NCT07509047 Age-descending Study to Evaluate the Safety and Immunogenicity of the Cholera Conjugate Vaccine in Adults and Children

Eligibility & Interventions

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 390 participants in total. It began in 2026-01-13 with a primary completion date of 2027-03.

Brief Summary

This phase II study is intended to determine the immunogenicity and safety of single dose and two doses of OSP:rTTHc cholera conjugate vaccine (CCV) with or without alum adjuvant. The study will guide the future dosing schedule and formulation of CCV (with or without Aluminum phosphate adjuvant) expected to be needed in adults and children in cholera-endemic region.

Eligibility Criteria

Inclusion Criteria: 1. Individuals aged 1 to 45 years at consent 2. Participants/ Participants' legally authorized representative (LAR) willing to provide written informed consent to participate in the study voluntarily 3. Participants who can comply with the study requirements 4. Individuals in good health as determined by the outcome of medical history, physical examination, and the clinical judgment of the investigator Exclusion Criteria: 1. Known history or allergy to investigational vaccine components or other medications, or any other allergies 2. Individuals with major congenital abnormalities 3. Known history of immune function disorders including immunodeficiency diseases (known HIV infection¥ or other immune function disorders) 4. Use of systemic steroids within past 6 months (\>10 mg/day prednisone equivalent for periods exceeding 2 consecutive weeks), or receive chemotherapy, radiation therapy or other immunosuppressive drugs within the past 6 months. 5. Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the participant and interfere with the assessment of the study objectives 6. Individuals with behavioral or cognitive impairment or psychiatric disease or neural disorders that, in the opinion of the investigator, could interfere with the participant's ability to participate in the trial 7. Individuals with splenectomy 8. Individuals with known bleeding disorders 9. Receipt of blood, blood-derived products, or immunoglobulin products in the past 3 months 10. Individuals who have received other vaccines from 4 weeks prior to the first dose of test vaccination or planned to receive any vaccine within 4 weeks of the last dose of the investigational product. 11. Individuals with active or known previous Vibrio cholerae infection 12. Individuals with a history of severe diarrhea in the last 6 months requiring care at a medical facility lasting 24 hours or more 13. Individuals with prior receipt of a cholera vaccine in the last 5 years 14. Any female participant who is lactating or pregnant 15. Females of childbearing potential who do not agree to use an effective birth control method for at least 4 weeks before the screening and up to 12 weeks after the study vaccination. 16. Individuals enrolled in another clinical trial within 6 months prior to enrollment, concomitantly enrolled or scheduled to be enrolled in another trial during study period 17. Individuals who are research staff involved with the clinical trial or family/household members of research staff 18. As per Investigator's medical judgement, an individual could also be excluded from the study despite meeting all inclusion/exclusion criteria mentioned above 19. Children below 5 years old with Weight for Height Z score and/or Height for Age Z score of less than -2

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