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Cholera remains deadly despite effective treatment. In 2009, a killed bivalent whole-cell oral cholera vaccine was licensed in India. Clinical trials in Kolkata showed 67% protection at 3 years. To assess the feasibility and protective effectiveness of delivering the vaccine through routine public health programs, investigators undertook a cluster-randomized, open-label trial in a poor urban population in cholera-endemic Bangladesh.
Ninety geographic clusters were assigned to one of three groups: vaccination only, vaccination plus intervention (handwashing; home drinking-water chlorination), or no intervention. Participants in the vaccination groups received two vaccine doses ≥14 days apart. Passive diarrhea surveillance was conducted at 12 …