Journal
AIDS RESEARCH AND HUMAN RETROVIRUSES
Volume 26, Issue 8, Pages 933-942Publisher
MARY ANN LIEBERT, INC
DOI: 10.1089/aid.2009.0242
Keywords
-
Categories
Funding
- International AIDS Vaccine Initiative (IAVI)
- Alfred P. Sloan Foundation
- Bill & Melinda Gates Foundation
- John D. Evans Foundation
- New York Community Trust
- James B. Pendleton Charitable Trust
- Rockefeller Foundation
- Starr Foundation
- William and Flora Hewlett Foundation
- Governments of Canada, Denmark, Ireland
- MRC [MC_U950097145] Funding Source: UKRI
- Medical Research Council [MC_U950097145] Funding Source: researchfish
Ask authors/readers for more resources
The recombinant vaccine, tgAAC09, based on an adeno-associated virus serotype 2 (AAV2) vector encoding HIV-1 subtype C Gag, protease, and part of reverse transcriptase, induced robust T cell and antibody responses in nonhuman primates. In a previous phase I study in 80 healthy HIV-seronegative European and Indian adults, the vaccine was generally safe, well tolerated, and modestly immunogenic when administered once at doses up to 3 x 10(11) DRP. This phase II double-blind, randomized, placebo-controlled trial tested two administrations and a higher dosage of tgAAC009. Ninety-one healthy HIV-seronegative adults from three African countries were given one of three dosage levels of tgAAC09 (3 x 10(10), 3 x 10(11), or 3 x 10(12) DRP) intramuscularly, either at a 6- or 12-month interval; follow-up was 18 months. Overall, 65% and 57% of vaccine recipients experienced local and systemic signs and symptoms, respectively, most being mild. Frequency and severity were not dose related and were similar to those in placebo recipients. No vaccine-related serious adverse events were reported. Overall, HIV-specific T cell responses were detected by IFN-gamma ELISPOT in 17/69 (25%) vaccine recipients with 38% (10/26) responders in the highest dosage group. The response rate improved significantly with boosting at 6, but not 12 months, in the 3 x 10(11) and 3 x 10(12) dosage groups only. Neutralizing antibody titers to the AAV2 did not alter the frequency of immune responses to HIV. Two doses of tgAAC09 were well tolerated at the dosage levels given. Fewer than half the recipients of the highest vaccine dosage, 3 x 10(12) DRP, had T cell responses to HIV.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available