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


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Resumo

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.

Sobre autores

L. Karpenko

Vector State Research Center of Virology and Biotechnology, Koltsovo

Autor responsável pela correspondência
Email: karpenko@vector.nsc.ru
Rússia, Novosibirsk oblast, 630559

S. Bazhan

Vector State Research Center of Virology and Biotechnology, Koltsovo

Email: karpenko@vector.nsc.ru
Rússia, Novosibirsk oblast, 630559

M. Bogryantseva

Vector State Research Center of Virology and Biotechnology, Koltsovo

Email: karpenko@vector.nsc.ru
Rússia, Novosibirsk oblast, 630559

N. Ryndyuk

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

Email: karpenko@vector.nsc.ru
Rússia, Novosibirsk oblast, 630559

Z. Ginko

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

Email: karpenko@vector.nsc.ru
Rússia, Novosibirsk oblast, 630559

V. Kuzubov

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

Email: karpenko@vector.nsc.ru
Rússia, Novosibirsk oblast, 630559

L. Lebedev

Vector State Research Center of Virology and Biotechnology, Koltsovo

Email: karpenko@vector.nsc.ru
Rússia, Novosibirsk oblast, 630559

O. Kaplina

Vector State Research Center of Virology and Biotechnology, Koltsovo

Email: karpenko@vector.nsc.ru
Rússia, Novosibirsk oblast, 630559

A. Reguzova

Vector State Research Center of Virology and Biotechnology, Koltsovo

Email: karpenko@vector.nsc.ru
Rússia, Novosibirsk oblast, 630559

A. Ryzhikov

Vector State Research Center of Virology and Biotechnology, Koltsovo

Email: karpenko@vector.nsc.ru
Rússia, Novosibirsk oblast, 630559

S. Usova

Vector State Research Center of Virology and Biotechnology, Koltsovo

Email: karpenko@vector.nsc.ru
Rússia, Novosibirsk oblast, 630559

S. Oreshkova

Vector State Research Center of Virology and Biotechnology, Koltsovo

Email: karpenko@vector.nsc.ru
Rússia, Novosibirsk oblast, 630559

E. Nechaeva

Vector State Research Center of Virology and Biotechnology, Koltsovo

Email: karpenko@vector.nsc.ru
Rússia, Novosibirsk oblast, 630559

E. Danilenko

Vector State Research Center of Virology and Biotechnology, Koltsovo

Email: karpenko@vector.nsc.ru
Rússia, Novosibirsk oblast, 630559

A. Ilyichev

Vector State Research Center of Virology and Biotechnology, Koltsovo

Email: karpenko@vector.nsc.ru
Rússia, Novosibirsk oblast, 630559


Declaração de direitos autorais © Pleiades Publishing, Ltd., 2016

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