Trial Outcomes & Findings for Early Immune Responses to Inactivated Influenza Vaccine: a Pilot Study (NCT NCT01522248)
NCT ID: NCT01522248
Last Updated: 2019-03-15
Results Overview
This was an exploratory trial to look at the kinetics of early cytokine response to influenza vaccine. Serum collected was assessed for cytokines, and PBMCs may be assessed for innate and adaptive immune responses, as well as for genetic markers associated with immune responses to vaccination. Data for Cohort 1 reported as 0 hours and 24 hours. Data for Cohort 2 reported as 0 hours and 16 hours. Data was combined for the Cohorts and reported as 0 hours (baseline) and 14 days.
COMPLETED
NA
20 participants
0 hours, 16 hours, 24 hours, 14 days
2019-03-15
Participant Flow
Participant milestones
| Measure |
Cohort 1
receives vaccine in morning. Blood drawn at 3, 7, 24, and 48 hours and 14 days after vaccination.
Trivalent Inactivated Influenza vaccine: 0.5 ml IM once only
|
Cohort 2
receives vaccine in evening, Blood drawn 16, 40 hours and 14 days after vaccination.
Trivalent Inactivated Influenza vaccine: 0.5 ml IM once only
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1
receives vaccine in morning. Blood drawn at 3, 7, 24, and 48 hours and 14 days after vaccination.
Trivalent Inactivated Influenza vaccine: 0.5 ml IM once only
|
Cohort 2
receives vaccine in evening, Blood drawn 16, 40 hours and 14 days after vaccination.
Trivalent Inactivated Influenza vaccine: 0.5 ml IM once only
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Early Immune Responses to Inactivated Influenza Vaccine: a Pilot Study
Baseline characteristics by cohort
| Measure |
Cohort 1
n=10 Participants
Received vaccine in morning. Blood drawn at 3, 7, 24 and 48 hours and 14 days after vaccination. Trivalent Inactivated Influenza vaccine 0.5ml IM once only
|
Cohort 2
n=10 Participants
Received vaccine in evening. Blood drawn 16 and 40 hours and 14 days after vaccination. Trivalent Inactivated Influenza vaccine 0.5 ml IM once only
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
38.1 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
35.8 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
36.9 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 hours, 16 hours, 24 hours, 14 daysPopulation: Data for Cohort 1 reported as 0 hours and 24 hours. Data for Cohort 2 reported as 0 hours and 16 hours. Data was combined for the Cohorts and reported as 0 hours (baseline) and 14 days
This was an exploratory trial to look at the kinetics of early cytokine response to influenza vaccine. Serum collected was assessed for cytokines, and PBMCs may be assessed for innate and adaptive immune responses, as well as for genetic markers associated with immune responses to vaccination. Data for Cohort 1 reported as 0 hours and 24 hours. Data for Cohort 2 reported as 0 hours and 16 hours. Data was combined for the Cohorts and reported as 0 hours (baseline) and 14 days.
Outcome measures
| Measure |
Cohort 1
n=10 Participants
Cytokine Results 0 hours and 24 hours
|
Cohort 2
n=10 Participants
Cytokine results 0hours and 16 hours
|
Cohort 1 & 2
n=20 Participants
Combined Cytokine results 0 hours and 14 days
|
|---|---|---|---|
|
Levels of Cytokine Interferon Gamma (IFN-gamma) Responses to Inactivated Influenza Vaccine
IFN gamma
|
1.3 pg/mL
Standard Deviation 1.7
|
1.4 pg/mL
Standard Deviation 2.2
|
1.3 pg/mL
Standard Deviation 1.9
|
|
Levels of Cytokine Interferon Gamma (IFN-gamma) Responses to Inactivated Influenza Vaccine
IFN-gamma
|
6.9 pg/mL
Standard Deviation 3.0
|
5.1 pg/mL
Standard Deviation 5.0
|
1.2 pg/mL
Standard Deviation 0.8
|
PRIMARY outcome
Timeframe: 0 hours, 16 hours, 24 hours, 14 daysPopulation: Data for Cohort 1 reported as 0 hours and 24 hours. Data for Cohort 2 reported as 0 hours and 16 hours. Data was combined for the Cohorts and reported as 0 hours (baseline) and 14 days.
This was an exploratory trial to look at the kinetics of early cytokine response to influenza vaccine. Serum collected was assessed for cytokines, and PBMCs may be assessed for innate and adaptive immune responses, as well as for genetic markers associated with immune responses to vaccination. Data for Cohort 1 reported as 0 hours and 24 hours. Data for Cohort 2 reported as 0 hours and 16 hours. Data was combined for the Cohorts and reported as 0 hours (baseline) and 14 days.
Outcome measures
| Measure |
Cohort 1
n=10 Participants
Cytokine Results 0 hours and 24 hours
|
Cohort 2
n=10 Participants
Cytokine results 0hours and 16 hours
|
Cohort 1 & 2
n=20 Participants
Combined Cytokine results 0 hours and 14 days
|
|---|---|---|---|
|
Levels of Cytokine Interleukin 8 (IL-8) Cytokine Response to Inactivated Influenza Vaccine
IL- 8
|
14.7 pg/mL
Standard Deviation 7.7
|
11.7 pg/mL
Standard Deviation 5.5
|
13.4 pg/mL
Standard Deviation 6.9
|
|
Levels of Cytokine Interleukin 8 (IL-8) Cytokine Response to Inactivated Influenza Vaccine
IL-8
|
10.4 pg/mL
Standard Deviation 6.1
|
11.9 pg/mL
Standard Deviation 4.6
|
10.2 pg/mL
Standard Deviation 4.1
|
PRIMARY outcome
Timeframe: 0 hours, 16 hours, 24 hours, 14 daysPopulation: Data for Cohort 1 reported as 0 hours and 24 hours. Data for Cohort 2 reported as 0 hours and 16 hours. Data was combined for the Cohorts and reported as 0 hours (baseline) and 14 days.
This was an exploratory trial to look at the kinetics of early (1st 48 hours) cytokine response to influenza vaccine. Serum collected was assessed for cytokines, and PBMCs may be assessed for innate and adaptive immune responses, as well as for genetic markers associated with immune responses to vaccination. Data for Cohort 1 reported as 0 hours and 24 hours. Data for Cohort 2 reported as 0 hours and 16 hours. Data was combined for the Cohorts and reported as 0 hours (baseline) and 14 days.
Outcome measures
| Measure |
Cohort 1
n=10 Participants
Cytokine Results 0 hours and 24 hours
|
Cohort 2
n=10 Participants
Cytokine results 0hours and 16 hours
|
Cohort 1 & 2
n=20 Participants
Combined Cytokine results 0 hours and 14 days
|
|---|---|---|---|
|
Levels of Cytokine Interferon Induced Gamma Protein (IP-10) Responses to Inactivated Influenza Vaccine
IP-10
|
115 pg/mL
Standard Deviation 74
|
149 pg/mL
Standard Deviation 194
|
123 pg/mL
Standard Deviation 146
|
|
Levels of Cytokine Interferon Induced Gamma Protein (IP-10) Responses to Inactivated Influenza Vaccine
IP- 10
|
488 pg/mL
Standard Deviation 365
|
292 pg/mL
Standard Deviation 309
|
127 pg/mL
Standard Deviation 71
|
Adverse Events
Cohort 1
Cohort 2
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1
n=10 participants at risk
Received vaccine in the morning
|
Cohort 2
n=10 participants at risk
Received vaccine in the evening
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
60.0%
6/10 • Number of events 6 • 14 days
|
40.0%
4/10 • Number of events 4 • 14 days
|
|
Injury, poisoning and procedural complications
Injection site pain
|
40.0%
4/10 • Number of events 4 • 14 days
|
40.0%
4/10 • Number of events 4 • 14 days
|
|
Immune system disorders
Diaphoresis
|
10.0%
1/10 • Number of events 2 • 14 days
|
0.00%
0/10 • 14 days
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
10.0%
1/10 • Number of events 1 • 14 days
|
0.00%
0/10 • 14 days
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Number of events 1 • 14 days
|
0.00%
0/10 • 14 days
|
|
Skin and subcutaneous tissue disorders
Injection site swelling
|
10.0%
1/10 • Number of events 1 • 14 days
|
10.0%
1/10 • Number of events 1 • 14 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place