Trial Outcomes & Findings for The Immunologic Basis for an Attenuated Immune Response to the Influenza Vaccine After Repeated Annual Vaccination (NCT NCT02876159)
NCT ID: NCT02876159
Last Updated: 2018-12-12
Results Overview
Geometric mean serum HAI antibody titers serum HAI titer will be collected via blood draw. Titer for serum HAI antibodies will be calculated using the geometric mean. Change is defined as the difference in means from Day 1 to Day 29.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
Baseline (Day 1), Day 29
Results posted on
2018-12-12
Participant Flow
Participants for this study were enrolled from 07/01/2016 to 09/30/2016. Clinical study was conducted at Hope Clinic of Emory University.
Participant milestones
| Measure |
Vaccination Naïve
Participants who have received an influenza vaccine in 2 or less of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.
2016-2017 Influenza Vaccine: Quadrivalent influenza A/H1N1, A/H3N2, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.
|
Vaccination Experienced
Participants who have received an influenza vaccine at least 3 of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.
2016-2017 Influenza Vaccine: Quadrivalent influenza A/H1N1, A/H3N2, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Immunologic Basis for an Attenuated Immune Response to the Influenza Vaccine After Repeated Annual Vaccination
Baseline characteristics by cohort
| Measure |
Vaccination Naïve
n=10 Participants
Participants who have received an influenza vaccine in 2 or less of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.
2016-2017 Influenza Vaccine: Quadrivalent influenza A/H1N1, A/H3N2, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.
|
Vaccination Experienced
n=10 Participants
Participants who have received an influenza vaccine at least 3 of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.
2016-2017 Influenza Vaccine: Quadrivalent influenza A/H1N1, A/H3N2, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
23.4 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
24.6 years
STANDARD_DEVIATION 2.2 • n=7 Participants
|
24.0 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
|
BMI
|
25.7 kg/m^2
STANDARD_DEVIATION 8 • n=5 Participants
|
22.8 kg/m^2
STANDARD_DEVIATION 2.77 • n=7 Participants
|
24.3 kg/m^2
STANDARD_DEVIATION 5.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1), Day 29Geometric mean serum HAI antibody titers serum HAI titer will be collected via blood draw. Titer for serum HAI antibodies will be calculated using the geometric mean. Change is defined as the difference in means from Day 1 to Day 29.
Outcome measures
| Measure |
Vaccination Naïve
n=10 Participants
Participants who have received an influenza vaccine in 2 or less of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.
2016-2017 Influenza Vaccine: Quadrivalent influenza A/Hemagglutinin Type 1 (H1N1), A/Influenza A virus subtype (H3N2), B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.
|
Vaccination Experienced
n=10 Participants
Participants who have received an influenza vaccine at least 3 of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.
2016-2017 Influenza Vaccine: Quadrivalent influenza A/Hemagglutinin Type 1 (H1N1)/ Influenza A virus subtype H3N2, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.
|
|---|---|---|
|
Change in Geometric Mean Serum Hemagglutination Inhibition (HAI) Antibody Titer
Day 1
|
23 HAI antibody Titers
Standard Deviation 19.9
|
56.5 HAI antibody Titers
Standard Deviation 95.7
|
|
Change in Geometric Mean Serum Hemagglutination Inhibition (HAI) Antibody Titer
Day 29
|
188 HAI antibody Titers
Standard Deviation 191.4
|
108 HAI antibody Titers
Standard Deviation 89
|
PRIMARY outcome
Timeframe: Up to 15 DaysTFH cells will be collected via blood draw. Change is defined as the difference in the mean levels of cells from baseline, day 8, and day 15.
Outcome measures
| Measure |
Vaccination Naïve
n=10 Participants
Participants who have received an influenza vaccine in 2 or less of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.
2016-2017 Influenza Vaccine: Quadrivalent influenza A/Hemagglutinin Type 1 (H1N1), A/Influenza A virus subtype (H3N2), B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.
|
Vaccination Experienced
n=10 Participants
Participants who have received an influenza vaccine at least 3 of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.
2016-2017 Influenza Vaccine: Quadrivalent influenza A/Hemagglutinin Type 1 (H1N1)/ Influenza A virus subtype H3N2, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.
|
|---|---|---|
|
Change in Mean Level of Circulating Follicular Helper T (TFH) Cells
Day 1
|
1.9 cells/mm^3
Standard Deviation 1
|
1.4 cells/mm^3
Standard Deviation 0.8
|
|
Change in Mean Level of Circulating Follicular Helper T (TFH) Cells
Day 8
|
13.8 cells/mm^3
Standard Deviation 11.4
|
2.96 cells/mm^3
Standard Deviation 1.8
|
|
Change in Mean Level of Circulating Follicular Helper T (TFH) Cells
Day 15
|
4.1 cells/mm^3
Standard Deviation 2.3
|
2.5 cells/mm^3
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: Up to 29 DaysPlasmablasts will be collected via blood draw. Change is defined as the difference in mean levels from baseline to Day 29.
Outcome measures
| Measure |
Vaccination Naïve
n=10 Participants
Participants who have received an influenza vaccine in 2 or less of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.
2016-2017 Influenza Vaccine: Quadrivalent influenza A/Hemagglutinin Type 1 (H1N1), A/Influenza A virus subtype (H3N2), B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.
|
Vaccination Experienced
n=10 Participants
Participants who have received an influenza vaccine at least 3 of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.
2016-2017 Influenza Vaccine: Quadrivalent influenza A/Hemagglutinin Type 1 (H1N1)/ Influenza A virus subtype H3N2, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.
|
|---|---|---|
|
Change in Mean Levels of Plasmablasts
Day 1
|
2.5 cells/mm^3
Standard Deviation 2.3
|
0.9 cells/mm^3
Standard Deviation 0.7
|
|
Change in Mean Levels of Plasmablasts
Day 8
|
6.7 cells/mm^3
Standard Deviation 5.1
|
0.5 cells/mm^3
Standard Deviation 0.3
|
|
Change in Mean Levels of Plasmablasts
Day 15
|
2.3 cells/mm^3
Standard Deviation 3.0
|
0.6 cells/mm^3
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Day 29Population: only 9 participant samples were analyzed as 1 sample could not be analyzed
Memory B cells will be collected via blood draw. Change is defined as the difference in mean levels from baseline to Day 29.
Outcome measures
| Measure |
Vaccination Naïve
n=9 Participants
Participants who have received an influenza vaccine in 2 or less of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.
2016-2017 Influenza Vaccine: Quadrivalent influenza A/Hemagglutinin Type 1 (H1N1), A/Influenza A virus subtype (H3N2), B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.
|
Vaccination Experienced
n=9 Participants
Participants who have received an influenza vaccine at least 3 of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.
2016-2017 Influenza Vaccine: Quadrivalent influenza A/Hemagglutinin Type 1 (H1N1)/ Influenza A virus subtype H3N2, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.
|
|---|---|---|
|
Change in Mean Levels of Memory B Cells From Baseline (Day 1) to Day 29
Day 1
|
0.18 cells/mm^3
Standard Deviation 0.22
|
0.46 cells/mm^3
Standard Deviation 0.72
|
|
Change in Mean Levels of Memory B Cells From Baseline (Day 1) to Day 29
Day 29
|
0.71 cells/mm^3
Standard Deviation 0.77
|
0.29 cells/mm^3
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: Up to 29 DaysAntigen-specific Interleukin 2 (IL-2) producing cluster of differentiation 4 (CD4)+ T cells will be collected via blood draw. Change is defined as the difference in mean levels from baseline to Day 29.
Outcome measures
| Measure |
Vaccination Naïve
n=10 Participants
Participants who have received an influenza vaccine in 2 or less of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.
2016-2017 Influenza Vaccine: Quadrivalent influenza A/Hemagglutinin Type 1 (H1N1), A/Influenza A virus subtype (H3N2), B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.
|
Vaccination Experienced
n=10 Participants
Participants who have received an influenza vaccine at least 3 of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.
2016-2017 Influenza Vaccine: Quadrivalent influenza A/Hemagglutinin Type 1 (H1N1)/ Influenza A virus subtype H3N2, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.
|
|---|---|---|
|
Change in Mean Levels of Antigen-specific IL-2 Producing CD4+ T Cells
Day 1
|
0.018 cells/mm^3
Standard Deviation 0.02
|
0.018 cells/mm^3
Standard Deviation 0.017
|
|
Change in Mean Levels of Antigen-specific IL-2 Producing CD4+ T Cells
Day 29
|
0.013 cells/mm^3
Standard Deviation 0.097
|
0.038 cells/mm^3
Standard Deviation 0.024
|
SECONDARY outcome
Timeframe: Up to 29 DaysPopulation: CD8+T cell assays were not collected since the split virus influenza vaccine was not likely to induce any detectable CD8+ T cell responses.
CD8+T cells will be collected via blood draw. Change is defined as the difference in mean levels from baseline to Day 29.
Outcome measures
Outcome data not reported
Adverse Events
Vaccination Naïve
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vaccination Experienced
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place