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PLoS Negl Trop Dis. 2011 Oct;5(10):e1289. doi: 10.1371/journal.pntd.0001289. Epub 2011 Oct 18.

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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  • 1National Institute of Cholera and Enteric Diseases, Kolkata, India.

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00289224.

PMID:
22028938
[PubMed - indexed for MEDLINE]
PMCID:
PMC3196468
Free PMC Article
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