Efficacy of a low-cost, inactivated whole-cell oral cholera vaccine: results from 3 years of follow-up of a randomized, controlled trial.

Autor: 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, Thu Van Nguyen, Seung Hyun Han, Stephen Attridge, Allan Donner, Nirmal K Ganguly, Sujit K Bhattacharya, G Balakrish Nair, John D Clemens, Anna Lena Lopez
Jazyk: angličtina
Rok vydání: 2011
Předmět:
Zdroj: PLoS Neglected Tropical Diseases, Vol 5, Iss 10, p e1289 (2011)
Druh dokumentu: article
ISSN: 1935-2727
1935-2735
DOI: 10.1371/journal.pntd.0001289
Popis: 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.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
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