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Type: Journal article
Title: Efficacy of a low-cost, inactivated whole-cell oral cholera vaccine: results from 3 years of follow-up of a randomized, controlled trial
Author: Sur, D.
Kanungo, S.
Sah, B.
Manna, B.
Ali, M.
Paisley, A.M.
Niyogi, S.K.
Park, J.K.
Sarkar, B.
Puri, M.K.
Kim, D.R.
Deen, J.L.
Holmgren, J.
Carbis, R.
Rao, R.
Thu Van, N.
Han, S.H.
Attridge, S.
Donner, A.
Ganguly, N.K.
et al.
Citation: PLoS Neglected Tropical Diseases, 2011; 5(10):e1289-1-e1289-6
Publisher: Public Library of Science
Issue Date: 2011
ISSN: 1935-2735
Statement of
Dipika Sur ... Stephen Attridge ... et al.
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<0.001). Vaccine protection during the third year of follow-up was 65% (one-sided 95%CI lower bound = 44%, p<0.001). Significant protection was evident in the second year of follow-up in children vaccinated at ages 1–4 years and in the third year in older age groups. CONCLUSIONS/SIGNIFICANCE: The killed whole-cell OCV conferred significant protection that was evident in the second year of follow-up in young children and was sustained for at least three years in older age groups. Continued follow-up will be important to establish the vaccine's duration of protection.
Rights: © 2011 Sur et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
RMID: 0030022101
DOI: 10.1371/journal.pntd.0001289
Appears in Collections:Molecular and Biomedical Science publications

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