A Phase 2 Study to Evaluate the Safety and Immunogenicity of a Recombinant HIV Type 1 Vaccine Basedon Adeno-Associated Virus.

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dc.contributor.authorVardas, Eftyhia
dc.contributor.authorKaleebu, Pontiano
dc.contributor.authorBekker, Linda-Gail
dc.contributor.authorHoosen, Anwar
dc.contributor.authorChomba, Elwyn
dc.contributor.authorJohnson, Philip R.
dc.contributor.authorAnklesaria, Pervin
dc.contributor.authorBirungi, Josephine
dc.contributor.authorBarin, Burc
dc.contributor.authorBoaz, Mark
dc.contributor.authorCox, Josephine
dc.contributor.authorLehrman, Jennifer
dc.contributor.authorStevens, Gwynn
dc.contributor.authorGilmour, Jill
dc.contributor.authorTarragona, Tony
dc.contributor.authorHayes, Peter
dc.contributor.authorLowenbein, Sarah
dc.contributor.authorKizito, Eva
dc.contributor.authorFast, Patricia
dc.contributor.authorHeald, Alison E.
dc.contributor.authorSchmidt, Claudia
dc.date.accessioned2018-07-25T06:34:41Z
dc.date.available2018-07-25T06:34:41Z
dc.date.issued2010-08-12
dc.descriptionThe study vaccine, tgAAC09, consisted of purified particles containing the single-stranded DNA from HIV-1 subtype C genes derived from the South African isolate DU422, encoding Gag-PR-DRT proteins, enclosed within a recombinant adeno-associated virus serotype 2 (AAV2) protein capsid.6 The HIV gag-pro-DRT nucleic acid is a synthetic cDNA for HIV-1 gag-protease.en_US
dc.description.abstractThe 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 3x10 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 (3x1010, 3x10 11, or 3x10 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-g 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 3x10 11 and 3x10 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, 3x10 12 DRP, had T cell responses to HIV.en_US
dc.identifier.citationVardas, Eftyhia, Kaleebu, Pontiano, Bekker, Linda-Gail, Hoosen, Anwar, Chomba, Elwyn, Johnson Philip R., Anklesaria, Pervin, Birungi, Josephine, Barin, Burc, Boaz, Mark, Cox, Josephine, Lehrman, Jennifer, Stevens, Gwynn, Gilmour, Jill, Tarragona, Tony, Hayes, Peter, Lowenbein, Sarah, Kizito, Eva, Fast, Patricia, Heald, Alison E., Schmidt, Claudia, 2010. A Phase 2 Study to Evaluate the Safety and Immunogenicity of a Recombinant HIV Type 1 Vaccine Based on Adeno-Associated Virus.en_US
dc.identifier.urihttps://hdl.handle.net/20.500.11951/274
dc.language.isoenen_US
dc.publisherMary Ann Liebert, Inc.en_US
dc.subjectImmunogenicityen_US
dc.subjectRecombinant HIV Type 1 Vaccineen_US
dc.subjectAdeno-Associated Virusen_US
dc.titleA Phase 2 Study to Evaluate the Safety and Immunogenicity of a Recombinant HIV Type 1 Vaccine Basedon Adeno-Associated Virus.en_US
dc.typeArticleen_US
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The final, definitive version of this paper has been published in the AIDs Research and Human Retroviruses, Vol.26, Number 8, August/2010. DOI: 10.1089/aid.2009.0242; Published by Mary Ann Liebert, Inc. All rights reserved.
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