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

Publication Type:

Journal Article


Vaccine, Volume 27, Issue 2, p.243-9 (2009)


2009, Adjuvants, Immunologic, Adolescent, Adult, AIDS Vaccines, Amino Acid Sequence, Granulocyte Macrophage Colony-Stimulating Factors, Recombinant, HIV Infections, HIV-1, Humans, interferon-gamma, Lymphocyte Activation, Middle Aged, Molecular Sequence Data, Peptide Fragments, T-Lymphocytes, Cytotoxic, Treatment Outcome, Vaccine and Infectious Disease Institute, Vaccines, Subunit, Young Adult


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.