دورية أكاديمية
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)
| 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) |
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| 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 |
| المصدر: | PLoS One ; http://journals.plos.org/plosoneTest |
| بيانات النشر: | Public Library of Science University of Cape Town Faculty of Health Sciences Desmond Tutu HIV Centre |
| سنة النشر: | 2011 |
| المجموعة: | University of Cape Town: OpenUCT |
| مصطلحات موضوعية: | T cells, Vaccines, Cytotoxic T cells, Enzyme-linked immunoassays, Antibodies, Antibody response, Cytokines, HIV-1 |
| الوصف: | 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 (10 10 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-γ (IFN-γ) 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. Trial Registration: ClinicalTrials.gov NCT00125970 |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | English |
| العلاقة: | http://hdl.handle.net/11427/15280Test; http://dx.doi.org/10.1371/journal.pone.0021225Test; https://open.uct.ac.za/bitstream/11427/15280/1/Churchyard_phase_IIA_randomized_clinical_trial_2011.pdfTest |
| DOI: | 10.1371/journal.pone.0021225 |
| الإتاحة: | https://doi.org/10.1371/journal.pone.0021225Test http://hdl.handle.net/11427/15280Test https://open.uct.ac.za/bitstream/11427/15280/1/Churchyard_phase_IIA_randomized_clinical_trial_2011.pdfTest |
| حقوق: | This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. ; http://creativecommons.org/licenses/by/4.0Test ; © 2011 Churchyard et al |
| رقم الانضمام: | edsbas.665C15 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1371/journal.pone.0021225 |
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