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Publication Type
Journal Article
UWI Author(s)
Author, Analytic
Churchyard, GJ; Morgan, C; Adams, E; Hural, J; Graham, BS; Moodie, Z; Grove, D; Gray, G; Bekker, LG; McElrath, MJ; Tomaras, GD; Goepfert, P; Kalams, S; Baden, LR; Lally, M; Dolin, R; Blattner, W; Kalichman, A; Figueroa, J.Peter; Pape, J, Schechter, M; Defawe, O; De Rosa, SC; Montefiori, DC; Nabel, GJ; Corey, L; Keefer, MC; NIAID HIV Vaccine Trials Network. (HVTN204)....
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Author Affiliation, Ana.
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Article Title
A Phase IIA Randomized Clinical Trial of a Multiclade HIV-1 DNA Prime Followed by a Multiclade rAd5 HIV-1 Vaccine Boost in Healthy Adults
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Journal Title
PLoS One
Translated Title
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Reprint Status
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Date of Publication
2011 August 3
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Location/URL
https:; www.ncbi.nlm.nih.gov/pubmed/21857901
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Abstract
BACKGROUND: The safety and immunogenicity of a vaccine regimen consisting of a 6-plasmid HIV-1 DNA prime (envA, envB, envC, gagB, polB, nefB) boosted by a recombinant adenovirus serotype-5 (rAd5) HIV-1 with matching inserts was evaluated in HIV-seronegative participants from South Africa, United States, Latin America and the Caribbean. METHODS: 480 participants were evenly randomized to receive either: DNA (4 mg i.m. by Biojector) at 0, 1 and 2 months, followed by rAd5 (10(10) PU i.m. by needle/syringe) at 6 months; or placebo. Participants were monitored for reactogenicity and adverse events throughout the 12-month study. Peak and duration of HIV-specific humoral and cellular immune responses were evaluated after the prime and boost. RESULTS: The vaccine was well tolerated and safe. T-cell responses, detected by interferon-? (IFN-?) ELISpot to global potential T-cell epitopes (PTEs) were observed in 70.8% (136/192) of vaccine recipients overall, most frequently to Gag (54.7%) and to Env (54.2%). In U.S. vaccine recipients T-cell responses were less frequent in Ad5 sero-positive versus sero-negative vaccine recipients (62.5% versus 85.7% respectively, p?=?0.035). The frequency of HIV-specific CD4+ and CD8+ T-cell responses detected by intracellular cytokine staining were similar (41.8% and 47.2% respectively) and most secreted =2 cytokines. The vaccine induced a high frequency (83.7%-94.6%) of binding antibody responses to consensus Group M, and Clades A, B and C gp140 Env oligomers. Antibody responses to Gag were elicited in 46% of vaccine recipients.CONCLUSION: The vaccine regimen was well-tolerated and induced polyfunctional CD4+ and CD8+ T-cells and multi-clade anti-Env binding antibodies.....
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