Safety of and Immune Response to a Bird Flu Virus Vaccine (H5N1) in Healthy Adults
Condition: Influenza; Virus Diseases
MeSH terms: Virus Diseases; Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): H5N1 (6-2) AA ca Recombinant (A/VietNam/1203/2004 x A/AnnArbor/6/60/ca)
Intervention type(s): Biological
Intervention description(s): Live, attenuated recombinant H5N1 (6-2) AA ca Recombinant (A/VietNam/1203/2004 x A/AnnArbor/6/60/ca) vaccine (one of three doses)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Bird Flu