Influenza Clinical Trial
Official title:
Phase 1 Inpatient Study of the Safety and Immunogenicity of Live Influenza A Vaccine H5N1 (6-2) AA ca Recombinant (A/VietNam/1203/2004 x A/AnnArbor/6/60/ca), a Live Attenuated Virus Vaccine Candidate for the Prevention of Avian Influenza H5N1 Infection in the Event of a Pandemic
Avian influenza (AI), or bird flu, has recently become a major health concern in Asia and other parts of the world. The need for a vaccine to prevent the spread of AI among livestock and to humans is sorely needed. The purpose of this study is to test the safety of and immune response to a new AI vaccine in healthy adults.
AI viruses in their natural reservoir in waterfowl are the source from which novel HA and NA
subtypes are introduced into the human population, and have the potential to initiate an
influenza pandemic. This study will evaluate the safety and immunogenicity of a live,
attenuated recombinant AI virus vaccine, H5N1 (6-2) AA Ca Recombinant (A/VietNam/1203/2004 x
A/AnnArbor/6/60/Ca).
Participants in this study will receive one or two doses of the vaccine. There are 3 groups
in this study:
- Group 1 will receive two vaccinations at the highest dose.
- Group 2 will receive one vaccination at a dose in-between the lowest and highest doses.
- Group 3 will receive one vaccination at the lowest dose.
Group 1 will enroll first, probably in 2006. Groups 2 and 3 will not enroll until it is
determined by safety review that the vaccine is well-tolerated and greater than 80% of Group
1 participants shed vaccine virus or develop a specific immune response to the vaccine.
Participation in this study includes a hospital stay in an isolation unit of the Bayview
Medical Center of Johns Hopkins University. All participants will receive the vaccine at
study entry and will remain in the isolation unit for a minimum of 14 days after
vaccination. A physical exam and a nasal wash will occur daily in the isolation unit until a
participant is discharged from the hospital. Participants will be allowed to leave the unit
once viral cultures for influenza from nasal washes are negative for at least 3 consecutive
days beginning on Day 10. Blood collection will occur at study entry, Day 7, sometime
between Days 28 and 35, and sometime between Days 56 and 63.
There will be two separate hospitalizations for Group 1 participants. Group 1 participants
will receive their doses of vaccine at study entry and sometime between Days 28 and 35. A
physical exam and a nasal wash will occur daily in the isolation unit until a participant is
discharged from the hospital. Participants will be allowed to leave the unit once viral
cultures for influenza from nasal washes are negative for at least 3 consecutive days
beginning on Day 10. Blood collection will occur at 4 or 5 selected timepoints, depending on
the timing of the second vaccination.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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