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Cholera Vaccination ReactionPhase 1NCT05559983

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

A Phase 1 study testing OSP:rTTHc Cholera Conjugate Vaccine Cohort A, OSP:rTTHc Cholera Conjugate Vaccine with Aluminum phosphate adjuvant Cohort A and OSP:rTTHc Cholera Conjugate Vaccine Cohort B in people with Cholera Vaccination Reaction, run by International Vaccine Institute at 3 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 19 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Cholera Vaccination Reaction
What is being tested?
OSP:rTTHc Cholera Conjugate Vaccine Cohort A, OSP:rTTHc Cholera Conjugate Vaccine with Aluminum phosphate adjuvant Cohort A and OSP:rTTHc Cholera Conjugate Vaccine Cohort B
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
3 sitesSouth Korea
Study dates
5 Dec 2022to 23 Jan 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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
  • Individuals with major congenital abnormalities which in the opinion of investigator may affect the participant's participation in the study
  • Known history of immune function disorders including immunodeficiency diseases (known HIV infection or other immune function disorders)
  • 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.
  • 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
  • Individuals with splenectomy
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  • 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
  • Receipt of blood, blood-derived products, or immunoglobulin products in the past 3 months
  • 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
  • Body mass index (BMI) ≥ 35 kg/m2
  • Individuals with active or previous Vibrio cholerae infection
  • Individuals with history of severe diarrhea requiring hospitalization or emergency room visit for the last 5 years
  • Individuals with receipt of a cholera vaccine
  • Individuals who lived in cholera endemic areas for more than 6 months for the past 10 years
  • As per Investigator's medical judgement, an individual could be excluded from the study despite meeting all inclusion/exclusion criteria mentioned above
  • Any female participant who is lactating*, pregnant or planning for pregnancy** during study period
  • 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
  • Individuals who are research staff involved with the clinical study or family/household members of research staff

Trial locations and contacts

3 sites in 1 country.

South Korea3 sites

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

    Seoul, 06591

  • CHA Bundang Medical Center (CBMC) of CHA University

    Seoul, 08826

  • Soon Chun Hyang University Hospital

    Seoul, 08826

Other trials in South Korea

About this study

Official title: 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.

Read the 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.
Being tested
OSP:rTTHc Cholera Conjugate Vaccine Cohort A, OSP:rTTHc Cholera Conjugate Vaccine with Aluminum phosphate adjuvant Cohort A, Placebo Cohort A, OSP:rTTHc Cholera Conjugate Vaccine Cohort B, OSP:rTTHc Cholera Conjugate Vaccine with Aluminum phosphate adjuvant Cohort B
Keywords
Cholera Conjugate Vaccine, O Specific Polysaccharide, Recombinant Tetanus Toxoid Heavy Chain Fragment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OSP:rTTHc Cholera Conjugate Vaccine Cohort ABiological

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

  • OSP:rTTHc Cholera Conjugate Vaccine with Aluminum phosphate adjuvant Cohort ABiological

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

  • Placebo Cohort AOther

    Sterile 0.9% sodium chloride

  • OSP:rTTHc Cholera Conjugate Vaccine Cohort BBiological

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

  • OSP:rTTHc Cholera Conjugate Vaccine with Aluminum phosphate adjuvant Cohort BBiological

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

  • Placebo Cohort BOther

    Sterile 0.9% sodium chloride

  • OSP:rTTHc Cholera Conjugate Vaccine Cohort CBiological

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

  • OSP:rTTHc Cholera Conjugate Vaccine with Aluminum phosphate adjuvant Cohort CBiological

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

  • Placebo Cohort COther

    Sterile 0.9% sodium chloride

Study groups in NCT05559983
Study groupRoleWhat they receive
OSP:rTTHc Cholera Conjugate VaccineExperimental2 doses @0.5 mL of test vaccine administered intramuscularly in deltoid region at 4 weeks apart
Receives: Biological: OSP:rTTHc Cholera Conjugate Vaccine Cohort A; Biological: OSP:rTTHc Cholera Conjugate Vaccine Cohort B; Biological: OSP:rTTHc Cholera Conjugate Vaccine Cohort C
OSP:rTTHc Cholera Conjugate Vaccine with Aluminum phosphate adjuvantExperimental2 doses @0.5 mL of test vaccine administered intramuscularly in deltoid region at 4 weeks apart
Receives: Biological: OSP:rTTHc Cholera Conjugate Vaccine with Aluminum phosphate adjuvant Cohort A; Biological: OSP:rTTHc Cholera Conjugate Vaccine with Aluminum phosphate adjuvant Cohort B; Biological: OSP:rTTHc Cholera Conjugate Vaccine with Aluminum phosphate adjuvant Cohort C
PlaceboPlacebo comparator2 doses @0.5 mL of Sterile 0.9% sodium chloride administered intramuscularly in deltoid region at 4 weeks apart
Receives: Other: Placebo Cohort A; Other: Placebo Cohort B; Other: Placebo Cohort C

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serious adverse events (SAEs) and adverse events of special interest (AESIs)

    Occurrence of any SAEs/AESIs from the time of the first dose of study vaccine

    Measured: Entire study participation period (approximately 7 months)

  2. Immediate adverse events

    Occurrence of immediate adverse events within 30 minutes from the time of each study vaccination.

    Measured: Within 30 minutes post each dose

  3. Solicited adverse events

    Occurrence of solicited injection site and solicited systemic adverse events from the time of each study vaccination through 7 days after each study vaccination

    Measured: Within 7 days post each dose

  4. Unsolicited adverse events

    Occurrence of unsolicited adverse events from the time of each study vaccination through 28 days after each study vaccination.

    Measured: Within 28 days post each dose

  5. Clinical safety laboratory parameters

    Occurrence of clinically significant changes in clinical safety laboratory parameters from the time of each vaccination through 28 days after each study vaccination.

    Measured: Within 28 days post each dose

Secondary outcomes (6)

  1. Seroconversion rates of IgG antibody responses to OSP

    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

    Measured: Baseline and at 28 days post the first and second dose

  2. Geometric Mean Titers (GMTs) of serum anti-OSP IgG

    GMTs of serum anti-OSP IgG antibodies at 28 days after the first and second dose of investigational product compared to baseline

    Measured: Baseline and at 28 days post the first and second dose

  3. Geometric Mean Fold Rise (GMFR) of serum anti-OSP IgG

    GMFR of serum anti-OSP IgG antibodies at 28 days after the first and second dose of investigational product

    Measured: At 28 days post the first and second dose

  4. Seroconversion rates of serum vibriocidal antibody titers

    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

    Measured: Baseline and at 28 days post the first and second dose

  5. GMT of serum vibriocidal antibody titers

    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

    .

    Measured: Baseline and at 28 days post the first and second dose

  6. GMFR of serum vibriocidal antibody titers

    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

    Measured: At 28 days post the first and second dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2022
  2. Study start5 Dec 2022
  3. Primary completion8 Sep 2023
  4. Study completion23 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
The first fifty participant in the study will be enrolled into cohort A and receive low antigen product with or without adjuvant, or placebo. The Safety Monitoring Committee (SMC) and the independent Data Safety Monitoring Board (DSMB) will review the safety data collected through seven days after the second dose vaccination of the cohort A before the study enrollment can progress to cohort B (middle dose). Dose escalation to cohort C (high dose) will follow the same procedures.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05559983
Sponsor's protocol ID
IVI-CCV-001
Status last verified
Mar 2025
First submitted
21 Sep 2022
Last updated
25 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kelly M, Janardhanan J, Wagh C, Verma S, Charles RC, Leung DT, Kamruzzaman M, Pansuriya RK, Chowdhury F, Vann WF, Kaminski RW, Khan AI, Bhuiyan TR, Qadri F, Kovac P, Xu P, Ryan ET. Development of a Shigella conjugate vaccine targeting Shigella flexneri 6 that is immunogenic and provides protection against virulent challenge. Vaccine. 2024 Oct 24;42(24):126263. doi: 10.1016/j.vaccine.2024.126263. Epub 2024 Aug 31.

    PubMed 39217775

  • Kelly M, Jeon S, Yun J, Lee B, Park M, Whang Y, Lee C, Charles RC, Bhuiyan TR, Qadri F, Kamruzzaman M, Cho S, Vann WF, Xu P, Kovac P, Ganapathy R, Lynch J, Ryan ET. Vaccination of Rabbits with a Cholera Conjugate Vaccine Comprising O-Specific Polysaccharide and a Recombinant Fragment of Tetanus Toxin Heavy Chain Induces Protective Immune Responses against Vibrio cholerae O1. Am J Trop Med Hyg. 2023 Oct 2;109(5):1122-1128. doi: 10.4269/ajtmh.23-0259. Print 2023 Nov 1.

    PubMed 37783453

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing OSP:rTTHc Cholera Conjugate Vaccine Cohort A, OSP:rTTHc Cholera Conjugate Vaccine with Aluminum phosphate adjuvant Cohort A and OSP:rTTHc Cholera Conjugate Vaccine Cohort B in people with Cholera Vaccination Reaction, run by International Vaccine Institute at 3 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serious adverse events (SAEs) and adverse events of special interest (AESIs) (time frame: Entire study participation period (approximately 7 months)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05559983, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.

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