RecruitingPhase 2

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

Kenya390 participantsStarted 2026-01-13

Plain-language 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.

Who can participate

Age range1 Year – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Individuals aged 1 to 45 years at consent
✓. Participants/ Participants' legally authorized representative (LAR) willing to provide written informed consent to participate in the study voluntarily
✓. Participants who can comply with the study requirements
✓. Individuals in good health as determined by the outcome of medical history, physical examination, and the clinical judgment of the investigator

Exclusion criteria

✕. Known history or allergy to investigational vaccine components or other medications, or any other allergies
✕. Individuals with major congenital abnormalities
✕. Known history of immune function disorders including immunodeficiency diseases (known HIV infection¥ or other immune function disorders)
✕. 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.
✕. 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
✕. 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

What they're measuring

Seroconversion of Serum vibriocidal antibody titers responses to V. cholerae O1 Inaba and O1 Ogawa at 28 days after one dose vaccination of CCV 25 μg (with or without alum) in adults (aged 18 to 45 years) and in children (aged 1 to 17 years).

Timeframe: Baseline and at 28 days post the first dose of either CCV with alum, CCV without alum or placebo

GMT of Serum vibriocidal antibody titers to V. cholerae O1 Inaba and O1 Ogawa after one dose of CCV 25 μg (with or without alum) in adults (aged 18 to 45 years) and in children (aged 1 to 17 years)

Timeframe: Baseline and at 28 days post the first dose of either CCV with alum, CCV without alum or placebo

Seroconversion of vibriocidal titers against V. cholerae O1 Inaba and O1 Ogawa after two doses of Euvichol®-Plus in children aged 1 to 4 years

Timeframe: Baseline and at 14 days post two doses of Euvichol®-Plus

GMT of vibriocidal titers against V. cholerae O1 Inaba and O1 Ogawa after two doses of Euvichol®-Plus in children aged 1 to 4 years

Timeframe: Baseline and at 14 days after two doses of Euvichol®-Plus

Seroconversion of Serum OSP IgG antibody titers against V. cholerae O1 Inaba after one dose vaccination of CCV 25 μg (with or without alum) in adults (aged 18 to 45 years) and in children (aged 1 to 17 years).

Timeframe: Baseline and at 28 days post the first dose of either CCV with alum, CCV without alum or placebo

Trial details

NCT IDNCT07509047

SponsorInternational Vaccine Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03

Contact for this trial

Naveena D'Cor, MD

+82 2 8811 000 naveena.dcor@ivi.int

View on ClinicalTrials.gov More Cholera Vaccination trials

Plain-language summary

Who can participate

Age range1 Year – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Individuals aged 1 to 45 years at consent
✓. Participants/ Participants' legally authorized representative (LAR) willing to provide written informed consent to participate in the study voluntarily
✓. Participants who can comply with the study requirements
✓. Individuals in good health as determined by the outcome of medical history, physical examination, and the clinical judgment of the investigator

Exclusion criteria

✕. Known history or allergy to investigational vaccine components or other medications, or any other allergies
✕. Individuals with major congenital abnormalities
✕. Known history of immune function disorders including immunodeficiency diseases (known HIV infection¥ or other immune function disorders)
✕. 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.
✕. 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
✕. 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