Safety and immunogenicity of cytotoxic T-lymphocyte poly-epitope, DNA plasmid (EP HIV-1090) vaccine in healthy, human immunodeficiency virus type 1 (HIV-1)-uninfected adults.

Geoffrey J Gorse, Lindsey R Baden, Margaret Wecker, Mark J Newman, Guido Ferrari, Kent J Weinhold, Brian D Livingston, Tonya L Villafana, Hongli Li, Elizabeth Noonan, Nina D Russell

Journal: Vaccine 2008;26(2):215-23

PMID: 18055072

Full Text on Elsevier Science View on PubMed

Abstract

We evaluated EP HIV-1090 vaccine, a DNA plasmid encoding 21 cytotoxic T-lymphocyte (CTL) epitopes of human immunodeficiency virus type 1 (HIV-1) and the pan-DR helper T-lymphocyte epitope (PADRE), in a dose escalation, randomized, double-blinded, placebo-controlled Phase 1 trial. Vaccine, at 0.5, 2.0, or 4.0mg doses, or placebo was injected four times over 6 months. Forty-two healthy, HIV-1-uninfected adults were enrolled. Using an interferon-gamma ELISPOT assay, a response to PADRE was detected in one vaccine recipient. Three vaccine recipients raised anti-HIV-1 CD8+ CTL measured by chromium-release assay. The vaccine was safe and well-tolerated, but only weakly immunogenic.

Address: Department of Veterans Affairs Medical Center and Saint Louis University, St. Louis, MO 63104, United States. [email protected] <[email protected]>

DOI: 10.1016/j.vaccine.2007.10.061

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MeSH Terms: AIDS Vaccines, Adolescent, Adult, Cells, Cultured, Cytotoxicity Tests, Immunologic, Double-Blind Method, Epitopes, T-Lymphocyte, Female, HIV Infections, HIV-1, Humans, Interferon-gamma, Leukocytes, Mononuclear, Male, Plasmids, T-Lymphocytes, Cytotoxic, Vaccines, DNA