Influenza Clinical Trial
Official title:
Phase I Inpatient Study of the Safety and Immunogenicity of Live Influenza A Vaccine H2N2 (A/Ann Arbor/6/60 ca Recombinant), a Live Attenuated Virus Vaccine Candidate for Prevention of Influenza H2N2 Infection in the Event of a Pandemic
In the 20th century, influenza pandemics occurred in 1918, 1957, and 1968, and were associated with significant morbidity and mortality. It is estimated that, in the United States alone, the next influenza pandemic could cause approximately 200,000 deaths and 750,000 hospitalizations. Thus, the development of a vaccine against potential influenza strains has become a priority. The purpose of this study is to determine the safety and immune response to an H2N2 influenza vaccine candidate.
H2N2 influenza viruses emerged in the 1950s replacing the then circulating H1N1 human
influenza virus. The first cases occurred in China in 1956, and disease became widespread in
1956-1957, resulting in the "Asian Influenza" pandemic that was responsible for between 1
and 4 million deaths worldwide. H2N2 viruses have not circulated since 1968, when they were
replaced by H3N2 influenza viruses and the resurgence of H1N1 viruses. For this reason, a
large proportion of the population is now susceptible to infection with H2N2 influenza. If
this subtype re-emerges, it could potentially cause the next pandemic. This vaccine,
therefore, is an important priority in the development of vaccines against potential
pandemic influenza strains.
This vaccine trial will be conducted in the Center for Immunization Research isolation unit
in the Mason F. Lord Building at the Johns Hopkins Bayview Medical Center (Baltimore, MD).
The study will be initiated between April 1st and December 20th, 2008, when wild-type
influenza is unlikely to be circulating in the Baltimore area.
An individual's participation in the study will last approximately 90 days. All participants
will receive two vaccinations approximately 4 - 8 weeks apart. After each vaccination,
participants will remain in isolation at the study site for at least nine days or until
rRT-PCR assays for influenza are negative for 2 consecutive days. A physical examination and
nasal wash will occur each day during the isolation period. Blood collection will occur in
isolation beginning on Day 7 until release. Follow-up outpatient visits are scheduled on
Days 28 and 56 after the first vaccination and on Day 28 after the second vaccination.
Follow-up visits will include serum collection, nasal wash, and interim medical history.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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