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.
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.
Gorse
Geoffrey J
GJ
Department of Veterans Affairs Medical Center and Saint Louis University, St. Louis, MO 63104, United States. gorsegj@slu.edu <gorsegj@slu.edu>
Baden
Lindsey R
LR
Wecker
Margaret
M
Newman
Mark J
MJ
Ferrari
Guido
G
Weinhold
Kent J
KJ
Livingston
Brian D
BD
Villafana
Tonya L
TL
Li
Hongli
H
Noonan
Elizabeth
E
Russell
Nina D
ND
D016915:AIDS Vaccines / Q000009:adverse effects* / Q000235:genetics / Q000276:immunology*; D000293:Adolescent; D000328:Adult; D002478:Cells, Cultured; D003601:Cytotoxicity Tests, Immunologic; D004311:Double-Blind Method; D018984:Epitopes, T-Lymphocyte / Q000235:genetics / Q000276:immunology*; D005260:Female; D015658:HIV Infections / Q000517:prevention & control; D015497:HIV-1 / Q000235:genetics / Q000276:immunology; D006801:Humans; D007371:Interferon-gamma / Q000096:biosynthesis; D007963:Leukocytes, Mononuclear / Q000276:immunology; D008297:Male; D010957:Plasmids / Q000008:administration & dosage; D013602:T-Lymphocytes, Cytotoxic / Q000276:immunology; D019444:Vaccines, DNA / Q000009:adverse effects* / Q000235:genetics / Q000276:immunology*
D016915:AIDS Vaccines; D018984:Epitopes, T-Lymphocyte; D019444:Vaccines, DNA; D007371:Interferon-gamma