RecruitingCholera Vaccination
Age-descending Study to Evaluate the Safety and Immunogenicity of the Cholera Conjugate Vaccine in Adults and Children
Eligible age
1–45 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
Yes
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: International Vaccine Institute
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
Source: ClinicalTrials.gov · NCT07509047 · last updated 2026-04-03