Clinical trial reveals cholera vaccine is safe, offers protection for up to 2 years

Oct 9 2009

A clinical trial of an Indian-made "modified killed-whole-cell" oral cholera vaccine "that meets WHO standards" has found that the vaccine is safe and effective in children living in parts of India where the disease is endemic, Reuters reports. The researchers, who reported their findings in the journal Lancet, hope to soon introduce the vaccine into other cholera endemic settings.

The researchers studied a group of 107,774 people, over the age of 1 year, in Kolkata, India - half of whom received a two-dose regimen of the vaccine while the others received placebo - and tracked their outcomes over two years. The trial revealed the vaccine offered protection to children under the age of 5 years as well as older individuals. No adverse effects from the vaccine were reported (Lyn, 10/9).

The "trial shows that the modified killed-whole-cell oral vaccine is safe and efficacious, providing nearly 70 percent protection against clinically significant cholera for at least 2 years after vaccination," the researchers write in the Lancet. The authors also describe several reasons the cholera vaccine tested in the study would be suitable for mass immunization campaigns in developing countries (Clemens et al., 10/9).

"The story of the development of this vaccine underlines the success of an international collaborative effort of public—private partnership and academic research organisations when provided with adequate funding, infrastructure, and support," writes the author of an accompanying Lancet comment. "This success story ought to be an example for other vaccine initiatives, especially against malaria and HIV, to similarly engage industry and academia towards solving an urgent public health need" (Sridhar, 10/9).