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

Last updated: March 21, 2025
Sponsor: International Vaccine Institute
Overall Status: Completed

Phase

1

Condition

N/A

Treatment

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

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

Placebo Cohort B

Clinical Study ID

NCT05559983
IVI-CCV-001
  • Ages 19-45
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Healthy Korean participants aged 19 to 45 years at consent

  2. Participants willing to provide written informed consent to participate studyvoluntarily

  3. Participants who can be followed up during the study period and can comply with thestudy requirements

  4. Individual in good health as determined by the outcome of medical history, physicalexamination, laboratory evaluations and the clinical judgment of the investigator

  5. Females of childbearing potential with negative pregnancy test result on the day ofscreening

  6. Females of childbearing potential who agree to use an effective birth controlmethod* 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 upto 12 weeks after the second dose vaccination

Exclusion

Exclusion Criteria:

  1. Known history or allergy to investigational vaccine components and/or excipients orother medications, or any other allergies deemed by the investigator to increase therisk of an adverse event if they were to participate in the trial

  2. Individuals with major congenital abnormalities which in the opinion of investigatormay 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 forperiods exceeding 2 consecutive weeks), or receive chemotherapy, radiation therapyor other immunosuppressive drugs within the past 6 months.

  5. Individuals with behavioral or cognitive impairment or psychiatric disease or neuraldisorders that, in the opinion of the investigator, could interfere with theparticipant's ability to participate in the trial

  6. Individuals with splenectomy

  7. Individuals with a known bleeding diathesis, or any condition that may be associatedwith a prolonged bleeding time resulting in contraindication for intramuscularinjections/blood extractions

  8. Receipt of blood, blood-derived products, or immunoglobulin products in the past 3months

  9. Individuals who have received other vaccines from 4 weeks prior to the first dose oftest vaccination or planned to receive any vaccine within 4 weeks of the last doseof 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 emergencyroom 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 thestudy 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 6months prior to enrollment, concomitantly enrolled or scheduled to be enrolled inanother trial

  18. Individuals who are research staff involved with the clinical study orfamily/household members of research staff

Study Design

Total Participants: 150
Treatment Group(s): 9
Primary Treatment: OSP:rTTHc Cholera Conjugate Vaccine with Aluminum phosphate adjuvant Cohort B
Phase: 1
Study Start date:
December 05, 2022
Estimated Completion Date:
January 23, 2024

Study 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.

Connect with a study center

  • CHA Bundang Medical Center (CBMC) of CHA University

    Seoul, 08826
    Korea, Republic of

    Site Not Available

  • Soon Chun Hyang University Hospital

    Seoul, 08826
    Korea, Republic of

    Site Not Available

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

    Seoul, 06591
    Korea, Republic of

    Site Not Available

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