First-In-Human Trials of GamTBvac, a Recombinant Subunit Tuberculosis Vaccine Candidate: Safety and Immunogenicity Assessment

Vasina, D.V.; Kleymenov, D.A.; Manuylov, V.A.; Mazunina, E.P.; Koptev, E.Y.; Tukhovskaya, E.A.; Murashev, A.N.; Gintsburg, A.L.; Gushchin, V.A.; Tkachuk, A.P.

Статья опубликована в высокорейтинговом журнале

Информация о цитировании статьи получена из Web of Science, Scopus
Статья опубликована в журнале из списка Web of Science и/или Scopus
Дата последнего поиска статьи во внешних источниках: 24 января 2020 г.

Авторы: Vasina D.V., Kleymenov D.A., Manuylov V.A., Mazunina E.P., Koptev E.Y., Tukhovskaya E.A., Murashev A.N., Gintsburg A.L., Gushchin V.A., Tkachuk A.P.
Журнал: VACCINES
Том: 7
Номер: 166
Год издания: 2019
Первая страница: 1
Последняя страница: 16
DOI: 10.3390/vaccines7040166
Аннотация: Tuberculosis is known to be the biggest global health problem, causing the most deaths by a single infectious agent. Vaccine-development efforts are extremely important. This paper represents the results of the first-in-human trial of recombinant subunit tuberculosis vaccine GamTBvac in a Phase I study. GamTBvac is a new BCG booster candidate vaccine containing dextran-binding domain modified Ag85a and ESAT6-CFP10 MTB antigens and CpG ODN adjuvant, formulated with dextrans. Safety and immunogenicity of GamTBvac were estimated in an open-label clinical trial on 60 Mycobacterium tuberculosis uninfected (MTB-uninfected) volunteers previously-vaccinated with Bacillus Calmette—Guérin vaccine (BCG). The candidate vaccine had an acceptable safety profile and was well-tolerated. Three different vaccine doses with a doubleimmunization scheme were assessed for immunogenicity and induced a significant increase in IFN- γ in-house IGRA response and IgG ELISA analysis. Among them, the half dose vaccine group (containing DBD-ESAT6-CFP10, 12.5 μg; DBD-Ag85a, 12.5 μg; CpG (ODN 2216), 75 μg; DEAEDextran 500 kDa, 250 μg; and Dextran 500 kDa, 5 mg) provided high, early and stable in time immune response specific to both protein antigen fusions and is proposed for the further studies.
Добавил в систему: Гущин Владимир Алексеевич

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First-In-Human Trials of GamTBvac, a Recombinant Subunit Tuberculosis Vaccine Candidate: Safety and Immunogenicity Assessmentстатья Исследовательская статья

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