Influenza Clinical Trial
Official title:
Adaptive and Innate Immunity, Memory and Repertoire in Vaccination and Infection
The purpose of the study is to get a better understanding of the natural and adaptive immune response to the flu virus and to compare the immune cell responses to FDA-licensed flu vaccines in nasal mucosal cells and in blood.
This is a study of healthy children and adults receive the current seasonal influenza
vaccine. The volunteers were enrolled into one of 7 groups over a 5-year period. Immunization
is administered; blood samples and NP swabs are collected at various time points based on
groups assigned.
Group A (LAIV4/annual return): Up to six 2-4 year old volunteers are given a quadrivalent
live, attenuated influenza vaccine (LAIV4). All participants in this group are asked to
return annually for flu immunization and blood samples on Day 0 and Day 7 post immunization.
Vaccine naive children returned 30 days later for a second immunization per standard of care.
This group was discontinued in year 3 due to Advisory Committee on Immunization Practices
(ACIP) recommendations against the use of LAIV.
Group B (LAIV4/ single year): Up to twenty 2-4 year old volunteers were given a quadrivalent
live, attenuated influenza vaccine (LAIV4). Volunteers will participate for a single year.
All participants in this group were immunized on Day 0. Blood samples were taken on on Day 0
and Day 7 post immunization. Vaccine naive children returned 30 days later for a second
immunization per standard of care. This group was discontinued in year 3 due to ACIP
recommendations against the use of LAIV.
Group C (LAIV4/NP swab group): Up to twenty 2-4 year old volunteers were given a quadrivalent
live, attenuated influenza vaccine (LAIV4). Nasopharyngeal samples (NP) swabs were collected
Day 1 and 21 and 28 post immunization. No blood was collected for this group. Vaccine naive
children returned 30 days later for a second immunization per standard of care. This group
was discontinued in year 3 due to ACIP recommendations against the use of LAIV.
Group D (IIV4/annual return): Up to six 6 month-23 month old (inclusive) volunteers are given
a quadrivalent inactivated influenza vaccine (IIV4). All participants in this group are asked
to return annually for flu immunization and blood samples on Day 0 and Day 7 post
immunization. Vaccine naive children returned 30 days later for a second immunization per
standard of care.
Group E (IIV4/single year): Up to twenty 6 month-23 month old (inclusive) volunteers were
given a quadrivalent inactivated influenza vaccine (IIV4). Volunteers participate for a
single year. All participants in this group were immunized on Day 0. Blood samples were taken
on on Day 0 and Day 7 post immunization. Vaccine naive children returned 30 days later for a
second immunization per standard of care.
Group F (LAIV4/single year) Up to forty 9-13 year old (n= 20) and 18-49 year old (n= 20)
volunteers were given live, attenuated influenza vaccine (LAIV). Blood samples were collected
Days 0, 7, and 28 and NP swabs were collected Days 1 and 28. This group was discontinued in
year 3 due to ACIP recommendations against the use of LAIV.
Group G (IIV4/single year) Up to forty, 9-13 year old (n= 20) and 18-49 year old (n= 20)
volunteers were given a quadrivalent inactivated influenza vaccine (IIV4). Blood samples were
collected Day 0,7, and 28
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