Results of phase I clinical trials of a combined vaccine against HIV-1 based on synthetic polyepitope immunogens

L. I. Karpenko; S. I. Bazhan; M. P. Bogryantseva; N. N. Ryndyuk; Z. I. Ginko; V. I. Kuzubov; L. R. Lebedev; O. N. Kaplina; A. Yu. Reguzova; A. B. Ryzhikov; S. V. Usova; S. F. Oreshkova; E. A. Nechaeva; E. D. Danilenko; A. A. Ilyichev

doi:10.1134/S1068162016020060

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
Affiliations:
1. Vector State Research Center of Virology and Biotechnology, Koltsovo
2. 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

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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.

Keywords

HIV vaccine, synthetic polyepitope immunogens, DNA vaccine, HIV-1, virus-like particles, phase I clinical trials

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Results of phase I clinical trials of a combined vaccine against HIV-1 based on synthetic polyepitope immunogens

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Abstract

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About the authors

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