Efficacy of a Low-Cost, Inactivated Whole-Cell Oral Cholera Vaccine: Results from 3 Years of Follow-Up of a Randomized, Controlled Trial

Dipika Sur, Suman Kanungo, Binod Sah, Byomkesh Manna, Mohammad Ali, Allison M Paisley, Swapan K Niyogi, Jin Kyung Park, Banawarilal Sarkar, Mahesh K Puri, Deok Ryun Kim, Jacqueline L Deen, Jan Holmgren, Rodney Carbis, Raman Rao, Nguyen Thu Van, Seung Hyun Han, Stephen Attridge, Allan Donner, Nirmal K Ganguly, Sujit K Bhattacharya, G Balakrish Nair, John D Clemens and Anna Lena Lopez

PLOS Neglected Tropical Diseases, 2011, vol. 5, issue 10, 1-6

Abstract: Background: Killed oral cholera vaccines (OCVs) have been licensed for use in developing countries, but protection conferred by licensed OCVs beyond two years of follow-up has not been demonstrated in randomized, clinical trials. Methods/Principal Findings: We conducted a cluster-randomized, placebo-controlled trial of a two-dose regimen of a low-cost killed whole cell OCV in residents 1 year of age and older living in 3,933 clusters in Kolkata, India. The primary endpoint was culture-proven Vibrio cholerae O1 diarrhea episodes severe enough to require treatment in a health care facility. Of the 66,900 fully dosed individuals (31,932 vaccinees and 34,968 placebo recipients), 38 vaccinees and 128 placebo-recipients developed cholera during three years of follow-up (protective efficacy 66%; one-sided 95%CI lower bound = 53%, p

Date: 2011
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Persistent link: https://EconPapers.repec.org/RePEc:plo:pntd00:0001289

DOI: 10.1371/journal.pntd.0001289

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