Efficacy of a low-cost, inactivated whole-cell oral cholera vaccine: results from 3 years of follow-up of a randomized, controlled trial |
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Authors: | Sur Dipika Kanungo Suman Sah Binod Manna Byomkesh Ali Mohammad Paisley Allison M Niyogi Swapan K Park Jin Kyung Sarkar Banawarilal Puri Mahesh K Kim Deok Ryun Deen Jacqueline L Holmgren Jan Carbis Rodney Rao Raman Nguyen Thu Van Han Seung Hyun Attridge Stephen Donner Allan Ganguly Nirmal K Bhattacharya Sujit K Nair G Balakrish Clemens John D Lopez Anna Lena |
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Institution: | National Institute of Cholera and Enteric Diseases, Kolkata, India. |
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Abstract: | BackgroundKilled 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 FindingsWe 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/SignificanceThe 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.Trial RegistrationClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00289224","term_id":"NCT00289224"}}NCT00289224. |
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