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Studies have confirmed that a bivalent killed whole-cell oral cholera vaccine (Shanchol; Shantha Biotechnics, Hyderabad, India) can provide protection for up to 3 years (NEJM JW Infect Dis Oct 21 2009). To examine longer-term efficacy, researchers (1 of whom is a Shantha employee) conducted a double-blind, cluster-randomized, placebo-controlled trial in a slum in Kolkata, India, where cholera is endemic.
More than 65,000 nonpregnant residents aged ≥1 year received two doses of vaccine or placebo (heat-killed Escherichia coli K12) 14 days apart. The vaccine, prequalified by WHO in 2011, contains inactivated Vibrio cholerae O1 and V. cholerae O139. The primary endpoint was cases of culture-confirmed cholera severe enough to require treatment a…