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Vaccine- and Infection-derived Correlates of Protection for Cholera

RecruitingNAAges 2 Years - 80 YearsAllMassachusetts General Hospital
NCT06455852 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Background: Vibrio cholerae causes millions of cholera cases and thousands of deaths annually. Vaccines are in short supply. There is no agreement on how to introduce new vaccines or evaluate their effectiveness, and the lack of 'correlates of protection' (CoPs) against cholera is a major obstacle to vaccine development. CoPs are markers of effective immune response to vaccination. While other infectious diseases have well established CoPs, none are widely accepted for cholera. Relevance: Lack of accepted CoPs impedes development of cholera vaccines, limiting progress toward improved vaccines, slowing the licensure of new vaccines, and contributing to the current vaccine shortage; an immediate obstacle to achieving reductions in cholera-related illness and deaths. The identification of new CoPs will speed the development of improved cholera vaccines and provide a pathway to their licens

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📋 Eligibility rules (as published)
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.
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What it tests

  • oral cholera vaccine or typhoid conjugate vaccine
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Where

1 site
Icddr,B
Dhaka, Bangladesh
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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