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dc.contributor.authorSur, D.
dc.contributor.authorKanungo, S.
dc.contributor.authorSah, B.
dc.contributor.authorManna, B.
dc.contributor.authorAli, Mohammed
dc.contributor.authorPaisley, A.
dc.contributor.authorNiyogi, S.
dc.contributor.authorPark, J.
dc.contributor.authorSarkar, B.
dc.contributor.authorPuri, M.
dc.contributor.authorKim, D.
dc.contributor.authorDeen, J.
dc.contributor.authorHolmgren, J.
dc.contributor.authorCarbis, R.
dc.contributor.authorRao, R.
dc.contributor.authorvan Thu, N.
dc.contributor.authorHan, S.
dc.contributor.authorAttridge, S.
dc.contributor.authorDonner, A.
dc.contributor.authorGanguly, N.
dc.contributor.authorBhattacharya, S.
dc.contributor.authorNair, G.
dc.contributor.authorClemens, J.
dc.contributor.authorLopez, A.
dc.identifier.citationSur, D. and Kanungo, S. and Sah, B. and Manna, B. and Ali, M. and Paisley, A. and Niyogi, S. et al. 2011. Efficacy of a Low-Cost, inactivated Whole-Cell oral cholera vaccine: Results from 3 years of Follow-Up of a randomized, controlled trial. PLoS Neglected Tropical Diseases. 5 (10).

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. Conclus ions/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. Trial Registration: NCT00289224. © 2011 Sur et al.

dc.publisherPublic Library of Science
dc.titleEfficacy of a Low-Cost, inactivated Whole-Cell oral cholera vaccine: Results from 3 years of Follow-Up of a randomized, controlled trial
dc.typeJournal Article
dcterms.source.titlePLoS Neglected Tropical Diseases
curtin.departmentSchool of Nursing, Midwifery and Paramedicine
curtin.accessStatusOpen access via publisher

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