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


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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.

作者简介

L. Karpenko

Vector State Research Center of Virology and Biotechnology, Koltsovo

编辑信件的主要联系方式.
Email: karpenko@vector.nsc.ru
俄罗斯联邦, Novosibirsk oblast, 630559

S. Bazhan

Vector State Research Center of Virology and Biotechnology, Koltsovo

Email: karpenko@vector.nsc.ru
俄罗斯联邦, Novosibirsk oblast, 630559

M. Bogryantseva

Vector State Research Center of Virology and Biotechnology, Koltsovo

Email: karpenko@vector.nsc.ru
俄罗斯联邦, Novosibirsk oblast, 630559

N. Ryndyuk

163 Medical Unit of the Federal Medical and Biological Agency of Russia, Koltsovo

Email: karpenko@vector.nsc.ru
俄罗斯联邦, Novosibirsk oblast, 630559

Z. Ginko

163 Medical Unit of the Federal Medical and Biological Agency of Russia, Koltsovo

Email: karpenko@vector.nsc.ru
俄罗斯联邦, Novosibirsk oblast, 630559

V. Kuzubov

163 Medical Unit of the Federal Medical and Biological Agency of Russia, Koltsovo

Email: karpenko@vector.nsc.ru
俄罗斯联邦, Novosibirsk oblast, 630559

L. Lebedev

Vector State Research Center of Virology and Biotechnology, Koltsovo

Email: karpenko@vector.nsc.ru
俄罗斯联邦, Novosibirsk oblast, 630559

O. Kaplina

Vector State Research Center of Virology and Biotechnology, Koltsovo

Email: karpenko@vector.nsc.ru
俄罗斯联邦, Novosibirsk oblast, 630559

A. Reguzova

Vector State Research Center of Virology and Biotechnology, Koltsovo

Email: karpenko@vector.nsc.ru
俄罗斯联邦, Novosibirsk oblast, 630559

A. Ryzhikov

Vector State Research Center of Virology and Biotechnology, Koltsovo

Email: karpenko@vector.nsc.ru
俄罗斯联邦, Novosibirsk oblast, 630559

S. Usova

Vector State Research Center of Virology and Biotechnology, Koltsovo

Email: karpenko@vector.nsc.ru
俄罗斯联邦, Novosibirsk oblast, 630559

S. Oreshkova

Vector State Research Center of Virology and Biotechnology, Koltsovo

Email: karpenko@vector.nsc.ru
俄罗斯联邦, Novosibirsk oblast, 630559

E. Nechaeva

Vector State Research Center of Virology and Biotechnology, Koltsovo

Email: karpenko@vector.nsc.ru
俄罗斯联邦, Novosibirsk oblast, 630559

E. Danilenko

Vector State Research Center of Virology and Biotechnology, Koltsovo

Email: karpenko@vector.nsc.ru
俄罗斯联邦, Novosibirsk oblast, 630559

A. Ilyichev

Vector State Research Center of Virology and Biotechnology, Koltsovo

Email: karpenko@vector.nsc.ru
俄罗斯联邦, Novosibirsk oblast, 630559

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