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

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.

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

Sponsors & Collaborators

• EuBiologics Co.,Ltd

  collaborator INDUSTRY

• Massachusetts General Hospital

  collaborator OTHER

• International Vaccine Institute

  lead OTHER

Principal Investigators

• Anh Wartel, MD · +82 2 8811 274

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

19 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-12-05

Primary Completion

2023-09-08

Completion

2024-01-23

Countries

• South Korea

Study Locations