CholeraNCT07685574
Cholera Control by Case-area Targeted Interventions (CATIs)
A study testing Cholvax in people with Cholera and Methodology Study, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial summary
To evaluate the effectiveness of the CATI approach among household contacts in the reduction of cumulative incidence of cholera and explore the genome analysis and immune response of V. Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Cholera, Methodology Study
- What is being tested?
- Cholvax
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68,400 participants
- Where
- 1 siteBangladesh
- Study dates
- 5 Sep 2024to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Some to severe dehydrated diarrheal patient
- Provide signed informed consent form
- Aged ≥1 year and non-pregnant
- Meeting the definition of IHC and NHC
- Provide signed informed consent form
Who cannot join
- 1. Resident in a ward already covered by OCV since 2015
- Vaccination Eligibility
- History of taking OCV
- Currently suffering from diarrhea
- < 1 year of age
- Pregnant women (verbally confirmed)
- Index case
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site, 1 recruiting
- Recruiting
International Centre for Diarrhoeal Diseases Research, Bangladesh (icddr,b)
Dhaka, 1212
Dr. Firdausi Qadri, PhD, +8801711595367, fqadri@icddrb.org
About this study
Official title: Case-area Targeted Interventions (CATIs) Among Household Contacts and Neighbouring Households After Defining Cholera Hotspot Areas in Bangladesh: The Effectiveness of OCV and Potential Impact on Cholera Control
To evaluate the effectiveness of the CATI approach among household contacts in the reduction of cumulative incidence of cholera and explore the genome analysis and immune response of V. cholerae antigen from different hotspots in Dhaka city, cholera cases will be enrolled by rapid diagnostic test (RDT) from the diarrhoeal patients coming to icddr,b Dhaka hospital. Hotspots will be defined as the households (HHs) surrounding the RDT-positive cholera case (around 20-40m radius). The 'Case area targeted interventions' (CATI) will be given by administrating Oral Cholera Vaccine (OCV) with either one dose or two doses of OCV 1 month apart among household contacts (≥1-year age and non-pregnant women) and contacts of the contacts residing in the adjacent HHs. The passive surveillance for cholera will be followed using the icddr,b hospital, and other health facilities. Data on each individual's states of the clusters (e.g., susceptible, exposed, infectious, or recovered) will be tracked throughout the 3 years study follow-up.
Read the detailed description
Background (brief):
- Burden: Annually, 2.8 million cases and 95,000 deaths due to cholera are estimated to occur in cholera-endemic countries of Asia, Latin and Central America, and sub-Saharan Africa. The risk of cholera infection within the household and also around the households of cholera cases is higher than in the overall population. Outbreaks of cholera are unpredictable and can occur both in endemic settings and nonendemic areas depending on environmental conditions, climate change, or any humanitarian crisis where sanitary infrastructure is being disrupted. New phenotypes and genotypes of V. cholerae strains are constantly evolving with outbreaks, resulting in an increased risk of antimicrobial resistance (AMR).
- Knowledge gap: Standard cholera outbreak response and traditional vaccination campaign is time consuming, costly and usually delayed. A rapid response comprising an early detection of cholera case, hotspot identification and delivery of a rapid response to households around the case could reduce the transmission of disease. But it is not established that whether this early detection of cases and rapid intervention will reduce cholera transmission, also what number of oral cholera vaccine (OCV) will effectively reduce the transmission.
- Relevance: Availability of OCV is scarce but necessary for rapid response as it an effective short-term single intervention to shortened the epidemic period and cholera cases. This study aims to evaluate the effectiveness of the CATI approach (single/two doses at 1-month intervals) among household contacts and their neighbours in the reduction of the incidence of cholera
Hypothesis: Case area targeted intervention with OCV reduce the incidence of cholera after defining cholera hotspot.
Objectives: This study aims to evaluate the effectiveness of the CATI approach (OCV- one dose, two doses at one-month interval) among household contacts in the reduction of cumulative incidence of cholera and explore the genome analysis and immune response of V. cholerae antigen from different hotspots in Dhaka city.
Methods: The investigators will enroll cholera cases (index) by rapid diagnostic test (RDT) from the diarrhoeal patients coming to icddr,b Dhaka Hospital in and around Dhaka city based on our inclusion and exclusion criteria. Hotspots will be defined as the households (HHs) surrounding the RDT-positive cholera case (around 20-40m radius). The CATIs will be given by administrating OCV with either one dose or two doses of OCV 1 month apart among household contacts (≥1-year age and non-pregnant women) and contacts of the contacts residing in the adjacent HHs. The investigators will enrol on average 150 participants in each cluster of the index cases on the same day of the enrolment within the nearest geographic boundary (around 20-40m radius). Passive surveillance for cholera will be followed using the icddr,b hospital, and other selected health facilities. Data on each individual's states of the clusters (e.g., susceptible, exposed, infectious, or recovered) will be tracked throughout the 3 years study follow-up.
- Conditions
- Cholera, Methodology Study
- Being tested
- Cholvax
- Keywords
- Cholera, CATI, Cholera Vaccine, Bangladesh
- Medical subject headings
- Cholera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholvaxBiological
Produced in Bangladesh and Licenced by the Directorate of Drug Administration (DGDA) for use in Bangladesh
| Study group | Role | What they receive |
|---|---|---|
| A) the intervention arm receiving a single dose | Experimental | dose (<5 years old children will receive two doses of OCV at 14 days interval according to the WHO guideline) Receives: Biological: Cholvax |
| B) the intervention arm receiving two doses at 1-month interval | Experimental | Not described Receives: Biological: Cholvax |
| C) no intervention or control arm | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of culture-confirmed V. cholerae
Number of culture-confirmed V. cholerae within 3 years. Stool samples from participants with diarrhea will be cultured for V. cholerae.
Measured: From enrollment to 3 years follow-up period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start5 Sep 2024
- Primary completionSep 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for CholeraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Sanger Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07685574
- Sponsor's protocol ID
- PR-24004
- Status last verified
- Jul 2026
- First submitted
- 17 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ratnayake R, Peyraud N, Ciglenecki I, Gignoux E, Lightowler M, Azman AS, Gakima P, Ouamba JP, Sagara JA, Ndombe R, Mimbu N, Ascorra A; Epicentre and MSF CATI Working Group; Welo PO, Mukamba Musenga E, Miwanda B, Boum Y 2nd, Checchi F, Edmunds WJ, Luquero F, Porten K, Finger F. Effectiveness of case-area targeted interventions including vaccination on the control of epidemic cholera: protocol for a prospective observational study. BMJ Open. 2022 Jul 6;12(7):e061206. doi: 10.1136/bmjopen-2022-061206.
PubMed 35793924Kanungo S, Desai SN, Nandy RK, Bhattacharya MK, Kim DR, Sinha A, Mahapatra T, Yang JS, Lopez AL, Manna B, Bannerjee B, Ali M, Dhingra MS, Chandra AM, Clemens JD, Sur D, Wierzba TF. Flexibility of oral cholera vaccine dosing-a randomized controlled trial measuring immune responses following alternative vaccination schedules in a cholera hyper-endemic zone. PLoS Negl Trop Dis. 2015 Mar 12;9(3):e0003574. doi: 10.1371/journal.pntd.0003574. eCollection 2015 Mar.
PubMed 25764513Ateudjieu J, Yakum MN, Goura AP, Tembei Ayok M, Guenou E, Kangmo Sielinou CB, Kiadjieu FF, Tsafack M, Douanla Koutio IM, Tchio-Nighie KH, Tchokomeni H, Ntsekendio PN, Sack DA. An innovative approach in monitoring oral cholera vaccination campaign: integration of a between-round survey. BMC Public Health. 2022 Feb 5;22(1):238. doi: 10.1186/s12889-022-12610-5.
PubMed 35123444Qadri F, Wierzba TF, Ali M, Chowdhury F, Khan AI, Saha A, Khan IA, Asaduzzaman M, Akter A, Khan A, Begum YA, Bhuiyan TR, Khanam F, Chowdhury MI, Islam T, Chowdhury AI, Rahman A, Siddique SA, You YA, Kim DR, Siddik AU, Saha NC, Kabir A, Cravioto A, Desai SN, Singh AP, Clemens JD. Efficacy of a Single-Dose, Inactivated Oral Cholera Vaccine in Bangladesh. N Engl J Med. 2016 May 5;374(18):1723-32. doi: 10.1056/NEJMoa1510330.
PubMed 27144848Azman AS, Luquero FJ, Ciglenecki I, Grais RF, Sack DA, Lessler J. Correction: The Impact of a One-Dose versus Two-Dose Oral Cholera Vaccine Regimen in Outbreak Settings: A Modeling Study. PLoS Med. 2016 Mar 11;13(3):e1001989. doi: 10.1371/journal.pmed.1001989. eCollection 2016 Mar. No abstract available.
PubMed 26966905Sarker MHR, Das SK, Sujon H, Moriyama M, Rahman MM, Uzzaman MN, Banu S, Shahid AS, Das J, Khan SH, Chisti MJ, Faruque A, Ahmed T. Changing Water-Sanitation Determinants of Cholera over Two Decades in Bangladesh. Am J Trop Med Hyg. 2023 Jun 5;109(2):368-375. doi: 10.4269/ajtmh.22-0575. Print 2023 Aug 2.
PubMed 37277103Jones FK, Bhuiyan TR, Muise RE, Khan AI, Slater DM, Hutt Vater KR, Chowdhury F, Kelly M, Xu P, Kovac P, Biswas R, Kamruzzaman M, Ryan ET, Calderwood SB, LaRocque RC, Lessler J, Charles RC, Leung DT, Qadri F, Harris JB, Azman AS. Identifying Recent Cholera Infections Using a Multiplex Bead Serological Assay. mBio. 2022 Dec 20;13(6):e0190022. doi: 10.1128/mbio.01900-22. Epub 2022 Oct 26.
PubMed 36286520Rahman M, Sack DA, Mahmood S, Hossain A. Rapid diagnosis of cholera by coagglutination test using 4-h fecal enrichment cultures. J Clin Microbiol. 1987 Nov;25(11):2204-6. doi: 10.1128/jcm.25.11.2204-2206.1987.
PubMed 3693549Bwire G, Orach CG, Abdallah D, Debes AK, Kagirita A, Ram M, Sack DA. Alkaline peptone water enrichment with a dipstick test to quickly detect and monitor cholera outbreaks. BMC Infect Dis. 2017 Nov 21;17(1):726. doi: 10.1186/s12879-017-2824-8.
PubMed 29157211Chowdhury F, Aziz AB, Ahmmed F, Ahmed T, Kang SS, Im J, Park J, Tadesse BT, Islam MT, Kim DR, Hoque M, Pak G, Khanam F, McMillan NAJ, Liu X, Zaman K, Khan AI, Kim JH, Marks F, Qadri F, Clemens JD. The interplay between WASH practices and vaccination with oral cholera vaccines in protecting against cholera in urban Bangladesh: Reanalysis of a cluster-randomized trial. Vaccine. 2023 Mar 31;41(14):2368-2375. doi: 10.1016/j.vaccine.2023.02.054. Epub 2023 Mar 8.
PubMed 36898931Qadri 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.
PubMed 26164097Azman AS, Parker LA, Rumunu J, Tadesse F, Grandesso F, Deng LL, Lino RL, Bior BK, Lasuba M, Page AL, Ontweka L, Llosa AE, Cohuet S, Pezzoli L, Sodjinou DV, Abubakar A, Debes AK, Mpairwe AM, Wamala JF, Jamet C, Lessler J, Sack DA, Quilici ML, Ciglenecki I, Luquero FJ. Effectiveness of one dose of oral cholera vaccine in response to an outbreak: a case-cohort study. Lancet Glob Health. 2016 Nov;4(11):e856-e863. doi: 10.1016/S2214-109X(16)30211-X.
PubMed 27765293Finger F, Bertuzzo E, Luquero FJ, Naibei N, Toure B, Allan M, Porten K, Lessler J, Rinaldo A, Azman AS. The potential impact of case-area targeted interventions in response to cholera outbreaks: A modeling study. PLoS Med. 2018 Feb 27;15(2):e1002509. doi: 10.1371/journal.pmed.1002509. eCollection 2018 Feb.
PubMed 29485987Deen J, von Seidlein L. The case for ring vaccinations with special consideration of oral cholera vaccines. Hum Vaccin Immunother. 2018;14(8):2069-2074. doi: 10.1080/21645515.2018.1462068. Epub 2018 May 11.
PubMed 29630444Qadri F, Ali M, Lynch J, Chowdhury F, Khan AI, Wierzba TF, Excler JL, Saha A, Islam MT, Begum YA, Bhuiyan TR, Khanam F, Chowdhury MI, Khan IA, Kabir A, Riaz BK, Akter A, Khan A, Asaduzzaman M, Kim DR, Siddik AU, Saha NC, Cravioto A, Singh AP, Clemens JD. Efficacy of a single-dose regimen of inactivated whole-cell oral cholera vaccine: results from 2 years of follow-up of a randomised trial. Lancet Infect Dis. 2018 Jun;18(6):666-674. doi: 10.1016/S1473-3099(18)30108-7. Epub 2018 Mar 14.
PubMed 29550406
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case-area Targeted Interventions (CATIs) Among Household Contacts and Neighbouring Households After Defining Cholera Hotspot Areas in Bangladesh: The Effectiveness of OCV and Potential Impact on Cholera Control
- ClinicalTrials.gov ID
- NCT07685574
- Acronym / sponsor ID
- PR-24004
- Conditions
- Cholera, Methodology Study
- Keywords
- Cholera, CATI, Cholera Vaccine, Bangladesh
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68,400 participants (estimated)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Collaborators
- Wellcome Sanger Institute
- Study start
- 5 Sep 2024 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the effectiveness of the CATI approach among household contacts in the reduction of cumulative incidence of cholera and explore the genome analysis and immune response of V. cholerae antigen from different hotspots in Dhaka city, cholera cases will be enrolled by rapid diagnostic test (RDT) from the diarrhoeal patients coming to icddr,b Dhaka hospital. Hotspots will be defined as the households (HHs) surrounding the RDT-positive cholera case (around 20-40m radius). The 'Case area targeted interventions' (CATI) will be given by administrating Oral Cholera Vaccine (OCV) with either one dose or two doses of OCV 1 month apart among household contacts (≥1-year age and non-pregnant women) and contacts of the contacts residing in the adjacent HHs. The passive surveillance for cholera will be followed using the icddr,b hospital, and other health facilities. Data on each individual's states of the clusters (e.g., susceptible, exposed, infectious, or recovered) will be tracked throughout the 3 years study follow-up.
Detailed description
Background (brief):
- Burden: Annually, 2.8 million cases and 95,000 deaths due to cholera are estimated to occur in cholera-endemic countries of Asia, Latin and Central America, and sub-Saharan Africa. The risk of cholera infection within the household and also around the households of cholera cases is higher than in the overall population. Outbreaks of cholera are unpredictable and can occur both in endemic settings and nonendemic areas depending on environmental conditions, climate change, or any humanitarian crisis where sanitary infrastructure is being disrupted. New phenotypes and genotypes of V. cholerae strains are constantly evolving with outbreaks, resulting in an increased risk of antimicrobial resistance (AMR).
- Knowledge gap: Standard cholera outbreak response and traditional vaccination campaign is time consuming, costly and usually delayed. A rapid response comprising an early detection of cholera case, hotspot identification and delivery of a rapid response to households around the case could reduce the transmission of disease. But it is not established that whether this early detection of cases and rapid intervention will reduce cholera transmission, also what number of oral cholera vaccine (OCV) will effectively reduce the transmission.
- Relevance: Availability of OCV is scarce but necessary for rapid response as it an effective short-term single intervention to shortened the epidemic period and cholera cases. This study aims to evaluate the effectiveness of the CATI approach (single/two doses at 1-month intervals) among household contacts and their neighbours in the reduction of the incidence of cholera
Hypothesis: Case area targeted intervention with OCV reduce the incidence of cholera after defining cholera hotspot.
Objectives: This study aims to evaluate the effectiveness of the CATI approach (OCV- one dose, two doses at one-month interval) among household contacts in the reduction of cumulative incidence of cholera and explore the genome analysis and immune response of V. cholerae antigen from different hotspots in Dhaka city.
Methods: The investigators will enroll cholera cases (index) by rapid diagnostic test (RDT) from the diarrhoeal patients coming to icddr,b Dhaka Hospital in and around Dhaka city based on our inclusion and exclusion criteria. Hotspots will be defined as the households (HHs) surrounding the RDT-positive cholera case (around 20-40m radius). The CATIs will be given by administrating OCV with either one dose or two doses of OCV 1 month apart among household contacts (≥1-year age and non-pregnant women) and contacts of the contacts residing in the adjacent HHs. The investigators will enrol on average 150 participants in each cluster of the index cases on the same day of the enrolment within the nearest geographic boundary (around 20-40m radius). Passive surveillance for cholera will be followed using the icddr,b hospital, and other selected health facilities. Data on each individual's states of the clusters (e.g., susceptible, exposed, infectious, or recovered) will be tracked throughout the 3 years study follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A) the intervention arm receiving a single dose | Experimental | Biological: Cholvaxdose (<5 years old children will receive two doses of OCV at 14 days interval according to the WHO guideline) |
| B) the intervention arm receiving two doses at 1-month interval | Experimental | Biological: Cholvax |
| C) no intervention or control arm | No intervention | – |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Some to severe dehydrated diarrheal patient
- Provide signed informed consent form
- Aged ≥1 year and non-pregnant
- Meeting the definition of IHC and NHC
- Provide signed informed consent form
Key exclusion criteria (7 listed)
- 1. Resident in a ward already covered by OCV since 2015
- Vaccination Eligibility
- History of taking OCV
- Currently suffering from diarrhea
- < 1 year of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CholvaxProduced in Bangladesh and Licenced by the Directorate of Drug Administration (DGDA) for use in Bangladesh | Biological | A) the intervention arm receiving a single dose, B) the intervention arm receiving two doses at 1-month interval |
Primary outcome
Number of culture-confirmed V. cholerae
Time frame: From enrollment to 3 years follow-up period.
Number of culture-confirmed V. cholerae within 3 years. Stool samples from participants with diarrhea will be cultured for V. cholerae.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Background: PubMed 35793924Ratnayake R, Peyraud N, Ciglenecki I, Gignoux E, Lightowler M, Azman AS, Gakima P, Ouamba JP, Sagara JA, Ndombe R, Mimbu N, Ascorra A; Epicentre and MSF CATI Working Group; Welo PO, Mukamba Musenga E, Miwanda B, Boum Y 2nd, Checchi F, Edmunds WJ, Luquero F, Porten K, Finger F. Effectiveness of case-area targeted interventions including vaccination on the control of epidemic cholera: protocol for a prospective observational study. BMJ Open. 2022 Jul 6;12(7):e061206. doi: 10.1136/bmjopen-2022-061206.
- Background: PubMed 25764513Kanungo S, Desai SN, Nandy RK, Bhattacharya MK, Kim DR, Sinha A, Mahapatra T, Yang JS, Lopez AL, Manna B, Bannerjee B, Ali M, Dhingra MS, Chandra AM, Clemens JD, Sur D, Wierzba TF. Flexibility of oral cholera vaccine dosing-a randomized controlled trial measuring immune responses following alternative vaccination schedules in a cholera hyper-endemic zone. PLoS Negl Trop Dis. 2015 Mar 12;9(3):e0003574. doi: 10.1371/journal.pntd.0003574. eCollection 2015 Mar.
- Background: PubMed 35123444Ateudjieu J, Yakum MN, Goura AP, Tembei Ayok M, Guenou E, Kangmo Sielinou CB, Kiadjieu FF, Tsafack M, Douanla Koutio IM, Tchio-Nighie KH, Tchokomeni H, Ntsekendio PN, Sack DA. An innovative approach in monitoring oral cholera vaccination campaign: integration of a between-round survey. BMC Public Health. 2022 Feb 5;22(1):238. doi: 10.1186/s12889-022-12610-5.
- Background: PubMed 27144848Qadri F, Wierzba TF, Ali M, Chowdhury F, Khan AI, Saha A, Khan IA, Asaduzzaman M, Akter A, Khan A, Begum YA, Bhuiyan TR, Khanam F, Chowdhury MI, Islam T, Chowdhury AI, Rahman A, Siddique SA, You YA, Kim DR, Siddik AU, Saha NC, Kabir A, Cravioto A, Desai SN, Singh AP, Clemens JD. Efficacy of a Single-Dose, Inactivated Oral Cholera Vaccine in Bangladesh. N Engl J Med. 2016 May 5;374(18):1723-32. doi: 10.1056/NEJMoa1510330.
- Background: PubMed 26966905Azman AS, Luquero FJ, Ciglenecki I, Grais RF, Sack DA, Lessler J. Correction: The Impact of a One-Dose versus Two-Dose Oral Cholera Vaccine Regimen in Outbreak Settings: A Modeling Study. PLoS Med. 2016 Mar 11;13(3):e1001989. doi: 10.1371/journal.pmed.1001989. eCollection 2016 Mar. No abstract available.
- Background: PubMed 37277103Sarker MHR, Das SK, Sujon H, Moriyama M, Rahman MM, Uzzaman MN, Banu S, Shahid AS, Das J, Khan SH, Chisti MJ, Faruque A, Ahmed T. Changing Water-Sanitation Determinants of Cholera over Two Decades in Bangladesh. Am J Trop Med Hyg. 2023 Jun 5;109(2):368-375. doi: 10.4269/ajtmh.22-0575. Print 2023 Aug 2.
- Background: PubMed 36286520Jones FK, Bhuiyan TR, Muise RE, Khan AI, Slater DM, Hutt Vater KR, Chowdhury F, Kelly M, Xu P, Kovac P, Biswas R, Kamruzzaman M, Ryan ET, Calderwood SB, LaRocque RC, Lessler J, Charles RC, Leung DT, Qadri F, Harris JB, Azman AS. Identifying Recent Cholera Infections Using a Multiplex Bead Serological Assay. mBio. 2022 Dec 20;13(6):e0190022. doi: 10.1128/mbio.01900-22. Epub 2022 Oct 26.
- Background: PubMed 3693549Rahman M, Sack DA, Mahmood S, Hossain A. Rapid diagnosis of cholera by coagglutination test using 4-h fecal enrichment cultures. J Clin Microbiol. 1987 Nov;25(11):2204-6. doi: 10.1128/jcm.25.11.2204-2206.1987.
- Background: PubMed 29157211Bwire G, Orach CG, Abdallah D, Debes AK, Kagirita A, Ram M, Sack DA. Alkaline peptone water enrichment with a dipstick test to quickly detect and monitor cholera outbreaks. BMC Infect Dis. 2017 Nov 21;17(1):726. doi: 10.1186/s12879-017-2824-8.
- Background: PubMed 36898931Chowdhury F, Aziz AB, Ahmmed F, Ahmed T, Kang SS, Im J, Park J, Tadesse BT, Islam MT, Kim DR, Hoque M, Pak G, Khanam F, McMillan NAJ, Liu X, Zaman K, Khan AI, Kim JH, Marks F, Qadri F, Clemens JD. The interplay between WASH practices and vaccination with oral cholera vaccines in protecting against cholera in urban Bangladesh: Reanalysis of a cluster-randomized trial. Vaccine. 2023 Mar 31;41(14):2368-2375. doi: 10.1016/j.vaccine.2023.02.054. Epub 2023 Mar 8.
- Background: PubMed 26164097Qadri 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.
- Background: PubMed 27765293Azman AS, Parker LA, Rumunu J, Tadesse F, Grandesso F, Deng LL, Lino RL, Bior BK, Lasuba M, Page AL, Ontweka L, Llosa AE, Cohuet S, Pezzoli L, Sodjinou DV, Abubakar A, Debes AK, Mpairwe AM, Wamala JF, Jamet C, Lessler J, Sack DA, Quilici ML, Ciglenecki I, Luquero FJ. Effectiveness of one dose of oral cholera vaccine in response to an outbreak: a case-cohort study. Lancet Glob Health. 2016 Nov;4(11):e856-e863. doi: 10.1016/S2214-109X(16)30211-X.
- Global Task Force on Cholera Control: Ending Cholera-A Global Roadmap to 2030Link provided by the sponsor.
- Shortage of cholera vaccines leads to temporary suspension of two-dose strategy, as cases rise worldwideLink provided by the sponsor.
- Millions at risk from cholera due to lack of clean water, soap and toilets, and shortage of cholera vaccine: The International Coordinating Group (ICG) on Vaccine Provision calls for urgent fast-tracking of life-saving measuresLink provided by the sponsor.
- Technology Transfer and Voluntary Licensing to Address the Global Cholera Vaccine Shortage and Africa's Vaccine Production GoalsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Not yet recruitingPhase 2
Ondansetron to Prevent Oral Rehydration Failure in Children With Cholera
Cholera (Disorder)
Not yet recruitingPhase 4
Study on Changes in Gut Microbiota, Inflammatory Factors, and Bowel Habits Following Oral Administration of Recombinant B-subunit/Whole Cell Cholera Vaccine in a Community Population
Bowel Habits, Gut Microbiomes
RecruitingPhase 1
Phase 1b Ascending Dose Study of PanChol in Healthy Volunteers
Cholera Vaccination Reaction
RecruitingPhase 4
CVD 38000: Study of Responses to Vaccination With Typhoid and/or Cholera
Typhoid and/or Cholera Vaccination
Enrolling by invitationPhase 4
A Post-marketing Observational Study of Oral Cholera Vaccine
Diarrhea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cholvax in people with Cholera and Methodology Study, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Fahima Chowdhury, MBBS, MPH, PhD (+8801730016458, fchowdhury@icddrb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of culture-confirmed V. cholerae (time frame: From enrollment to 3 years follow-up period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07685574, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.