Efficacy of a Low-Cost, inactivated Whole-Cell oral cholera vaccine: Results from 3 years of Follow-Up of a randomized, controlled trial

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, Nguyen van Thu, Seung Hyun Han, Stephen Attridge, Allan Donner, Nirmal K. GangulySujit K. Bhattacharya, G. Balakrish Nair, John D. Clemens, Anna Lena Lopez

Research output: Contribution to journalArticle

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

Original languageEnglish (US)
Article numbere1289
JournalPLoS Neglected Tropical Diseases
Volume5
Issue number10
DOIs
StatePublished - Oct 2011

    Fingerprint

ASJC Scopus subject areas

  • Infectious Diseases
  • Public Health, Environmental and Occupational Health
  • Pharmacology, Toxicology and Pharmaceutics(all)

Cite this

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., van Thu, N., Han, S. H., Attridge, S., Donner, A., ... Lopez, A. L. (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), [e1289]. https://doi.org/10.1371/journal.pntd.0001289