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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
immunology and microbiology
Safety and immunogenicity of the MRKAd5 gag HIV type 1 vaccine in a worldwide phase 1 study of healthy adults
AIDS Research and Human Retroviruses, Volume 27, No. 5, Year 2011
Notification
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Description
The safety and immunogenicity of the MRK adenovirus type 5 (Ad5) HIV-1 clade B gag vaccine was assessed in an international Phase I trial. Three-hundred and sixty healthy HIV-uninfected adults were enrolled on five continents. Subjects received placebo or 1 × 109 or 1 × 1010 viral particles (vp) per dose of the MRKAd5 HIV-1 gag vaccine at day 1, week 4, and week 26. Immunogenicity was evaluated using an IFN-γ ELISPOT gag 15-mer assay with positive responses defined as ≥55 SFC/10 6 PBMCs and ≥4-fold over mock control. The vaccine was well tolerated. The most common adverse events were injection site reactions, headache, pyrexia, diarrhea, fatigue, and myalgia. At week 30, geometric mean ELISPOT responses were 24, 114, and 226 SFC/106 PBMCs in the placebo, 1 × 109 vp/dose, and 1 × 1010 vp/dose groups, respectively. Overall, responses to 1 × 1010 vp were 85% and 68% in subjects with low (≤200) and high (>200) baseline Ad5 titers, respectively. The MRKAd5 HIV-1 gag vaccine was immunogenic in diverse geographic regions. Gag ELISPOT responses were greater in the 1 × 1010 vp/dose groups than in the 1 × 109 vp/dose groups. Data from this first international study indicate that adenovirus-vectored vaccines are well tolerated and may be immunogenic in subjects from regions with high prevalence of preexisting Ad5 immunity. © Copyright 2011, Mary Ann Liebert, Inc.
Authors & Co-Authors
Nicholson, Ouzama
Unknown Affiliation
Dicandilo, Fay
Unknown Affiliation
Kublin, James G.
Unknown Affiliation
Sun, Xiao
Unknown Affiliation
Quirk, Erin
Unknown Affiliation
Miller, Michelle
Unknown Affiliation
Gray, Glenda E.
Unknown Affiliation
Pape, Jean William
Unknown Affiliation
Robertson, Michael N.
Unknown Affiliation
Mehrotra, Devan V.
Unknown Affiliation
Self, Steven G.
Unknown Affiliation
Turner, Katherine
Unknown Affiliation
Sánchez, Jorge L.
Unknown Affiliation
Pitisuttithum, Punnee
Unknown Affiliation
Duerr, Ann C.
Unknown Affiliation
Dubey, Sheri A.
Unknown Affiliation
Kierstead, Lisa
Unknown Affiliation
Casimiro, Danilo R.
Unknown Affiliation
Hammer, Scott M.
Unknown Affiliation
Statistics
Citations: 19
Authors: 19
Affiliations: 11
Identifiers
Doi:
10.1089/aid.2010.0151
ISSN:
08892229
Research Areas
Infectious Diseases
Study Design
Cross Sectional Study