A Phase 1B Open-label Clinical Trial to Expand the Characterization of the Immune Responses to the Merck Adenovirus Serotype 5 HIV-1 Gag/Pol/Nef Vaccine in Healthy, HIV-1-uninfected Adult Participants
This study will look for relationships among the immune responses induced by MRKAd5 HIV-1
gag/pol/nef vaccine. The study will also determine if the T cells that respond to different
vaccine epitopes have correspondingly different functional profiles. The study will evaluate
the safety and tolerability of the vaccine regimen as well.
This study will last 60 weeks. All enrolled participants will receive vaccinations at Weeks
0, 4, and 26. There will be between 8 and 20 study visits including the screening visit,
depending on the site location. A physical exam, interview, and blood collection will occur
at most or all visits. All participants will undergo leukapheresis approximately 4 weeks
after their last vaccination and at Week 52. Medical history, an HIV test, a pregnancy test,
and HIV and risk reduction counseling will occur at selected visits. Additional blood
collection is now occurring in this study to collect more information about the relationship
between the immune response and efficacy to the vaccine.
Note: As of 09/19/07, enrollment and vaccinations have been discontinued.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Relatedness of different immune response to vaccine
Ann Duerr, MD, PhD, MPH
HVTN Core Operations Center, Fred Hutchinson Cancer Research Center (FHCRC)
United States: Food and Drug Administration
|Alabama Vaccine CRS||Birmingham, Alabama 35294|
|Univ. of Rochester HVTN CRS||Rochester, New York 14642|
|Vanderbilt Vaccine CRS||Nashville, Tennessee 37232|
|FHCRC/UW Vaccine CRS||Seattle, Washington 98104|