drugset / Trial / NCT01339845
Introduction of Cholera Vaccine in Bangladesh
Completed
240000 enrolled
International Centre for Diarrhoeal Disease Research, Bangladesh
Bill and Melinda Gates Foundation · collabDhaka City Corporation, Ministry of Local Government and Rural Development, Bangladesh · collabDirectorate General of Health Services, Bangladesh · collabInternational Vaccine Institute · collabJohns Hopkins Bloomberg School of Public Health · collabSchool of Public Health and Health Professions, University at Buffalo, USA · collabUniversity of Maryland · collab
RandomizedParallel-groupOpen-labelHealth-services research
Summary
The purpose of this study is to conduct and evaluate the feasibility and effectiveness of a mass cholera vaccination program to reduce diarrhea due to Vibrio cholerae in a high incidence urban area. This study will also evaluate the feasibility of adding a household hand washing and safe drinking water promotion intervention to a cholera vaccine program and the overall impact of this combination on decreasing the incidence of diarrhea due to Vibrio cholerae.
Timeline
- Start
- 2009-09
- Primary completion
- 2016-12
- Completion
- 2016-12
Publications
- Background 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.
- Background Mahalanabis D, Lopez AL, Sur D, Deen J, Manna B, Kanungo S, von Seidlein L, Carbis R, Han SH, Shin SH, Attridge S, Rao R, Holmgren J, Clemens J, Bhattacharya SK. A randomized, placebo-controlled trial of the bivalent killed, whole-cell, oral cholera vaccine in adults and children in a cholera endemic area in Kolkata, India. PLoS One. 2008 Jun 4;3(6):e2323. doi: 10.1371/journal.pone.0002323.
- Jefferson T, Dooley L, Ferroni E, Al-Ansary LA, van Driel ML, Bawazeer GA, Jones MA, Hoffmann TC, Clark J, Beller EM, Glasziou PP, Conly JM. Physical interventions to interrupt or reduce the spread of respiratory viruses. Cochrane Database Syst Rev. 2023 Jan 30;1(1):CD006207. doi: 10.1002/14651858.CD006207.pub6.
- Kang S, Chowdhury F, Park J, Ahmed T, Tadesse BT, Islam MT, Kim DR, Im J, Aziz AB, Hoque M, Pak G, Khanam F, Ahmmed F, Liu X, Zaman K, Khan AI, Kim JH, Marks F, Qadri F, Clemens JD. Are better existing WASH practices in urban slums associated with a lower long-term risk of severe cholera? A prospective cohort study with 4 years of follow-up in Mirpur, Bangladesh. BMJ Open. 2022 Sep 21;12(9):e060858. doi: 10.1136/bmjopen-2022-060858.
- Ali M, Qadri F, Kim DR, Islam MT, Im J, Ahmmed F, Khan AI, Zaman K, Marks F, Kim JH, Clemens JD. Effectiveness of a killed whole-cell oral cholera vaccine in Bangladesh: further follow-up of a cluster-randomised trial. Lancet Infect Dis. 2021 Oct;21(10):1407-1414. doi: 10.1016/S1473-3099(20)30781-7. Epub 2021 Jun 16.
- Jefferson T, Del Mar CB, Dooley L, Ferroni E, Al-Ansary LA, Bawazeer GA, van Driel ML, Jones MA, Thorning S, Beller EM, Clark J, Hoffmann TC, Glasziou PP, Conly JM. Physical interventions to interrupt or reduce the spread of respiratory viruses. Cochrane Database Syst Rev. 2020 Nov 20;11(11):CD006207. doi: 10.1002/14651858.CD006207.pub5.
- Saha A, Hayen A, Ali M, Rosewell A, MacIntyre CR, Clemens JD, Qadri F. Socioeconomic drivers of vaccine uptake: An analysis of the data of a geographically defined cluster randomized cholera vaccine trial in Bangladesh. Vaccine. 2018 Jul 25;36(31):4742-4749. doi: 10.1016/j.vaccine.2018.04.084. Epub 2018 May 8.
- Khan AI, Ali M, Chowdhury F, Saha A, Khan IA, Khan A, Akter A, Asaduzzaman M, Islam MT, Kabir A, You YA, Saha NC, Cravioto A, Clemens JD, Qadri F. Safety of the oral cholera vaccine in pregnancy: Retrospective findings from a subgroup following mass vaccination campaign in Dhaka, Bangladesh. Vaccine. 2017 Mar 13;35(11):1538-1543. doi: 10.1016/j.vaccine.2017.01.080. Epub 2017 Feb 11.
- Qadri F, Ali M, Chowdhury F, Khan AI, Saha A, Khan IA, Begum YA, Bhuiyan TR, Chowdhury MI, Uddin MJ, Khan JAM, Chowdhury AI, Rahman A, Siddique SA, Asaduzzaman M, Akter A, Khan A, Ae You Y, Siddik AU, Saha NC, Kabir A, Riaz BK, Biswas SK, Begum F, Unicomb L, Luby SP, Cravioto A, Clemens JD. Feasibility and effectiveness of oral cholera vaccine in an urban endemic setting in Bangladesh: a cluster randomised open-label trial. Lancet. 2015 Oct 3;386(10001):1362-1371. doi: 10.1016/S0140-6736(15)61140-0. Epub 2015 Jul 9.
- Khan IA, Saha A, Chowdhury F, Khan AI, Uddin MJ, Begum YA, Riaz BK, Islam S, Ali M, Luby SP, Clemens JD, Cravioto A, Qadri F. Coverage and cost of a large oral cholera vaccination program in a high-risk cholera endemic urban population in Dhaka, Bangladesh. Vaccine. 2013 Dec 9;31(51):6058-64. doi: 10.1016/j.vaccine.2013.10.021. Epub 2013 Oct 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Shanchol | Vaccine | 1.5 ml | Oral |