Influenza Clinical Trial
Official title:
Phase 1 Inpatient Study of the Safety and Immunogenicity of Live Influenza A Vaccine H7N3 (6-2) AA ca Recombinant (A/Chicken/British Columbia/CN-6/2004 x A/Ann Arbor/6/60 ca), a Live Attenuated Virus Vaccine Candidate for the Prevention of Avian Influenza H7N3 Infection in the Event of a Pandemic
Over the past decade, avian influenza (AI) has become a major health concern. The development of safe and effective vaccines against avian strains infecting people is important. The purpose of this study is to determine the safety of and immune response to a new AI vaccine in healthy adults against the H7N3 strain of avian influenza.
The current pandemic risk associated with avian influenza H7N3 infection is significant as
an increasing number of humans are infected. H7 influenza transmission usually occurs in
humans when they are exposed through direct contact to infected poultry or surfaces and
objects contaminated by infected poultry feces. A pandemic occurs when a new influenza
subtype emerges that infects humans, causes serious illness, and spreads easily between
humans. The development of a safe and effective vaccine is necessary, should a pandemic
occur. The purpose of this study is to evaluate the safety and immunogenicity of a live,
attenuated AI virus vaccine, H7N3 (6-2) AA ca Recombinant (A/chicken/British
Columbia/CN-6/2004 x A/Ann Arbor/6/60 ca).
This study will last approximately 90 days. Participation in this study includes two 12-day
hospital stays in an isolation unit at the Johns Hopkins Bayview Medical Center. All
participants will receive two doses of vaccine in nasal spray form, at study entry and
sometime between 4 and 8 weeks after initial vaccination. Participants will be admitted to
the isolation unit 2 days prior to each vaccination. A targeted physical exam, vital signs
measurement, and a nasal wash will occur daily following each vaccination until discharge.
Participants will be discharged after three consecutive nasal washes on or after Day 6 are
negative. Blood and urine collection will occur at selected timepoints throughout the study.
A follow-up outpatient visit will occur approximately 4 weeks following each vaccination.
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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