The Increase of the Magnitude of Spontaneous Viral Blips in Some Participants of Phase II Clinical Trial of Therapeutic Optimized HIV DNA Vaccine Candidate
| Autor: | Olga Zozulya, Valeriy Poddubnyy, Sergey V. Verevochkin, Natalia Vostokova, Ekaterina Akulova, Boris Murashev, Ruslan Al-Shekhadat, A. P. Kozlov, Alexey Masharsky |
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| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
DNA vaccine Immunology Phases of clinical research lcsh:Medicine Placebo Article DNA vaccination 03 medical and health sciences 0302 clinical medicine Plasmid Acquired immunodeficiency syndrome (AIDS) Drug Discovery medicine Pharmacology (medical) 030212 general & internal medicine Pharmacology business.industry lcsh:R HIV clinical trial medicine.disease Virology Clinical trial AIDS 030104 developmental biology Infectious Diseases therapeutic vaccine business Viral load Dose selection |
| Zdroj: | Vaccines, Vol 7, Iss 3, p 92 (2019) Vaccines Volume 7 Issue 3 |
| Popis: | We developed a candidate DNA vaccine called &ldquo DNA-4&rdquo 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 &ldquo This was a multicenter, double-blind, placebo-controlled clinical trial of safety, and dose selection of &ldquo in HIV-1 infected people receiving antiretroviral therapy (ART). Fifty-four patients were randomized into 3 groups (17 patients&mdash group DNA-4 0.25 mg, 17 patients&mdash group DNA-4 0.5 mg, 20 patients&mdash the placebo group). All patients were immunized 4 times on days 0, 7, 11, and 15 followed by a 24-week follow-up period. &ldquo 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&mdash 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. |
| Databáze: | OpenAIRE |
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