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Efficacy of a Low-Cost, Inactivated Whole-Cell Oral Cholera Vaccine: Results from 3 Years of Follow-Up of a Randomized, Controlled Trial

Author

Listed:
  • 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 Thu Van
  • Seung Hyun Han
  • Stephen Attridge
  • Allan Donner
  • Nirmal K Ganguly
  • Sujit K Bhattacharya
  • G Balakrish Nair
  • John D Clemens
  • Anna Lena Lopez

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

Suggested Citation

  • 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 &, 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, Public Library of Science, vol. 5(10), pages 1-6, October.
    • Handle: RePEc:plo:pntd00:0001289
    DOI: 10.1371/journal.pntd.0001289
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