Efficacy of a single-dose regimen of inactivated whole-cell oral cholera vaccine: results from 2 years of follow-up of a randomised trial.
Firdausi Qadri, Mohammad Ali, Julia Lynch...
https://pubmed.ncbi.nlm.nih.gov/29550406/Actively Recruiting
Led by International Centre for Diarrhoeal Disease Research, Bangladesh · Updated on 2026-07-06
68400
Participants Needed
1
Research Sites
17 weeks
Total Duration
Researchers are evaluating the effectiveness of the Case Area Targeted Interventions CATI approach in reducing cholera incidence among household contacts and neighbors within cholera hotspots in Dhaka city. This study focuses on administering the Oral Cholera Vaccine OCV either as a single dose or two doses one month apart, targeting individuals aged 1 year and older who are not pregnant. The study also explores the genome analysis and immune response to V. cholerae antigens in different hotspots. Cholera cases are identified by rapid diagnostic tests among diarrheal patients at icddr,b Dhaka Hospital, and hotspots are defined as households within a 20-40 meter radius around the index cases. Participants are enrolled in clusters averaging 150 individuals per hotspot area on the same day as the index case identification. The intervention involves giving either one dose or two doses of OCV, with children under 5 years receiving two doses 14 days apart per WHO guidelines. Passive surveillance for cholera cases will be conducted through icddr,b hospital and other health facilities throughout the study. Data on individuals infection states, such as susceptible or infectious, will be tracked during a three-year follow-up period. During the trial, participants will be monitored through passive surveillance and data collection on cholera incidence. The primary outcome measured is the number of culture-confirmed V. cholerae cases from enrollment through the three-year follow-up. The study involves signed informed consent, and eligibility criteria include age, pregnancy status, and vaccination history. The trial aims to provide insights into the effectiveness of rapid targeted vaccination in reducing cholera transmission in endemic urban settings.
CONDITIONS
Cholera Control by Case-area Targeted Interventions (CATIs)
D
Dr. Fahima Chowdhury, MBBS, MPH, PhD
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International Centre for Diarrhoeal Disease Research, Bangladesh
Lead Sponsor
Wellcome Sanger Institute
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - One day for enrollment and vaccination
Participants receive either one dose or two doses of the oral cholera vaccine, with children under 5 years receiving two doses 14 days apart. Some participants do not receive the vaccine as a control group.
One visit for vaccination and enrollment
Duration - 3 years
Participants are monitored through passive surveillance at hospitals and health facilities to track cholera cases and immune responses over three years.
Regular passive surveillance throughout follow-up
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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https://pubmed.ncbi.nlm.nih.gov/27765293/International Centre for Diarrhoeal Disease Research, Bangladesh
Lead Sponsor
Wellcome Sanger Institute
Collaborating Sponsor