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Open AccessArticle

The Increase of the Magnitude of Spontaneous Viral Blips in Some Participants of Phase II Clinical Trial of Therapeutic Optimized HIV DNA Vaccine Candidate

1
Laboratory of Molecular Biology of HIV, Research Institute of Ultra Pure Biologicals, St. Petersburg 197110, Russia
2
The Biomedical Center, St. Petersburg 194044, Russia
3
Innovative Pharma, Mosco 143026, Russia
*
Author to whom correspondence should be addressed.
Vaccines 2019, 7(3), 92; https://doi.org/10.3390/vaccines7030092
Received: 29 March 2019 / Revised: 21 June 2019 / Accepted: 14 August 2019 / Published: 20 August 2019
(This article belongs to the Special Issue Advances in DNA Vaccines)
We developed a candidate DNA vaccine called “DNA-4”consisting of 4 plasmid DNAs encoding Nef, Gag, Pol(rt), and gp140 HIV-1 proteins. The vaccine was found to be safe and immunogenic in a phase I clinical trial. Here we present the results of a phase II clinical trial of “DNA-4”. This was a multicenter, double-blind, placebo-controlled clinical trial of safety, and dose selection of “DNA-4” in HIV-1 infected people receiving antiretroviral therapy (ART). Fifty-four patients were randomized into 3 groups (17 patients—group DNA-4 0.25 mg, 17 patients—group DNA-4 0.5 mg, 20 patients—the placebo group). All patients were immunized 4 times on days 0, 7, 11, and 15 followed by a 24-week follow-up period. “DNA-4” was found to be safe and well-tolerated at doses of 0.25 mg and 0.5 mg. We found that the amplitudes of the spontaneous viral load increases in three patients immunized with the candidate DNA vaccine were much higher than that in placebo group—2800, 180,000 and 709 copies/mL, suggesting a possible influence of therapeutic DNA vaccination on viral reservoirs in some patients on ART. We hypothesize that this influence was associated with the reactivation of proviral genomes. View Full-Text
Keywords: HIV; AIDS; DNA vaccine; clinical trial; therapeutic vaccine HIV; AIDS; DNA vaccine; clinical trial; therapeutic vaccine
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Akulova, E.; Murashev, B.; Verevochkin, S.; Masharsky, A.; Al-Shekhadat, R.; Poddubnyy, V.; Zozulya, O.; Vostokova, N.; Kozlov, A.P. The Increase of the Magnitude of Spontaneous Viral Blips in Some Participants of Phase II Clinical Trial of Therapeutic Optimized HIV DNA Vaccine Candidate. Vaccines 2019, 7, 92.

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