Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07509047
PHASE2

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

Sponsor: International Vaccine Institute

View on ClinicalTrials.gov

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

Interventions

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

Locations (1)

KAVI-Institute of Clinical Research, University

Nairobi, Kenyatta National Hospital Complex, Kenya