NCT07509047

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 390 (estimated)
• Sponsor: International Vaccine Institute · Academic / Other
• Sex: All
• Age: 1 Year – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is phase II, randomized, controlled, safety and immunogenicity study of one and two doses of the of CCV 25 μg (with and without alum) in cholera-endemic region. A total of 390 eligible participants will be recruited in the study into 3 age cohorts. This will be a randomized, placebo-controlled, observer blind study in adults aged 18 to 45 years (cohort A) and children aged 5 to 17 years (cohort B) followed by a randomized, active-controlled, partial open label study in children aged 1 to 4 years (cohort C). The DSMB must review the safety data of each cohort and approve study continuation before investigational product administration of the next younger cohort is initiated (age descending study scheme). In cohort A, 50 adult participants aged 18 to 45 years will be randomly divided into 5 arms to receive the assigned investigational product as follows: Arm A1 (n=10): one dose of CCV 25 μg with alum and one dose of placebo at 6 months interval Arm A2 (n=10): one dose of CCV 25 μg without alum and one dose of placebo at 6 months interval Arm A3 (n=10): two doses of CCV 25 μg with alum at 6 months interval Arm A4 (n=10): two doses of CCV 25 μg without alum at 6 months interval Arm A5 (n=10): two doses of placebo at 6 months interval In cohort B, 90 children aged 5 to 17 years will be randomly divided into 5 arms to receive the assigned investigational product as follows: Arm B1 (n=20): one dose of CCV 25 μg with alum and one dose of placebo at 6 months interval Arm B2 (n=20): one dose of CCV 25 μg without alum and one dose of placebo at 6 months interval Arm B3 (n=20): two doses of CCV 25 μg with alum at 6 months interval Arm B4 (n=20): two doses of CCV 25 μg without alum at 6 months interval Arm B5 (n=10): two doses of placebo at 6 months interval In cohort C, 250 children aged 1 to 4 years will be randomly divided into 10 arms to receive the assigned investigational product as follows: Arm C1 (n=30): one dose of CCV 25 μg with alum and one dose of placebo at 6 months interval Arm C2 (n=30): one dose of CCV 25 μg without alum and one dose of placebo at 6 months interval Arm C3 (n=30): two doses of CCV 25 μg with alum at 6 months interval Arm C4 (n=30): two doses of CCV 25 μg without alum at 6 months interval Arm C5 (n=20): two doses of placebo at 6 months interval Arm C6 (n=30): two doses of Euvichol®-Plus at 2 weeks interval Arm C7 (n=20): one dose of CCV 25 μg with alum and one dose of Euvichol®-Plus at 6 months interval Arm C8 (n=20): one dose of CCV 25 μg without alum and one dose of Euvichol®-Plus at 6 months interval Arm C9 (n=20): one dose of Euvichol®-Plus and one dose of CCV 25 μg with alum at 6 months interval Arm C10 (n=20): one dose of Euvichol®-Plus and one dose of CCV 25 μg without alum at 6 months interval Route of vaccination: CCV 25 μg (with or without alum) and placebo are administered by intramuscular (IM) injection. Euvichol®-Plus is administered orally.

Conditions

• Cholera Vaccination

Interventions

Type	Name	Description
BIOLOGICAL	OSP:rTTHc CCV 25 ㎍ with Aluminum phosphate	OSP:rTTHc Cholera Conjugate with Aluminum phosphate Cohort Arms A1, A3, B1, B3, C1, C3, C10
BIOLOGICAL	OSP:rTTHc CCV 25 ㎍ without Aluminum phosphate	OSP:rTTHc Cholera Conjugate without Aluminum phosphate Cohort Arms A2, A4, B2, B4, C2, C4
BIOLOGICAL	Euvichol®-Plus	V. cholerae O1 and O139 bivalent inactivated oral cholera vaccine cohort Arm C6
OTHER	Placebo	Sterile 0.9% sodium chloride cohort Arms A5, B5, C5
BIOLOGICAL	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
BIOLOGICAL	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

Timeline

• Start date: 2026-01-13
• Primary completion: 2027-03-01
• Completion: 2027-12-01
• First posted: 2026-04-03
• Last updated: 2026-04-03

Locations

1 site across 1 country: Kenya