FRIDAY, Oct. 9 (HealthDay News) -- An inexpensive, locally-produced oral cholera vaccine may benefit populations threatened by endemic cholera, according to a double-blind Indian study published online Oct. 9 in The Lancet.
Dipika Sur, M.D., of the National Institute of Cholera and Enteric Diseases in Kolkata, India, and colleagues evaluated the efficacy of a modified, locally-produced, killed-whole-cell vaccine compliant with World health Organization standards. The researchers randomized residents of Kolkata to receive two oral doses of either the modified killed-whole-cell cholera vaccine or a heat-killed Escherichia coli K12 placebo. The study end point was prevention of severe Vibrio cholerae O1 diarrhea.
The researchers identified 20 episodes of cholera out of the 31,932 participants in the modified-vaccine group (1721 clusters) and 68 episodes out of the 34,968 participants in the placebo group (1757 clusters), for a protective efficacy of 67 percent that extended to every age group and didn't differ much between groups. No vaccine-related serious adverse events were observed.
"This modified killed-whole-cell oral vaccine, compliant with WHO standards, is safe, provides protection against clinically significant cholera in an endemic setting, and can be used in children aged 1.0 to 4.9 years, who are at highest risk of developing cholera in endemic settings," the authors write.
Two of the study authors are employed by companies that produce vaccines.
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