Identifying immune markers for cholera vaccine effectiveness
Vaccine- and Infection-derived Correlates of Protection for Cholera
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1221 (estimated) |
| Ages | 2 Years to 80 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Dhaka) |
| Trial ID | NCT06455852 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 2 to 80 years without major co-morbid conditions.
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.
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 performed: While other infectious diseases have established correlates of protection, cholera has not, making this approach novel and untested.
Eligibility criteria
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 this trial is running
Dhaka
- Icddr,B — Dhaka, Bangladesh (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.