Safety and immunogenicity of a CTL multiepitope peptide vaccine for HIV with or without GM-CSF in a phase I trial.
Safety and immunogenicity of a CTL multiepitope peptide vaccine for HIV with or without GM-CSF in a phase I trial.
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DOI：
10.1016/j.vaccine.2008.10.051
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发表时间：
2009-01-07
期刊：
影响因子：
5.5
通讯作者：
NIAID HIV Vaccine Trials Network
中科院分区：
文献类型：
--
作者：
Spearman P;Kalams S;Elizaga M;Metch B;Chiu YL;Allen M;Weinhold KJ;Ferrari G;Parker SD;McElrath MJ;Frey SE;Fuchs JD;Keefer MC;Lubeck MD;Egan M;Braun R;Eldridge JH;Haynes BF;Corey L;NIAID HIV Vaccine Trials Network
There is an urgent need for a vaccine capable of preventing HIV infection or the development of HIV-related disease. A number of approaches designed to stimulate HIV-specific CD8+ cytotoxic T cell responses together with helper responses are presently under evaluation. In this phase 1, multi-center, placebo-controlled trial, we tested the ability of a novel multi-epitope peptide vaccine to elicit HIV-specific immunity. To enhance the immunogenicity of the peptide vaccine, half of the vaccine recipients received recombinant GM-CSF protein as a co-adjuvant. The vaccine was safe; tolerability was moderate, with a number of adverse events related to local injection site reactogenicity. Anti-GM-CSF antibody responses developed in the majority of GM-CSF recipients but were not associated with adverse hematologic events. The vaccine was only minimally immunogenic. Six of 80 volunteers who received vaccine developed HIV-specific responses as measured by interferon-gamma ELISPOT assay, and measurable responses were transient. This study failed to demonstrate that GM-CSF can substantially improve the overall weak immunogenicity of a multiepitope peptide-based HIV vaccine.
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