NCT05559983 - Dose Escalation Study to Evaluate the Safety and Immunogenicity of the Cholera Conjugate Vaccine in Healthy Adults | Biotech Hunter

Enrollment

150

Participants

Timeline

Start Date

December 5, 2022

Primary Completion Date

September 8, 2023

Study Completion Date

January 23, 2024

Conditions

Cholera Vaccination Reaction

Interventions

BIOLOGICAL

OSP:rTTHc Cholera Conjugate Vaccine Cohort A

OSP:rTTHc Cholera Conjugate Vaccine without Aluminum phosphate with dose formulation 5 µg of OSP:rTTHc

BIOLOGICAL

OSP:rTTHc Cholera Conjugate Vaccine with Aluminum phosphate adjuvant Cohort A

OSP:rTTHc Cholera Conjugate Vaccine with Aluminum phosphate with dose formulation 5 µg of OSP:rTTHc

OTHER

Placebo Cohort A

Sterile 0.9% sodium chloride

BIOLOGICAL

OSP:rTTHc Cholera Conjugate Vaccine Cohort B

OSP:rTTHc Cholera Conjugate Vaccine without Aluminum phosphate with dose formulation 10 µg of OSP:rTTHc

BIOLOGICAL

OSP:rTTHc Cholera Conjugate Vaccine with Aluminum phosphate adjuvant Cohort B

OSP:rTTHc Cholera Conjugate Vaccine with Aluminum phosphate with dose formulation 10 µg of OSP:rTTHc

OTHER

Placebo Cohort B

Sterile 0.9% sodium chloride

BIOLOGICAL

OSP:rTTHc Cholera Conjugate Vaccine Cohort C

OSP:rTTHc Cholera Conjugate Vaccine without Aluminum phosphate with dose formulation 25 µg of OSP:rTTHc

BIOLOGICAL

OSP:rTTHc Cholera Conjugate Vaccine with Aluminum phosphate adjuvant Cohort C

OSP:rTTHc Cholera Conjugate Vaccine with Aluminum phosphate with dose formulation 25 µg of OSP:rTTHc

OTHER

Placebo Cohort C

Sterile 0.9% sodium chloride

Trial Locations (3)

The Catholic University of Korea Seoul St. Mary's Hospital, Seoul

CHA Bundang Medical Center (CBMC) of CHA University, Seoul

Soon Chun Hyang University Hospital, Seoul