Год публикации:
Все года
2018
2019
2020
Название |
Дата публикации |
Коллектив авторов |
Журнал |
DOI |
Индекс цитирования |
Ссылка на источник |
First-in-human trials of gamtbvac, a recombinant subunit tuberculosis vaccine candidate: Safety and immunogenicity assessment
|
01.12.2019 |
Vasina D.
Kleymenov D.
Manuylov V.
Mazunina E.
Koptev E.
Tukhovskaya E.
Murashev A.
Gintsburg A.
Gushchin V.
Tkachuk A.
|
Vaccines |
10.3390/vaccines7040166 |
0 |
Ссылка
© 2019, MDPI AG. All rights reserved. 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 double-immunization 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; DEAE-Dextran 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.
Читать
тезис
|