Influenza Clinical Trial
Official title:
Phase I Inpatient Study of the Safety and Immunogenicity of Live Influenza A Vaccine Modified H5N1 (6-2) AA ca Recombinant (A/Hong Kong/213/2003 x A/AnnArbor/6/60 ca), a Live Attenuated Virus Vaccine Candidate for Prevention of Avian Influenza H5N1 Infection in the Event of a Pandemic
Over the past decade, avian influenza (AI) has become a major health concern. The development of a safe and effective vaccine against H5N1 infection is important. The purpose of this study is to determine the safety of a new AI vaccine in healthy adults.
According to the World Health Organization, the current pandemic risk associated with avian
influenza H5N1 infection is serious, as an increasing number of humans are infected.
Currently, H5N1 influenza transmission 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 among 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 A1 virus vaccine, H5N1 (6-2) AA ca Recombinant (A/Hong
Kong/213/2003 x A/AnnArbor/6/60 ca).
This study will last approximately 16 weeks. Participation in this study includes a hospital
stay 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 will occur daily following each
vaccination until discharge. Participants will not be discharged until nasal washes are
negative. Vital signs measurement will be done at least twice daily for the duration of the
inpatient stay. A follow-up outpatient visit will occur approximately 4 weeks following each
vaccination. Blood and urine collection will occur at selected timepoints throughout the
study.
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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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