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
Status: Recruiting
Location: See location...
Intervention Type: Biological, Other
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 45
Healthy Volunteers: t
View:
• 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
Locations
Other Locations
Kenya
KAVI-Institute of Clinical Research, University
RECRUITING
Nairobi
Contact Information
Primary
Naveena D'Cor, MD
naveena.dcor@ivi.int
+82 2 8811 000
Backup
Tarun Saluja, MD
Tarun.Saluja@ivi.int
+82 2 8811 000
Time Frame
Start Date:2026-01-13
Estimated Completion Date:2027-12
Participants
Target number of participants:390
Treatments
Experimental: OSP:rTTHc CCV 25 ㎍ with Aluminum phosphate
0.5 mL per dose; dosing schedule/duration: 1 dose or 2 doses at 168-days interval administered intramuscularly
Experimental: OSP:rTTHc CCV 25 ㎍ without Aluminum phosphate
0.5 mL per dose; dosing schedule/duration: 1 dose or 2 doses at 168-days interval administered intramuscularly
Active_comparator: Euvichol®-Plus
1.5 mL per dose; dosing schedule/duration: 2 doses at 14-days interval administered orally