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Randomized placebo controlled human volunteer trial of a live oral cholera vaccine VA1.3 for safety and immune response.

Author(s): Mahalanabis D, Ramamurthy T, Nair GB, Ghosh A, Shaikh S, Sen B, Thungapathra M, Ghosh RK, Pazhani GP, Nandy RK, Jana S, Bhattacharya SK

Affiliation(s): Society for Applied Studies, CF-198, Salt Lake City, Sector-1, Kolkata, India. sascf198@yahoo.com

Publication date & source: 2009-07-30, Vaccine., 27(35):4850-6. Epub 2009 Jun 10.

Publication type: Randomized Controlled Trial; Research Support, Non-U.S. Gov't

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 (> or =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.

Page last updated: 2009-10-20

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