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

March 21, 2025 updated by: International Vaccine Institute

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 06591
        • The Catholic University of Korea Seoul St. Mary's Hospital
      • Seoul, Korea, Republic of, 08826
        • CHA Bundang Medical Center (CBMC) of CHA University
      • Seoul, Korea, Republic of, 08826
        • Soon Chun Hyang University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Healthy Korean participants aged 19 to 45 years at consent
  2. Participants willing to provide written informed consent to participate study voluntarily
  3. Participants who can be followed up during the study period and can comply with the study requirements
  4. Individual in good health as determined by the outcome of medical history, physical examination, laboratory evaluations and the clinical judgment of the investigator
  5. Females of childbearing potential with negative pregnancy test result on the day of screening
  6. Females of childbearing potential who agree to use an effective birth control method* from the screening and p to 12 weeks after the second dose vaccination.
  7. Males who agree to use an effective birth control method* from the screening and up to 12 weeks after the second dose vaccination

Exclusion Criteria:

  1. Known history or allergy to investigational vaccine components and/or excipients or other medications, or any other allergies deemed by the investigator to increase the risk of an adverse event if they were to participate in the trial
  2. Individuals with major congenital abnormalities which in the opinion of investigator may affect the participant's participation in the study
  3. Known history of immune function disorders including immunodeficiency diseases (known HIV infection or other immune function disorders)
  4. Use of systemic steroids within past 6 months (>10 mg/day prednisone equivalent for periods exceeding 2 consecutive weeks), or receive chemotherapy, radiation therapy or other immunosuppressive drugs within the past 6 months.
  5. Individuals with behavioral or cognitive impairment or psychiatric disease or neural disorders that, in the opinion of the investigator, could interfere with the participant's ability to participate in the trial
  6. Individuals with splenectomy
  7. Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time resulting in contraindication for intramuscular injections/blood extractions
  8. Receipt of blood, blood-derived products, or immunoglobulin products in the past 3 months
  9. Individuals who have received other vaccines from 4 weeks prior to the first dose of test vaccination or planned to receive any vaccine within 4 weeks of the last dose of the investigational product
  10. Body mass index (BMI) ≥ 35 kg/m2
  11. Individuals with active or previous Vibrio cholerae infection
  12. Individuals with history of severe diarrhea requiring hospitalization or emergency room visit for the last 5 years
  13. Individuals with receipt of a cholera vaccine
  14. Individuals who lived in cholera endemic areas for more than 6 months for the past 10 years
  15. As per Investigator's medical judgement, an individual could be excluded from the study despite meeting all inclusion/exclusion criteria mentioned above
  16. Any female participant who is lactating*, pregnant or planning for pregnancy** during study period
  17. Individuals enrolled in another clinical trial or bioequivalence test during 6 months prior to enrollment, concomitantly enrolled or scheduled to be enrolled in another trial
  18. Individuals who are research staff involved with the clinical study or family/household members of research staff

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: OSP:rTTHc Cholera Conjugate Vaccine
2 doses @0.5 mL of test vaccine administered intramuscularly in deltoid region at 4 weeks apart
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 Cohort B
OSP:rTTHc Cholera Conjugate Vaccine without Aluminum phosphate with dose formulation 10 µg of OSP:rTTHc
Biological: OSP:rTTHc Cholera Conjugate Vaccine Cohort C
OSP:rTTHc Cholera Conjugate Vaccine without Aluminum phosphate with dose formulation 25 µg of OSP:rTTHc
Experimental: OSP:rTTHc Cholera Conjugate Vaccine with Aluminum phosphate adjuvant
2 doses @0.5 mL of test vaccine administered intramuscularly in deltoid region at 4 weeks apart
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
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
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
Placebo Comparator: Placebo
2 doses @0.5 mL of Sterile 0.9% sodium chloride administered intramuscularly in deltoid region at 4 weeks apart
Other: Placebo Cohort A
Sterile 0.9% sodium chloride
Other: Placebo Cohort B
Sterile 0.9% sodium chloride
Other: Placebo Cohort C
Sterile 0.9% sodium chloride

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Serious adverse events (SAEs) and adverse events of special interest (AESIs)
Time Frame: Entire study participation period (approximately 7 months)
Occurrence of any SAEs/AESIs from the time of the first dose of study vaccine
Entire study participation period (approximately 7 months)
Immediate adverse events
Time Frame: Within 30 minutes post each dose
Occurrence of immediate adverse events within 30 minutes from the time of each study vaccination.
Within 30 minutes post each dose
Solicited adverse events
Time Frame: Within 7 days post each dose
Occurrence of solicited injection site and solicited systemic adverse events from the time of each study vaccination through 7 days after each study vaccination
Within 7 days post each dose
Unsolicited adverse events
Time Frame: Within 28 days post each dose
Occurrence of unsolicited adverse events from the time of each study vaccination through 28 days after each study vaccination.
Within 28 days post each dose
Clinical safety laboratory parameters
Time Frame: Within 28 days post each dose
Occurrence of clinically significant changes in clinical safety laboratory parameters from the time of each vaccination through 28 days after each study vaccination.
Within 28 days post each dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Seroconversion rates of IgG antibody responses to OSP
Time Frame: Baseline and at 28 days post the first and second dose
Proportion of participants achieving seroconversion (defined as a 4-fold increase of serum anti-OSP IgG antibody titer at approximately 28 days after the first and second dose of investigational product compared to baseline
Baseline and at 28 days post the first and second dose
Geometric Mean Titers (GMTs) of serum anti-OSP IgG
Time Frame: Baseline and at 28 days post the first and second dose
GMTs of serum anti-OSP IgG antibodies at 28 days after the first and second dose of investigational product compared to baseline
Baseline and at 28 days post the first and second dose
Geometric Mean Fold Rise (GMFR) of serum anti-OSP IgG
Time Frame: At 28 days post the first and second dose
GMFR of serum anti-OSP IgG antibodies at 28 days after the first and second dose of investigational product
At 28 days post the first and second dose
Seroconversion rates of serum vibriocidal antibody titers
Time Frame: Baseline and at 28 days post the first and second dose
Proportion of participants with a 4-fold or greater rises in serum vibriocidal antibody titers against V. cholerae O1 Inaba and V. cholerae O1 Ogawa, relative to baseline, 28 days after the first and second dose of investigational product compared to baseline
Baseline and at 28 days post the first and second dose
GMT of serum vibriocidal antibody titers
Time Frame: Baseline and at 28 days post the first and second dose

Geometric Mean Titers (GMT) of serum vibriocidal antibody titers against V. cholerae O1 Inaba and V. cholerae O1 Ogawa at 28 days after the first and second dose of investigational product compared to baseline

.
Baseline and at 28 days post the first and second dose
GMFR of serum vibriocidal antibody titers
Time Frame: At 28 days post the first and second dose
GMFR of serum vibriocidal antibody titers against V. cholerae O1 Inaba and V. cholerae O1 Ogawa at 28 days after the first and second dose of investigational product
At 28 days post the first and second dose

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Seroconversion of serum anti-TT antibody titer
Time Frame: Baseline and at 28 days post the first and second dose
Proportion of participants achieving seroconversion (defined as at least 4-fold increase) of serum anti-TT antibody titer at 28 days after first and second dose vaccination compared to baseline
Baseline and at 28 days post the first and second dose
Memory B Cell responses
Time Frame: Baseline, 28 days, and 6 months
Memory B Cell responses measured by Elispot assay at 28 days after the first dose vaccination and 6 months after second dose vaccination compared to baseline.
Baseline, 28 days, and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
International Vaccine Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Massachusetts General Hospital
EuBiologics Co.,Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anh Wartel, MD, +82 2 8811 274

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 5, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 8, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 23, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IVI-CCV-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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