Clinical trial Recruiting at 1 site Interventional Ages 2 to 80

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 typeInterventional
Ages2 Years to 80 Years
SexAll
Enrollment1221 (estimated)
SponsorMassachusetts General Hospital
Academic / other
Locations1 site (Dhaka)
StatusRecruiting
StartedMarch 2, 2025
Main results expectedDecember 31, 2028
Study endsMay 1, 2029
Registry record updatedApril 8, 2026
Trial IDNCT06455852 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

  • Icddr,B
    Dhaka, Bangladesh
    Recruiting

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.