Identifying immune markers for cholera vaccine effectiveness
Official title: Vaccine- and Infection-derived Correlates of Protection for Cholera
Run by Massachusetts General Hospital · NCT06455852 · Data updated 2026-11-12
This study is testing if certain immune markers can show how well the cholera vaccine works in people receiving it compared to those getting a different vaccine.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 2 Years to 80 Years |
| Sex | All |
| Enrollment | 1221 (estimated) |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Dhaka) |
| Status | Recruiting |
| Started | March 2, 2025 |
| Main results expected | December 31, 2028 |
| Study ends | May 1, 2029 |
| Registry record updated | April 8, 2026 |
| Trial ID | NCT06455852 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals aged 2 to 80 years without major co-morbid conditions.
✕Probably not a fit
Patients with recent gastrointestinal issues or those who have received other enteric vaccines in the past eight weeks may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to identify correlates of protection (CoPs) for cholera, which are essential markers indicating an effective immune response to vaccination. Given the high incidence of cholera and the current vaccine shortages, establishing CoPs will facilitate the development and licensure of new cholera vaccines. Participants will receive either an oral cholera vaccine or a typhoid conjugate vaccine, and their immune responses will be monitored over a two-year period. The study seeks to address the critical gap in knowledge regarding effective immune responses to cholera vaccination.
Why it matters
Potential benefit: If successful, this study could lead to the development of more effective cholera vaccines, ultimately reducing illness and deaths from cholera.
How similar studies have gone: While other infectious diseases have established correlates of protection, cholera has not, making this approach novel and untested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria 1. Ages 2 - 80 years. 2. Informed consent from study participants and guardian in case of children (2-17 years) and assent from children aged 11-17 years. 3. Intention to participate in the study for a 2-year period. 4. No major co-morbid conditions, per the supervising clinician investigator, including underlying immunodeficiency, diabetes, liver diseases, renal disease, cardiac disease, and/or active malignancy. Exclusion criteria 1. Suffering from diarrhoea or abdominal pain or vomiting in the past 24 hours or diarrhoea lasting for more than 2 weeks in the past 6 months. 2. History of taking another oral cholera vaccine. 3. History of taking any other live or killed enteric vaccine in the last 8 weeks.
Where it's running
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Icddr,B
Dhaka, Bangladesh Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Cholera control around a case area using targeted vaccination (CATI) in Dhaka
This study tests whether vaccinating household contacts around a cholera case in Dhaka can reduce transmission of the disease.
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Testing a new approach to reduce cholera and diarrhea in households
This study is testing a new program to see if better water and hygiene practices can help reduce cholera and diarrhea in homes with young children.
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Targeted water, sanitation, and hygiene intervention for cholera prevention
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Preventing cholera through targeted water and hygiene interventions
This study is testing a new way to improve water and hygiene practices for families of diarrhea patients in the Democratic Republic of the Congo to see if it can help prevent cholera.
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Assessing the impact of cholera vaccination in endemic areas
This study is testing if giving a cholera vaccine to lots of people in the Democratic Republic of the Congo can help keep cholera under control for at least two years.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.