期刊
VACCINE
卷 27, 期 35, 页码 4850-4856出版社
ELSEVIER SCI LTD
DOI: 10.1016/j.vaccine.2009.05.065
关键词
Live oral cholera vaccine; Human volunteer trial; ctxB gene insertion
资金
- Department of Biotechnology
- Ministry of Science and Technology, Government of India
- Principal of ID & BG Hospital, Beliaghata, Kolkata
A live oral cholera vaccine developed from a non-toxigenic Vibrio cholerae O1 El Tor strain VA1.3 was tested in a double-blind randomized placebo controlled study for safety and immunogenicity in 304 men aged between 16 and 50 years from Kolkata, India. A dose of 5 x 10(9) CFU (n = 186) or a placebo (n = 116) containing the diluent buffer was administered. The vaccine did not elicit adverse events except in two vaccine recipients with mild diarrhoea and vomiting. None excreted the vaccine strain. Vibriocidal antibody response developed in 105/186 (57%) and 5/116 (4%) in vaccine and placebo recipients, respectively. In a subgroup, anti-CT antibody rose(>= 2-folds) in 23/30 (77%) and 6/19 (32%) in vaccine and placebo recipients, respectively. These studies demonstrate that VA1.3 at a dose of 5 x 10(9) is safe and immunogenic in adults from a cholera endemic region. (C) 2009 Elsevier Ltd. All rights reserved.
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