influenza vaccine
Fluzone High Dose: Seasonal influenza vaccine for adults ages 65 and older
|
Year 2 Individuals With no History of COVID-19
n=40 Participants
Healthy Volunteer between ages 18-65
Flucelvax: Seasonal influenza vaccine
Fluzone High Dose: Seasonal influenza vaccine for adults ages 65 and older
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
81 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
53 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
45 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
89 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
70 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=93 Participants
|
34 participants
n=4 Participants
|
40 participants
n=27 Participants
|
98 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Day 0 and Day 28 Reported in ManuscriptPopulation: Healthy Control and COVID-19 Recovered participants under 65 years of age for Year 2. Year 1 data not able to be generated/analyzed due to COVID-19 restrictions at the clinical center which prevented study from being completed. Year 1 samples were obtained but not analyzed and will never be analyzed.
Change in antibody titer response to vaccination, as measured by microneutralization titers at day 0 and day 70 and its relationship with novel baseline biomarkers
Outcome measures
| Measure |
Year 2-Healthy Volunteers, Male, No History of COVID-19
n=14 Participants
Healthy Control Males under 65 years of age with no history of COVID-19
|
Year 2-Healthy Volunteers, Female, No History of COVID-19
n=16 Participants
Healthy Control Females under 65 years of age with no history of COVID-19
|
Year 2-COVID-19 Recovered Males
n=14 Participants
COVID-19 Recovered Males under 65 years of age
|
Year 2-COVID-19 Recovered Females
n=15 Participants
COVID-19 Recovered Females under 65 years of age
|
|---|---|---|---|---|
|
Microneutralization Titers
Fold Change for A/CNIC/1909 Strain
|
0.769 Log2 Fold Change
Interval 0.266 to 1.272
|
1.313 Log2 Fold Change
Interval 0.517 to 2.108
|
1.716 Log2 Fold Change
Interval 0.691 to 2.741
|
1.333 Log2 Fold Change
Interval 0.793 to 1.874
|
|
Microneutralization Titers
Fold Change for B/Washington/02/2019 Strain
|
0.308 Log2 Fold Change
Interval -0.073 to 0.689
|
0.625 Log2 Fold Change
Interval 0.242 to 1.008
|
0.857 Log2 Fold Change
Interval 0.045 to 1.669
|
0.800 Log2 Fold Change
Interval 0.132 to 1.468
|
|
Microneutralization Titers
Fold Change for A/HongKong/2671/2019 Strain
|
1.154 Log2 Fold Change
Interval 0.42 to 1.888
|
1.063 Log2 Fold Change
Interval 0.464 to 1.661
|
1.501 Log2 Fold Change
Interval 0.601 to 2.401
|
1.267 Log2 Fold Change
Interval 0.471 to 2.063
|
|
Microneutralization Titers
Fold Change for B/Phuket/3073/2013 Strain
|
0.462 Log2 Fold Change
Interval 0.148 to 0.775
|
0.313 Log2 Fold Change
Interval 0.057 to 0.568
|
0.929 Log2 Fold Change
Interval 0.067 to 1.79
|
0.800 Log2 Fold Change
Interval 0.371 to 1.229
|
Adverse Events
Flucelvax, Fluvirin, or Fluzone High Dose
Serious events: 0 serious events
Other events: 72 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Flucelvax, Fluvirin, or Fluzone High Dose
n=98 participants at risk
Healthy Volunteer between ages 18-65 receiving Flucelvax
Flucelvax: Seasonal influenza vaccine
Fluvirin: Seasonal influenza vaccine
Fluzone High Dose: Seasonal influenza vaccine for adults ages 65 and older
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.3%
16/98 • Number of events 16 • Through Day 7 post vaccination
Adverse event information was collected on Day 1 and Day 7 post vaccination
|
|
General disorders
Pain at Injection Site
|
63.3%
62/98 • Number of events 62 • Through Day 7 post vaccination
Adverse event information was collected on Day 1 and Day 7 post vaccination
|
|
Nervous system disorders
Headache
|
20.4%
20/98 • Number of events 20 • Through Day 7 post vaccination
Adverse event information was collected on Day 1 and Day 7 post vaccination
|
|
General disorders
Injection Site Swelling
|
4.1%
4/98 • Number of events 4 • Through Day 7 post vaccination
Adverse event information was collected on Day 1 and Day 7 post vaccination
|
|
General disorders
Injection Site Erythema
|
2.0%
2/98 • Number of events 2 • Through Day 7 post vaccination
Adverse event information was collected on Day 1 and Day 7 post vaccination
|
|
Gastrointestinal disorders
Diarrhea
|
1.0%
1/98 • Number of events 1 • Through Day 7 post vaccination
Adverse event information was collected on Day 1 and Day 7 post vaccination
|
|
Nervous system disorders
Dizziness
|
1.0%
1/98 • Number of events 1 • Through Day 7 post vaccination
Adverse event information was collected on Day 1 and Day 7 post vaccination
|
|
General disorders
Fatigue
|
8.2%
8/98 • Number of events 8 • Through Day 7 post vaccination
Adverse event information was collected on Day 1 and Day 7 post vaccination
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place