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Age-descending Study to Evaluate the Safety and Immunogenicity of the Cholera Conjugate Vaccine in Adults and Children
Sponsor: International Vaccine Institute
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.
Official title: A Phase II, Randomized, Controlled, Age-descending Study in Adults and Children to Evaluate the Safety and Immunogenicity of the OSP:rTTHc Cholera Conjugate Vaccine in Cholera-endemic Region
Key Details
Gender
All
Age Range
1 Year - 45 Years
Study Type
INTERVENTIONAL
Enrollment
390
Start Date
2026-01-13
Completion Date
2027-12
Last Updated
2026-04-03
Healthy Volunteers
Yes
Conditions
Interventions
OSP:rTTHc CCV 25 ㎍ with Aluminum phosphate
OSP:rTTHc Cholera Conjugate with Aluminum phosphate Cohort Arms A1, A3, B1, B3, C1, C3, C10
OSP:rTTHc CCV 25 ㎍ without Aluminum phosphate
OSP:rTTHc Cholera Conjugate without Aluminum phosphate Cohort Arms A2, A4, B2, B4, C2, C4
Euvichol®-Plus
V. cholerae O1 and O139 bivalent inactivated oral cholera vaccine cohort Arm C6
Placebo
Sterile 0.9% sodium chloride cohort Arms A5, B5, C5
CCV with Aluminum, Euvichol®-Plus
1. OSP:rTTHc CCV 25 # with Aluminum phosphate OSP:rTTHc Cholera Conjugate with Aluminum phosphate 2. Euvichol®-Plus V. cholerae O1 and O139 bivalent inactivated oral cholera vaccine Cohort Arms C7, C9
CCV without Aluminum, Euvichol®-Plus
1. OSP:rTTHc CCV 25 # without Aluminum phosphate OSP:rTTHc Cholera Conjugate without Aluminum phosphate 2. Euvichol®-Plus V. cholerae O1 and O139 bivalent inactivated oral cholera vaccine Cohort Arms C8, C10
Locations (1)
KAVI-Institute of Clinical Research, University
Nairobi, Kenyatta National Hospital Complex, Kenya