Safety and immunogenicity of a CTL multiepitope peptide vaccine for HIV with or without GM-CSF in a phase I trial.

Journal Article (Journal Article;Multicenter Study)

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 multiepitope peptide vaccine to elicit HIV-specific immunity. To enhance the immunogenicity of the peptide vaccine, half of the vaccine recipients received recombinant granulocyte-macrophage colony stimulating factor (GM-CSF) protein as a coadjuvant. 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.

Full Text

Duke Authors

Cited Authors

  • Spearman, P; Kalams, S; Elizaga, M; Metch, B; Chiu, Y-L; 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,

Published Date

  • January 7, 2009

Published In

Volume / Issue

  • 27 / 2

Start / End Page

  • 243 - 249

PubMed ID

  • 18996425

Pubmed Central ID

  • PMC2692338

International Standard Serial Number (ISSN)

  • 0264-410X

Digital Object Identifier (DOI)

  • 10.1016/j.vaccine.2008.10.051


  • eng

Conference Location

  • Netherlands