The study will be designed as a prospective surveillance of the immune response to seasonal influenza vaccination in 240 healthy children and adults ages 9 and over. Study duration will be 5 years, with a participant duration of 6 months. Subjects will receive a quadrivalent inactivated influenza vaccine, at a dose of not less than 15 ug of hemagglutinin (HA), by intramuscular injection in open label fashion on day 0. Blood draws will occur at baseline, day 7, 28 and 90. The primary objective of this study is to evaluate the relationship between first influenza A virus exposure (inferred by age), vaccine history, and baseline serum antibody response to seasonal influenza vaccine in healthy adults and children.
The study will be designed as a prospective surveillance of the immune response to seasonal influenza vaccination in 240 healthy children and adults ages 9 and over. Study duration will be 5 years, with a participant duration of 6 months. Subjects will receive a quadrivalent inactivated influenza vaccine, at a dose of not less than 15 ug of hemagglutinin (HA), by intramuscular injection in open label fashion on day 0. Blood draws will occur at baseline, day 7, 28 and 90. The primary hypothesis being tested in this study is that there will be differences in the specificity and magnitude of the HA-specific B cell response depending on the age, previous vaccine history and baseline B cell reactivity. The primary objective of this study is to evaluate the relationship between first influenza A virus exposure (inferred by age), vaccine history, and baseline serum antibody response to seasonal influenza vaccine in healthy adults and children. The secondary objective is to evaluate factors related to failure of vaccine to provide protection against symptomatic influenza and the immune response to infection in vaccinated individuals by prospective surveillance of the vaccine cohort.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
152
A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes and 2 influenza B subtypes: A/Singapore/GP1908/2015 (H1N1) IVR-180 (an A/Michigan/45/2015 \[H1N1\] pdm09-like virus), A/Singapore/INFIMH-16-0019/2016 (H3N2) IVR-186, B/Maryland/15/2016 NYMC BX-69A, (a B/Colorado/06/2017-like virus), and B/Phuket/3073/2013.
A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes and 2 influenza B subtypes: A/Singapore/GP1908/2015 (H1N1) IVR-180 (an A/Michigan/45/2015 \[H1N1\] pdm09-like virus), A/Singapore/INFIMH-16-0019/2016 (H3N2) NIB-104, B/Maryland/15/2016 NYMC BX-69A (a B/Colorado/06/2017-like virus), and B/Phuket/3073/2013.
Rochester General Hospital - Infectious Disease Unit
Rochester, New York, United States
University of Rochester Medical Center - Strong Memorial Hospital - Infectious Diseases
Rochester, New York, United States
Magnitude of the Serum Antibody Response by Hemagglutination-inhibition (HAI)
A/Hong Kong/4801/2014 (H3N2) day 28 Season 2017-2018
Time frame: Through Day 28
Magnitude of the Serum Antibody Response by Microneutralization (MN)
A/Hong Kong/4801/2014 (H3N2) Day 28 MN Season 2017-2018
Time frame: Day 28
Serum Antibody Response by Hemagglutination-inhibition (HAI)
A/Hong Kong/4801/2014 (H3N2) Day 90 Season 2017-2018
Time frame: Day 90
Serum Antibody Response by Microneutralization (MN)
A/Hong Kong/4801/2014 (H3N2) Day 90 MN Season 2017-2018
Time frame: Day 90
Specificity of the Serum Antibody Response by Hemagglutination-inhibition (HAI)
A/H1N1/Michigan/45/2015 pdm09 Day 28 Season 2017-2018
Time frame: Day 28
Specificity of the Serum Antibody Response by Microneutralization (MN)
A/H1N1/Michigan/45/2015 pdm09 Day 28 Season 2017-18
Time frame: Day 28
Age Group Stratified by Influenza Infection Status
Comparison between groups: subjects who develop symptomatic influenza (Vaccine Failures) vs. subjects who do not
Time frame: Baseline
Sex Stratified by Influenza Infection Status
Comparison between groups: subjects who develop symptomatic influenza (Vaccine Failures) vs. subjects who do not
Time frame: Baseline
Ethnicity Stratified by Influenza Infection Status
Comparison between groups: subjects who develop symptomatic influenza (Vaccine Failures) vs. subjects who do not
Time frame: Baseline
Race Stratified by Influenza Infection Status
Comparison between groups: subjects who develop symptomatic influenza (Vaccine Failures) vs. subjects who do not
Time frame: Baseline
Immune Response to the H1N1/Michigan/45/2015H1N1)pdm09 by Hemagglutination-inhibition (HAI) to Vaccination Stratified by Influenza Infection Status
Comparison between groups: subjects who develop symptomatic influenza (Vaccine Failures) vs. subjects who do not. This is an HAI immune response to the H1N1/Michigan/45/2015H1N1)pdm09 antigen.
Time frame: Day 28 and Day 90
Immune Response to the A/Hong Kong/4801/2014 (H3N2) by Hemagglutination-inhibition (HAI) to Vaccination Stratified by Influenza Infection Status
Comparison between groups: subjects who develop symptomatic influenza (Vaccine Failures) vs. subjects who do not. This is an HAI immune response to the A/Hong Kong/4801/2014 (H3N2) antigen.
Time frame: Day 28 and Day 90
Immune Response to the H1N1/Michigan/45/2015H1N1)pdm09 by Microneutralization (MN) to Vaccination Stratified by Influenza Infection Status
Comparison between groups: subjects who develop symptomatic influenza (Vaccine Failures) vs. subjects who do not. This is an MN immune response to the H1N1/Michigan/45/2015H1N1)pdm09 antigen.
Time frame: Day 28 and Day 90
Immune Response to the A/Hong Kong/4801/2014 (H3N2) by Microneutralization (MN) to Vaccination Stratified by Influenza Infection Status
Comparison between groups: subjects who develop symptomatic influenza (Vaccine Failures) vs. subjects who do not. This is an MN immune response to the A/Hong Kong/4801/2014 (H3N2) antigen.
Time frame: Day 28 and Day 90
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