Influenza Clinical Trial
Official title:
Systems Biology of Trivalent Influenza Vaccine (TIV) in Young and Elderly
Vaccination is the most effective way of preventing infectious diseases. Despite the success
of vaccines in general, vaccines induce diminished antibody responses and lower protection in
the elderly in particular. This could be explained by a defect in the early responses of an
ageing immune system. A better understanding of the basic immunological mechanisms that
mediate vaccine efficacy is incomplete. Such information is critical and could greatly
decrease both the cost and the time to new vaccine development particularly for the geriatric
population.
In this trial, the investigators will study the immunologic differences of an FDA approved
licensed influenza vaccine between a younger and an older group. Twenty two healthy
volunteers between the age of 25-40 and forty four healthy volunteers above the age of 65
will be enrolled in the study. Each participant in the study will be given one flu shot.
Blood work will be obtained prior to vaccination, one day, three days, seven days, fourteen
days, as well as one month and six months after vaccination. Throughout the duration of the
study, the participants will be monitored for safety.
RATIONALE:Trivalent Influenza vaccine (TIV) is known to induce diminished functional antibody
responses and lower protection in the elderly. Here we hypothesize that this is due to
intrinsic defects in innate responses which translates into suboptimal Hemagglutination
Inhibition Assay (HAI) titers. Therefore, early innate signatures of vaccination should
correlate with, and predict the immunogenicity of TIV in the young and elderly.
STUDY DESIGN: Single center, open label study in which adult healthy volunteers with no
contraindications to immunization will be vaccinated with TIV. Blood samples will be
collected on Days D0 (at enrollment) and D1, D3, D7, D14, D30, D180 post vaccination to study
innate and/or adaptive immunity markers. Even though influenza vaccination is considered
safe, volunteers will be asked to report any local or systemic adverse events (AEs) from Day
0 (vaccination) to Day 7 in memory aids. Reactogenicity events will also be evaluated by
injection site examination on visits at D0, D1, D3 and D7. Volunteers will be also asked to
report local and systemic AEs developing the day of a blood draw.
Additionally, only AEs considered related (unlikely, possibly, probably or definitely
related) will be collected and reported in this study from Day 0 (vaccination) to Day 180.
After Day 30 only related SAEs will be collected and reported.
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