التفاصيل البيبلوغرافية
| العنوان: |
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 (HVTN204). |
| المؤلفون: |
Churchyard, Gavin J., Morgan, Cecilia, Adams, Elizabeth, Hural, John, Graham, Barney S., Moodie, Zoe, Grove, Doug, Gray, Glenda, Bekker, Linda-Gail, McElrath, M. Juliana, Tomaras, Georgia D., Goepfert, Paul, Kalams, Spyros, Baden, Lindsey R., Lally, Michelle, Dolin, Raphael, Blattner, William, Kalichman, Artur, Figueroa, J. Peter, Pape, Jean |
| المصدر: |
PLoS ONE; 2011, Vol. 6 Issue 8, p1-14, 14p |
| مصطلحات موضوعية: |
VACCINES, CLINICAL trials, MEDICAL statistics, ADENOVIRUS diseases, SEROTYPES |
| مصطلحات جغرافية: |
SOUTH Africa, UNITED States, LATIN America |
| مستخلص: |
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 IM by Biojector) at 0, 1 and 2 months, followed by rAd5 (1010 PU IM 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-&ggr;(IFN-&ggr;) 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 seronegative 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 [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
Complementary Index |
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