Randomized Controlled Trial of Killed Oral Cholera Vaccine in Kolkata

Summary

The primary purpose of this study is to estimate the efficacy of a two-dose regimen of the oral killed bivalent cholera vaccine when administered to individual residing in a cholera-endemic area in India.

Timeline

Start

2006-07

Primary completion

2011-12

Completion

2013-05

Outcome

Met primary endpoint

paper 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). PMID 22028938 ↗

Publications

• Results Sur D, Lopez AL, Kanungo S, Paisley A, Manna B, Ali M, Niyogi SK, Park JK, Sarkar B, Puri MK, Kim DR, Deen JL, Holmgren J, Carbis R, Rao R, Nguyen TV, Donner A, Ganguly NK, Nair GB, Bhattacharya SK, Clemens JD. Efficacy and safety of a modified killed-whole-cell oral cholera vaccine in India: an interim analysis of a cluster-randomised, double-blind, placebo-controlled trial. Lancet. 2009 Nov 14;374(9702):1694-702. doi: 10.1016/S0140-6736(09)61297-6. Epub 2009 Oct 8.
• Islam MT, Im J, Ahmmed F, Kim DR, Tadesse BT, Kang S, Khanam F, Chowdhury F, Ahmed T, Firoj MG, Aziz AB, Hoque M, Park J, Jeon HJ, Kanungo S, Dutta S, Zaman K, Khan AI, Marks F, Kim JH, Qadri F, Clemens JD. Better Existing Water, Sanitation, and Hygiene Can Reduce the Risk of Cholera in an Endemic Setting: Results From a Prospective Cohort Study From Kolkata, India. Open Forum Infect Dis. 2023 Nov 21;10(11):ofad535. doi: 10.1093/ofid/ofad535. eCollection 2023 Nov.
• Fong Y, Halloran ME, Park JK, Marks F, Clemens JD, Chao DL. Efficacy of a bivalent killed whole-cell cholera vaccine over five years: a re-analysis of a cluster-randomized trial. BMC Infect Dis. 2018 Feb 20;18(1):84. doi: 10.1186/s12879-018-2981-4.
• Ali M, Debes AK, Luquero FJ, Kim DR, Park JY, Digilio L, Manna B, Kanungo S, Dutta S, Sur D, Bhattacharya SK, Sack DA. Potential for Controlling Cholera Using a Ring Vaccination Strategy: Re-analysis of Data from a Cluster-Randomized Clinical Trial. PLoS Med. 2016 Sep 13;13(9):e1002120. doi: 10.1371/journal.pmed.1002120. eCollection 2016 Sep.
• Ali M, Sur D, You YA, Kanungo S, Sah B, Manna B, Puri M, Wierzba TF, Donner A, Nair GB, Bhattacharya SK, Dhingra MS, Deen JL, Lopez AL, Clemens J. Herd protection by a bivalent killed whole-cell oral cholera vaccine in the slums of Kolkata, India. Clin Infect Dis. 2013 Apr;56(8):1123-31. doi: 10.1093/cid/cit009. Epub 2013 Jan 29.
• Sur D, Kanungo S, Sah B, Manna B, Ali M, Paisley AM, Niyogi SK, Park JK, Sarkar B, Puri MK, Kim DR, Deen JL, Holmgren J, Carbis R, Rao R, Nguyen TV, Han SH, Attridge S, Donner A, Ganguly NK, Bhattacharya SK, Nair GB, Clemens JD, Lopez AL. Efficacy of a low-cost, inactivated whole-cell oral cholera vaccine: results from 3 years of follow-up of a randomized, controlled trial. PLoS Negl Trop Dis. 2011 Oct;5(10):e1289. doi: 10.1371/journal.pntd.0001289. Epub 2011 Oct 18.

Drugs

Indications