Healthy Clinical Trial
Official title:
Genetic and Environmental Factors in the Response to Influenza Vaccination
The purpose of the study is to investigate and compare the immune responses to influenza vaccination in monozygotic (identical) and dizygotic (fraternal) twins to determine the roles of genetics and environment in the response to flu vaccination.
This is a phase 1 study of 120 healthy 12-49 year old adolescents and adult volunteers who
are given licensed seasonal influenza vaccine. There are no exclusions for gender, ethnicity
or race. The volunteers will be enrolled into one of 3 groups:
Group A: Up to 40 healthy monozygotic (MZ) twin volunteers, 12-49 years old, will be given
inactivated influenza vaccine quadrivalent (IIV4). Each volunteer will complete a total of 3
visits: Day 0 (pre-immunization), Day 6-8 and Day 28+ 7 post-immunization. All visits will
consist of drawing blood for study assays and monitoring for serious adverse events (SAEs).
Group B: Up to 40 healthy dizygotic (DZ) twin volunteers, 12-49 years old, will be given
inactivated influenza vaccine quadrivalent (IIV4). Each volunteer will complete a total of 3
visits: Day 0 (pre-immunization), Day 6-8 and Day 28+7 post-immunization. All visits will
consist of drawing blood for study assays and monitoring for serious adverse events (SAEs).
Group C: Up to 40 healthy monozygotic (MZ) twin volunteers, 12-49 years old, will be
randomized within the twin pair to receive either inactivated influenza vaccine quadrivalent
(IIV4) or live, attenuated influenza vaccine quadrivalent (LAIV4). Each volunteer will
complete a total of 3 visits: Day 0 (pre-immunization), Day 6-8 and Day 28+7
post-immunization. All visits will consist of drawing blood for study assays and monitoring
for serious adverse events (SAEs). This group was terminated in 2016 due to ACIP
recommendations against the use of LAIV but was reopened in 2018 with the availability of
LAIV4.
Each twin is counted as a single participant. All reporting numbers reflect the number of
participants, not the number of twin pairs.
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