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Safety, Tolerability, and Immunogenicity of Repeated Doses of DermaVir, a Candidate Therapeutic HIV Vaccine, in HIV-Infected Patients Receiving Combination Antiretroviral Therapy: Results of the ACTG 5176 Trial
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Safety, Tolerability, and Immunogenicity of Repeated Doses of DermaVir, a Candidate Therapeutic HIV Vaccine, in HIV-Infected Patients Receiving Combination Antiretroviral Therapy: Results of the ACTG 5176 Trial

Benigno Rodriguez, David M. Asmuth, Roy M. Matining, John Spritzler, Jeffrey M. Jacobson, Robbie B. Mailliard, Xiao-Dong Li, Ana I. Martinez, Allan R. Tenorio, Franco Lori, …
JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES, v 64(4), pp 351-359
01 Dec 2013
DOI: https://doi.org/10.1097/QAI.0b013e3182a99590
PMID: 24169120
Featured in Collection :   UN Sustainable Development Goals @ Drexel
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https://doi.org/10.1097/qai.0b013e3182a99590View
Accepted (AM)Open Access (License Unspecified),  Open

Abstract

Immunology Infectious Diseases Life Sciences & Biomedicine Science & Technology
Background: HIV-specific cellular immune responses are associated with control of viremia and delayed disease progression. An effective therapeutic vaccine could mimic these effects and reduce the need for continued antiretroviral therapy. DermaVir, a topically administered plasmid DNA-nanomedicine expressing HIV (CladeB) virus-like particles consisting of 15 antigens, induces predominantly central memory T-cell responses. Methods: Treated HIV-infected adults (HIV RNA <50 and CD4 >350) were randomized to placebo or escalating DermaVir doses (0.1 or 0.4 mg of plasmid DNA at weeks 1, 7, and 13 in the low-and intermediate-dose groups and 0.8 mg at weeks 0, 1, 6, 7, 12, and 13 in the high-dose group), n = 5-6 evaluable subjects per group. Immunogenicity was assessed by a 12-day cultured interferon-g enzyme-linked immunosorbent spot assay at baseline and at weeks 9, 17, and 37 using 1 Tat/Rev and 3 overlapping Gag peptide pools (p17, p24, and p15). Results: Groups were comparable at baseline. The study intervention was well tolerated, without dose-limiting toxicities. Most responses were highest at week 17 (4 weeks after last vaccination) when Gag p24 responses were significantly greater among intermediate-dose group compared with control subjects [median (IQR): 67,600 (5633-74,368) versus 1194 (9-1667)] net spot-forming units per million cells, P = 0.032. In the intermediate-dose group, there was also a marginal Gag p15 response increase from baseline to week 17 [2859 (1867-56,933), P = 0.06], and this change was significantly greater than in the placebo group [0 (2713 to 297), P = 0.016]. Conclusions: DermaVir administration was associated with a trend toward greater HIV-specific, predominantly central memory T-cell responses. The intermediate DermaVir dose tended to show the greatest immunogenicity, consistent with previous studies in different HIV-infected patient populations.

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Web of Science research areas
Immunology
Infectious Diseases
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