期刊
VACCINE
卷 26, 期 22, 页码 2788-2795出版社
ELSEVIER SCI LTD
DOI: 10.1016/j.vaccine.2008.02.071
关键词
HIV-AIDS vaccine; phase 1 clinical trials; East Africa; DNA vaccine; recombinant MVA vaccine
资金
- Medical Research Council [MC_U137884177, MC_U137884179, MC_U950097145] Funding Source: researchfish
- Medical Research Council [MC_U137884177, MC_U137884179, MC_U950097145] Funding Source: Medline
- MRC [MC_U137884177, MC_U137884179] Funding Source: UKRI
The safety and immunogenicity of plasmid pTHr DNA, modified vaccinia virus Ankara (MVA) human immunodeficiency virus type 1 (HIV-1) vaccine candidates were evaluated in four Phase I clinical trials in Kenya and Uganda. Both vaccines, expressing HIV-1 subtype A gag p24/p17 and a string of CD8 T-cell epitopes (HIVA), were generally safe and well-tolerated. At the dosage levels and intervals tested, the percentage of vaccine recipients with HIV-1-specific cell-mediated immune responses, assessed by a validated ex vivo interferon gamma (IFN-gamma) ELISPOT assay and Cytokine Flow Cytometry (CFC), did not significantly differ from placebo recipients. These trials demonstrated the feasibility of conducting high-quality Phase 1 trials in Africa. (C) 2008 Elsevier Ltd. All rights reserved.
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