NCT05559983

Dose Escalation Study to Evaluate the Safety and Immunogenicity of the Cholera Conjugate Vaccine in Healthy Adults

A Phase I, Multicenter, Observer-Blinded, Randomized, Placebo-Controlled, Dose Escalation Trial to Evaluate the Safety and Immunogenicity of the OSP:rTTHc Cholera Conjugate Vaccine in 19 to 45 Years Old Healthy Korean Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: International Vaccine Institute · Academic / Other
• Sex: All
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This Phase I, first-in-human study is intended to primarily determine the safety of the dose range with or without Aluminum phosphate adjuvant expected to be needed for later clinical studies, to determine the nature of adverse reactions (i.e., safety profile) and to secondly assess the Aluminum phosphate humoral immune responses in non-endemic population to guide future dose selection.

Detailed description

A total of 150 eligible participants will be recruited in 3 sequential dose cohorts: low-dose 5 µg, medium-dose 10 µg, and high-dose 25 µg. In each dose cohorts, the participants will be randomized in a blinded manner into three arms (vaccine antigen with aluminum phosphate, vaccine antigen without Aluminum phosphate or placebo) in 2:2:1 ratio. All the participants will receive two intramuscular injections of 0.5 mL of the designated study vaccine or placebo on deltoid muscle, on Days 0 and 28. The DSMB will review the safety data and approve dose escalation before investigational product injection of the next cohort is initiated. The study primary objective is to evaluate the safety of the O Specific Polysaccharide recombinant Tetanus Toxoid Heavy Chain Fragment (OSP:rTTHc) cholera conjugate vaccine (CCV) after each dose vaccination. The secondary objectives are: * To evaluate the Antibody response to OSP IgG against V. cholerae O1 after each dose vaccination of OSP:rTTHc CCV/placebo compared to pre-vaccination. * To evaluate the serum vibriocidal antibody titers against V. cholerae O1 Inaba and V. cholerae O1 Ogawa 4 weeks after each dose vaccination of OSP:rTTHc CCV/placebo compared to pre-vaccination. The exploratory objectives are: * To describe the anti tetanus toxoid (anti-TT) Immunoglobulin G (IgG) 4 weeks after each dose vaccination of OSP:rTTHc CCV/placebo compared to pre-vaccination. * To describe memory B cell responses 4 and 28 weeks after first dose vaccination of OSP:rTTHc CCV/placebo compared to pre-vaccination.

Conditions

• Cholera Vaccination Reaction

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-12-05
• Primary completion: 2023-09-08
• Completion: 2024-01-23
• First posted: 2022-09-29
• Last updated: 2025-03-25

Locations

3 sites across 1 country: South Korea