Safety and Immunogenicity of DNA and MVA HIV-1 Subtype C Vaccine Prime-Boost Regimens: A Phase I Randomised Trial in HIV-Uninfected Indian Volunteers

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From: PLoS ONE(Vol. 8, Issue 2)
Publisher: Public Library of Science
Document Type: Article
Length: 8,841 words
Lexile Measure: 1630L

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Abstract :

Study Design A randomized, double-blind, placebo controlled phase I trial. Methods The trial was conducted in 32 HIV-uninfected healthy volunteers to assess the safety and immunogenicity of prime-boost vaccination regimens with either 2 doses of ADVAX, a DNA vaccine containing Chinese HIV-1 subtype C env gp160, gag, pol and nef/tat genes, as a prime and 2 doses of TBC-M4, a recombinant MVA encoding Indian HIV-1 subtype C env gp160, gag, RT, rev, tat, and nef genes, as a boost in Group A or 3 doses of TBC-M4 alone in Group B participants. Out of 16 participants in each group, 12 received vaccine candidates and 4 received placebos. Results Both vaccine regimens were found to be generally safe and well tolerated. The breadth of anti-HIV binding antibodies and the titres of anti-HIV neutralizing antibodies were significantly higher (p Conclusions Although DNA priming resulted in enhancement of immune responses after 1.sup.st MVA boosting, the overall DNA prime MVA boost was not found to be immunologically superior to homologous MVA boosting. Trial Registration Clinical Trial Registry CTRI/2009/091/000051

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Gale Document Number: GALE|A478297848