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

被引：10

作者：

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. Yu. ^{[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
]}

机构：

[1] Vector State Res Ctr Virol & Biotechnol, Koltsov 630559, Novosibirsk Obl, Russia

[2] Fed Med & Biol Agcy Russia, Med Unit 163, Koltsov 630559, Novosibirsk Obl, Russia

来源：

RUSSIAN JOURNAL OF BIOORGANIC CHEMISTRY | 2016年 / 42卷 / 02期

基金：

俄罗斯科学基金会;

关键词：

HIV vaccine; synthetic polyepitope immunogens; DNA vaccine; HIV-1; virus-like particles; phase I clinical trials; DNA-VACCINE; T-CELL; PROTEIN; EPITOPES; DESIGN; CONSTRUCTION; INFECTION; DEVELOP;

D O I：

10.1134/S1068162016020060

中图分类号：

Q5 [生物化学]; Q7 [分子生物学];

学科分类号：

071010 ; 081704 ;

摘要：

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.

引用

页码：170 / 182

页数：13

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