Safety and immunogenicity of therapeutic DNA vaccination in individuals treated with antiretroviral therapy during acute/early HIV-1 infection

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Safety and immunogenicity of therapeutic DNA vaccination in individuals treated with antiretroviral therapy during acute/early HIV-1 infection

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dc.contributor.author Graham, Barney S.
dc.contributor.author Stocker, Vicki
dc.contributor.author Maenza, Janine
dc.contributor.author Markowitz, Martin
dc.contributor.author Little, Susan
dc.contributor.author Collier, Ann C.
dc.contributor.author Nabel, Gary
dc.contributor.author Saindon, Suzanne
dc.contributor.author Flynn, Theresa
dc.contributor.author Ostrowski, Mario A.
dc.contributor.author Rosenberg, Eric Scott
dc.contributor.author Chan, Ellen S.L.
dc.contributor.author Bosch, Ronald J.
dc.contributor.author Sax, Paul Edward
dc.contributor.author Kuritzkes, Daniel Robert
dc.contributor.author Barouch, Dan Hung
dc.date.accessioned 2011-04-22T20:24:02Z
dc.date.issued 2010
dc.identifier.citation Rosenberg, Eric S., Barney S. Graham, Ellen S. Chan, Ronald J. Bosch, Vicki Stocker, Janine Maenza, Martin Markowitz, et al. 2010. Safety and immunogenicity of therapeutic DNA vaccination in individuals treated with antiretroviral therapy during acute/early HIV-1 infection. PLoS ONE 5(5): e10555. en_US
dc.identifier.issn 1932-6203 en_US
dc.identifier.uri http://nrs.harvard.edu/urn-3:HUL.InstRepos:4874536
dc.description.abstract Background: An effective therapeutic vaccine that could augment immune control of HIV-1 replication may abrogate or delay the need for antiretroviral therapy. AIDS Clinical Trials Group (ACTG) A5187 was a phase I/II, randomized, placebo-controlled, double-blinded trial to evaluate the safety and immunogenicity of an HIV-1 DNA vaccine (VRC-HVDNA 009-00-VP) in subjects treated with antiretroviral therapy during acute/early HIV-1 infection. (clinicaltrials.gov NCT00125099) Methods: Twenty healthy HIV-1 infected subjects who were treated with antiretroviral therapy during acute/early HIV-1 infection and had HIV-1 RNA<50 copies/mL were randomized to receive either vaccine or placebo. The objectives of this study were to evaluate the safety and immunogenicity of the vaccine. Following vaccination, subjects interrupted antiretroviral treatment, and set-point HIV-1 viral loads and CD4 T cell counts were determined 17–23 weeks after treatment discontinuation. Results: Twenty subjects received all scheduled vaccinations and discontinued antiretroviral therapy at week 30. No subject met a primary safety endpoint. No evidence of differences in immunogenicity were detected in subjects receiving vaccine versus placebo. There were also no significant differences in set-point HIV-1 viral loads or CD4 T cell counts following treatment discontinuation. Median set-point HIV-1 viral loads after treatment discontinuation in vaccine and placebo recipients were 3.5 and 3.7 log[sub]10 HIV-1 RNA copies/mL, respectively. Conclusions: The HIV-1 DNA vaccine (VRC-HIVDNA 009-00-VP) was safe but poorly immunogenic in subjects treated with antiretroviral therapy during acute/early HIV-1 infection. Viral set-points were similar between vaccine and placebo recipients following treatment interruption. However, median viral load set-points in both groups were lower than in historical controls, suggesting a possible role for antiretroviral therapy in persons with acute or early HIV-1 infection and supporting the safety of discontinuing treatment in this group. Trial Registration: Clinicaltrials.gov NCT00125099 en_US
dc.language.iso en_US en_US
dc.publisher Public Library of Science en_US
dc.relation.isversionof doi:10.1371/journal.pone.0010555 en_US
dc.relation.hasversion http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2866663/pdf/ en_US
dash.license LAA
dc.subject virology en_US
dc.subject immunology en_US
dc.subject immunomodulation en_US
dc.subject infectious diseases en_US
dc.subject HIV infection and AIDS en_US
dc.title Safety and immunogenicity of therapeutic DNA vaccination in individuals treated with antiretroviral therapy during acute/early HIV-1 infection en_US
dc.type Journal Article en_US
dc.description.version Version of Record en_US
dc.relation.journal PLoS ONE en_US
dash.depositing.author Rosenberg, Eric Scott
dc.date.available 2011-04-22T20:24:02Z
dash.affiliation.other HMS^Medicine-Massachusetts General Hospital en_US
dash.affiliation.other SPH^Center for Biostatistics in AIDS Research en_US
dash.affiliation.other SPH^Center for Biostatistics in AIDS Research en_US
dash.affiliation.other HMS^Medicine-Brigham and Women's Hospital en_US

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