NCT01339845

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2011

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 21, 2011

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 7, 2017

Status Verified

February 1, 2017

Enrollment Period

7.3 years

First QC Date

April 1, 2011

Last Update Submit

March 5, 2017

Conditions

Cholera

Keywords

Cholera vaccineBehaviour change interventionCost effectiveness and cost-benefitPrevention of choleraControl of CholeraVaccination

Outcome Measures

Primary Outcomes (2)

  • Number of individuals vaccinated with two dose of oral cholera vaccine.

    Tergated individuals will be vaccinated and vaccination records will give the coverage.

    Six months from initiation of vaccination

  • Decrease number of cholera cases in intervention arm compared to non-intervention arm.

    The primary analyses will be comparison of the incidence of primary outcome in the intervention clusters compared to the non-intervention cluster

    Two years after completion of vaccination

Secondary Outcomes (3)

  • Incidence of cholera among vaccinated individuals in vaccination area.

    Two years after completion of vaccination.

  • Incidence of cholera among non-vaccinated individuals in vaccination area.

    Two years after completion of vaccination

  • Incidence of cholera in the combined cholera vaccine and behavior change intervention area

    Two years after completion of vaccination

Study Arms (3)

Vaccine arm

ACTIVE COMPARATOR

Thirty clusters (approximately 80,000 people) will receive cholera vaccine alone

Biological: ShanChol

Vaccine plus hygiene and safe water arm

ACTIVE COMPARATOR

Thirty clusters (approximately 80,000 people)will receive both cholera vaccine and behaviour change

Behavioral: Vaccine and behaviour

Non-intervention arm

NO INTERVENTION

30 neighbourhoods(approximately 80,000 people) will continue their standard habits and practices

Interventions

ShanCholBIOLOGICAL

Each dose of the vaccine contains whole cell Killed inactivated V.cholerae O1 and O139 strains.Vaccine is packaged as liquid formulations in 1.5-ml doses. The vaccine is given two doses separated by a two week interval and administered orally.

Vaccine arm
Vaccine and behaviourBEHAVIORAL

Together with vaccination the community health worker will offer a hand washing station and water treatment facilities that include both hardware and a software component. The idea of the handwashing station is to bring together with soap and water that people need for handwashing, especially for handwashing after defecation. The hardware for water treatment is a chlorine dispenser that is a reservoir which holds sodium hypochlorite and dispenses a measured dose of the dilute sodium hypochlorite into a 15 liter water tank. Community residents can collect water directly from the 15 L water tanks into their own personal water storage vessels. The community health worker will negotiate with compound residents for the development of a water treatment system.

Vaccine plus hygiene and safe water arm

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Apparently healthy residents of selected vaccination sites
  • Aged 1 year and above
  • Non-pregnant women
  • Written informed consent

You may not qualify if:

  • Age less than 1 year
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, Dhaka Division, 1212, Bangladesh

Location

Related Publications (10)

  • 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.

    PMID: 19819004BACKGROUND

  • 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.

    PMID: 18523643BACKGROUND

  • 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.

    PMID: 36715243DERIVED

  • 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.

    PMID: 36130764DERIVED

  • 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.

    PMID: 34146473DERIVED

  • 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.

    PMID: 33215698DERIVED

  • 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.

    PMID: 29752024DERIVED

  • 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.

    PMID: 28196715DERIVED

  • 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.

    PMID: 26164097DERIVED

  • 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.

    PMID: 24161413DERIVED

MeSH Terms

Conditions

Cholera

Interventions

shancholVaccines

Condition Hierarchy (Ancestors)

Vibrio InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Biological ProductsComplex Mixtures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2011

First Posted

April 21, 2011

Study Start

September 1, 2009

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

March 7, 2017

Record last verified: 2017-02

Locations

BA(1)