Results of phase I clinical trials of a combined vaccine against HIV-1 based on synthetic polyepitope immunogens
- Authors: Karpenko L.I.1, Bazhan S.I.1, Bogryantseva M.P.1, Ryndyuk N.N.2, Ginko Z.I.2, Kuzubov V.I.2, Lebedev L.R.1, Kaplina O.N.1, Reguzova A.Y.1, Ryzhikov A.B.1, Usova S.V.1, Oreshkova S.F.1, Nechaeva E.A.1, Danilenko E.D.1, Ilyichev A.A.1
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Affiliations:
- Vector State Research Center of Virology and Biotechnology, Koltsovo
- 163 Medical Unit of the Federal Medical and Biological Agency of Russia, Koltsovo
- Issue: Vol 42, No 2 (2016)
- Pages: 170-182
- Section: Article
- URL: https://journals.rcsi.science/1068-1620/article/view/227869
- DOI: https://doi.org/10.1134/S1068162016020060
- ID: 227869
Cite item
Abstract
The CombiHIVvac candidate vaccine against HIV-1/AIDS containing two synthetic polyepitope immunogens such as TBI and TCI to stimulate the humoral and cellular response is described. The recombinant TBI protein is constructed as a polypeptide with predetermined tertiary structure and contains epitopes of Env and Gag proteins of HIV-1. TCI contains CD8+ CTL and CD4+ Th epitopes of the major viral proteins such as Env, Gag, Pol and Nef which are highly conserved among subtypes A, B and C of HIV-1. A gene encoding the polyepitope TCI immunogen is inserted into a pcDNA-3.1 plasmid vector. The CombiHIVvac vaccine was designed as virus-like particles containing the pcDNA-TCI plasmid in their cores (DNA vaccine) and the TBI protein conjugated with polyglucin on their surfaces. Immunogenicity and safety of CombiHIVvac has been shown in preclinical studies in several animal species. Phase I clinical trials of the vaccine have been completed and the results obtained in human volunteers confirmed that the CombiHIVvac candidate vaccine was safe and did not cause side effects, at the same time, inducing the HIV-specific humoral and cellular immune response. The phase II clinical trials have been approved by the Ministry of Health and Social Development of the Russian Federation.
About the authors
L. I. Karpenko
Vector State Research Center of Virology and Biotechnology, Koltsovo
Author for correspondence.
Email: karpenko@vector.nsc.ru
Russian Federation, Novosibirsk oblast, 630559
S. I. Bazhan
Vector State Research Center of Virology and Biotechnology, Koltsovo
Email: karpenko@vector.nsc.ru
Russian Federation, Novosibirsk oblast, 630559
M. P. Bogryantseva
Vector State Research Center of Virology and Biotechnology, Koltsovo
Email: karpenko@vector.nsc.ru
Russian Federation, Novosibirsk oblast, 630559
N. N. Ryndyuk
163 Medical Unit of the Federal Medical and Biological Agency of Russia, Koltsovo
Email: karpenko@vector.nsc.ru
Russian Federation, Novosibirsk oblast, 630559
Z. I. Ginko
163 Medical Unit of the Federal Medical and Biological Agency of Russia, Koltsovo
Email: karpenko@vector.nsc.ru
Russian Federation, Novosibirsk oblast, 630559
V. I. Kuzubov
163 Medical Unit of the Federal Medical and Biological Agency of Russia, Koltsovo
Email: karpenko@vector.nsc.ru
Russian Federation, Novosibirsk oblast, 630559
L. R. Lebedev
Vector State Research Center of Virology and Biotechnology, Koltsovo
Email: karpenko@vector.nsc.ru
Russian Federation, Novosibirsk oblast, 630559
O. N. Kaplina
Vector State Research Center of Virology and Biotechnology, Koltsovo
Email: karpenko@vector.nsc.ru
Russian Federation, Novosibirsk oblast, 630559
A. Yu. Reguzova
Vector State Research Center of Virology and Biotechnology, Koltsovo
Email: karpenko@vector.nsc.ru
Russian Federation, Novosibirsk oblast, 630559
A. B. Ryzhikov
Vector State Research Center of Virology and Biotechnology, Koltsovo
Email: karpenko@vector.nsc.ru
Russian Federation, Novosibirsk oblast, 630559
S. V. Usova
Vector State Research Center of Virology and Biotechnology, Koltsovo
Email: karpenko@vector.nsc.ru
Russian Federation, Novosibirsk oblast, 630559
S. F. Oreshkova
Vector State Research Center of Virology and Biotechnology, Koltsovo
Email: karpenko@vector.nsc.ru
Russian Federation, Novosibirsk oblast, 630559
E. A. Nechaeva
Vector State Research Center of Virology and Biotechnology, Koltsovo
Email: karpenko@vector.nsc.ru
Russian Federation, Novosibirsk oblast, 630559
E. D. Danilenko
Vector State Research Center of Virology and Biotechnology, Koltsovo
Email: karpenko@vector.nsc.ru
Russian Federation, Novosibirsk oblast, 630559
A. A. Ilyichev
Vector State Research Center of Virology and Biotechnology, Koltsovo
Email: karpenko@vector.nsc.ru
Russian Federation, Novosibirsk oblast, 630559