Cholera VaccinationPhase 2NCT07509047
Age-descending Study to Evaluate the Safety and Immunogenicity of the Cholera Conjugate Vaccine in Adults and Children
A Phase 2 study testing OSP:rTTHc CCV 25 ㎍ with Aluminum phosphate, OSP:rTTHc CCV 25 ㎍ without Aluminum phosphate and Euvichol®-Plus in people with Cholera Vaccination, run by International Vaccine Institute at 1 site in Kenya.
Trial summary
This phase II study is intended to determine the immunogenicity and safety of single dose and two doses of OSP:rTTHc cholera conjugate vaccine (CCV) with or without alum adjuvant. Read more about this study
- Who is it for?
- Ages 1 year to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cholera Vaccination
- What is being tested?
- OSP:rTTHc CCV 25 ㎍ with Aluminum phosphate, OSP:rTTHc CCV 25 ㎍ without Aluminum phosphate and Euvichol®-Plus
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 390 participants
- Where
- 1 siteKenya
- Study dates
- 13 Jan 2026to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 1 year to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Individuals aged 1 to 45 years at consent
- Participants/ Participants' legally authorized representative (LAR) willing to provide written informed consent to participate in the study voluntarily
- Participants who can comply with the study requirements
- Individuals in good health as determined by the outcome of medical history, physical examination, and the clinical judgment of the investigator
Who cannot join
- Known history or allergy to investigational vaccine components or other medications, or any other allergies
- Individuals with major congenital abnormalities
- 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.
- Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the participant and interfere with the assessment of the study objectives
- 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
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- Individuals with splenectomy
- Individuals with known bleeding disorders
- 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.
- Individuals with active or known previous Vibrio cholerae infection
- Individuals with a history of severe diarrhea in the last 6 months requiring care at a medical facility lasting 24 hours or more
- Individuals with prior receipt of a cholera vaccine in the last 5 years
- Any female participant who is lactating or pregnant
- Females of childbearing potential who do not agree to use an effective birth control method for at least 4 weeks before the screening and up to 12 weeks after the study vaccination.
- Individuals enrolled in another clinical trial within 6 months prior to enrollment, concomitantly enrolled or scheduled to be enrolled in another trial during study period
- Individuals who are research staff involved with the clinical trial or family/household members of research staff
- As per Investigator's medical judgement, an individual could also be excluded from the study despite meeting all inclusion/exclusion criteria mentioned above
- Children below 5 years old with Weight for Height Z score and/or Height for Age Z score of less than -2
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kenya1 site, 1 recruiting
- Recruiting
KAVI-Institute of Clinical Research, University
Nairobi, Kenyatta National Hospital Complex, 19676
Jaoko Walter Godfrey, +254-727-555-254, wjaoko@kaviuon.org
About this study
Official title: A Phase II, Randomized, Controlled, Age-descending Study in Adults and Children to Evaluate the Safety and Immunogenicity of the OSP:rTTHc Cholera Conjugate Vaccine in Cholera-endemic Region
This phase II study is intended to determine the immunogenicity and safety of single dose and two doses of OSP:rTTHc cholera conjugate vaccine (CCV) with or without alum adjuvant. The study will guide the future dosing schedule and formulation of CCV (with or without Aluminum phosphate adjuvant) expected to be needed in adults and children in cholera-endemic region.
Read the detailed description
This is phase II, randomized, controlled, safety and immunogenicity study of one and two doses of the of CCV 25 μg (with and without alum) in cholera-endemic region.
A total of 390 eligible participants will be recruited in the study into 3 age cohorts.
This will be a randomized, placebo-controlled, observer blind study in adults aged 18 to 45 years (cohort A) and children aged 5 to 17 years (cohort B) followed by a randomized, active-controlled, partial open label study in children aged 1 to 4 years (cohort C).
The DSMB must review the safety data of each cohort and approve study continuation before investigational product administration of the next younger cohort is initiated (age descending study scheme).
In cohort A, 50 adult participants aged 18 to 45 years will be randomly divided into 5 arms to receive the assigned investigational product as follows:
Arm A1 (n=10): one dose of CCV 25 μg with alum and one dose of placebo at 6 months interval Arm A2 (n=10): one dose of CCV 25 μg without alum and one dose of placebo at 6 months interval Arm A3 (n=10): two doses of CCV 25 μg with alum at 6 months interval Arm A4 (n=10): two doses of CCV 25 μg without alum at 6 months interval Arm A5 (n=10): two doses of placebo at 6 months interval
In cohort B, 90 children aged 5 to 17 years will be randomly divided into 5 arms to receive the assigned investigational product as follows:
Arm B1 (n=20): one dose of CCV 25 μg with alum and one dose of placebo at 6 months interval Arm B2 (n=20): one dose of CCV 25 μg without alum and one dose of placebo at 6 months interval Arm B3 (n=20): two doses of CCV 25 μg with alum at 6 months interval Arm B4 (n=20): two doses of CCV 25 μg without alum at 6 months interval Arm B5 (n=10): two doses of placebo at 6 months interval
In cohort C, 250 children aged 1 to 4 years will be randomly divided into 10 arms to receive the assigned investigational product as follows:
Arm C1 (n=30): one dose of CCV 25 μg with alum and one dose of placebo at 6 months interval Arm C2 (n=30): one dose of CCV 25 μg without alum and one dose of placebo at 6 months interval Arm C3 (n=30): two doses of CCV 25 μg with alum at 6 months interval Arm C4 (n=30): two doses of CCV 25 μg without alum at 6 months interval Arm C5 (n=20): two doses of placebo at 6 months interval Arm C6 (n=30): two doses of Euvichol®-Plus at 2 weeks interval Arm C7 (n=20): one dose of CCV 25 μg with alum and one dose of Euvichol®-Plus at 6 months interval Arm C8 (n=20): one dose of CCV 25 μg without alum and one dose of Euvichol®-Plus at 6 months interval Arm C9 (n=20): one dose of Euvichol®-Plus and one dose of CCV 25 μg with alum at 6 months interval Arm C10 (n=20): one dose of Euvichol®-Plus and one dose of CCV 25 μg without alum at 6 months interval
Route of vaccination: CCV 25 μg (with or without alum) and placebo are administered by intramuscular (IM) injection. Euvichol®-Plus is administered orally.
- Conditions
- Cholera Vaccination
- Being tested
- OSP:rTTHc CCV 25 ㎍ with Aluminum phosphate, OSP:rTTHc CCV 25 ㎍ without Aluminum phosphate, Euvichol®-Plus, Placebo, CCV with Aluminum, Euvichol®-Plus
- Keywords
- Cholera Conjugate Vaccine, O Specific Polysaccharide, Recombinant Tetanus Toxoid Heavy Chain Fragment, Cholera Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSP:rTTHc CCV 25 ㎍ with Aluminum phosphateBiological
OSP:rTTHc Cholera Conjugate with Aluminum phosphate Cohort Arms A1, A3, B1, B3, C1, C3, C10
OSP:rTTHc CCV 25 ㎍ without Aluminum phosphateBiological
OSP:rTTHc Cholera Conjugate without Aluminum phosphate Cohort Arms A2, A4, B2, B4, C2, C4
Euvichol®-PlusBiological
- cholerae O1 and O139 bivalent inactivated oral cholera vaccine cohort Arm C6
PlaceboOther
Sterile 0.9% sodium chloride cohort Arms A5, B5, C5
CCV with Aluminum, Euvichol®-PlusBiological
- OSP:rTTHc CCV 25 # with Aluminum phosphate OSP:rTTHc Cholera Conjugate with Aluminum phosphate
- Euvichol®-Plus V. cholerae O1 and O139 bivalent inactivated oral cholera vaccine
Cohort Arms C7, C9
CCV without Aluminum, Euvichol®-PlusBiological
- OSP:rTTHc CCV 25 # without Aluminum phosphate OSP:rTTHc Cholera Conjugate without Aluminum phosphate
- Euvichol®-Plus V. cholerae O1 and O139 bivalent inactivated oral cholera vaccine
Cohort Arms C8, C10
| Study group | Role | What they receive |
|---|---|---|
| OSP:rTTHc CCV 25 ㎍ with Aluminum phosphate | Experimental | 0.5 mL per dose; dosing schedule/duration: 1 dose or 2 doses at 168-days interval administered intramuscularly Receives: Biological: OSP:rTTHc CCV 25 ㎍ with Aluminum phosphate |
| OSP:rTTHc CCV 25 ㎍ without Aluminum phosphate | Experimental | 0.5 mL per dose; dosing schedule/duration: 1 dose or 2 doses at 168-days interval administered intramuscularly Receives: Biological: OSP:rTTHc CCV 25 ㎍ without Aluminum phosphate |
| Euvichol®-Plus | Active comparator | 1.5 mL per dose; dosing schedule/duration: 2 doses at 14-days interval administered orally Receives: Biological: Euvichol®-Plus |
| Isotonic Sodium Chloride injection | Placebo comparator | 0.5 mL per dose; dosing schedule/duration: 2 doses at 168-days interval administered intramuscularly Receives: Other: Placebo |
| OSP:rTTHc CCV 25 ㎍ with Aluminum phosphate and Euvichol®-Plus | Experimental | 0.5 mL per dose of CCV administered intramuscularly and 1.5 mL dose of Euvichol®-Plus administered orally at 168-days interval Receives: Biological: CCV with Aluminum, Euvichol®-Plus |
| OSP:rTTHc CCV 25 ㎍ without Aluminum phosphate and Euvichol®-Plus | Experimental | 0.5 mL per dose of CCV administered intramuscularly and 1.5 mL dose of Euvichol®-Plus administered orally at 168-days interval Receives: Biological: CCV without Aluminum, Euvichol®-Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion of Serum vibriocidal antibody titers responses to V. cholerae O1 Inaba and O1 Ogawa at 28 days after one dose vaccination of CCV 25 μg (with or without alum) in adults (aged 18 to 45 years) and in children (aged 1 to 17 years).
- Proportion of participants achieving seroconversion (defined as at least 4-fold increase from baseline) of serum vibriocidal antibody titers at 28 days after one dose vaccination of CCV (with or without alum) 25 μg / placebo
Measured: Baseline and at 28 days post the first dose of either CCV with alum, CCV without alum or placebo
GMT of Serum vibriocidal antibody titers to V. cholerae O1 Inaba and O1 Ogawa after one dose of CCV 25 μg (with or without alum) in adults (aged 18 to 45 years) and in children (aged 1 to 17 years)
- GMT of serum vibriocidal antibody titers at 28 days after one dose vaccination of CCV (with or without alum) 25 μg / placebo
Measured: Baseline and at 28 days post the first dose of either CCV with alum, CCV without alum or placebo
Seroconversion of vibriocidal titers against V. cholerae O1 Inaba and O1 Ogawa after two doses of Euvichol®-Plus in children aged 1 to 4 years
Proportion of participants achieving seroconversion of serum vibriocidal antibody titers at 14 days after two doses of Euvichol®-Plus
Measured: Baseline and at 14 days post two doses of Euvichol®-Plus
GMT of vibriocidal titers against V. cholerae O1 Inaba and O1 Ogawa after two doses of Euvichol®-Plus in children aged 1 to 4 years
GMT of serum vibriocidal antibody titers at 14 days after two doses of Euvichol®-Plus compared to baseline
Measured: Baseline and at 14 days after two doses of Euvichol®-Plus
Seroconversion of Serum OSP IgG antibody titers against V. cholerae O1 Inaba after one dose vaccination of CCV 25 μg (with or without alum) in adults (aged 18 to 45 years) and in children (aged 1 to 17 years).
Proportion of participants achieving seroconversion (defined as at least 4-fold increase from baseline) of serum OSP IgG antibody titers at 28 days after one dose vaccination of CCV (with or without alum) 25 μg / placebo
Measured: Baseline and at 28 days post the first dose of either CCV with alum, CCV without alum or placebo
GMT of Serum OSP IgG antibody titers to V. cholerae O1 Inaba and O1 Ogawa after one dose of CCV 25 μg (with or without alum) in adults (aged 18 to 45 years) and in children (aged 1 to 17 years)
- GMT of serum OSP IgG antibody titers at 28 days after one dose vaccination of CCV (with or without alum) 25 μg / placebo
Measured: Baseline and at 28 days post the first dose of either CCV with alum, CCV without alum or placebo
Seroconversion of OSP IgG titers against V. cholerae O1 Inaba and O1 Ogawa after two doses of Euvichol®-Plus in children aged 1 to 4 years
Proportion of participants achieving seroconversion of serum OSP IgG antibody titers at 14 days after two doses of Euvichol®-Plus
Measured: Baseline and at 14 days post two doses of Euvichol®-Plus
GMT of OSP IgG titers against V. cholerae O1 Inaba and O1 Ogawa after two doses of Euvichol®-Plus in children aged 1 to 4 years:
GMT of serum OSP IgG antibody titers at 14 days after two doses of Euvichol®-Plus compared to baseline
Measured: Baseline and at 14 days after two doses of Euvichol®-Plus
Secondary outcomes (12)
Serious adverse events (SAEs) and adverse events of special interest (AESIs) and medically attended adverse event (MAAE)
Occurrence of any SAE / AESI / MAAE from the first dose vaccination throughout the final study visit
Measured: through study completion, an average of 6 months
Immediate adverse events
Occurrence of immediate adverse events within 30 minutes after each dose vaccination
Measured: Within 30 minutes post each dose
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
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
Seroconversion of Serum vibriocidal antibody titers responses to V. cholerae O1 Inaba and O1 Ogawa at 28 days after two doses of CCV 25 μg (with or without alum) / placebo in adults (aged 18 to 45 years) and in children (aged 1 to 17 years.
- Proportion of participants achieving seroconversion of serum vibriocidal antibody titers at 28 days after two doses of CCV 25 μg (with or without alum) / placebo
Measured: Baseline and at 28 days post the second dose of either CCV with alum, CCV without alum or placebo
Seroconversion of IgG antibody responses to OSP against V. cholerae O1 Inaba at 28 days after two doses of CCV 25 μg (with or without alum).or placebo in adults (aged 18 to 45 years) and in children (aged 1 to 17 years.
- Proportion of participants achieving seroconversion of serum anti-OSP IgG antibody titer at 28 days after two doses of CCV (with or without alum) 25 μg or placebo
Measured: Baseline and at 28 days post the second dose of either CCV with alum, CCV without alum or placebo]
Seroconversion of Serum vibriocidal antibody titers against V. cholerae O1 Inaba and O1 Ogawa at 28 days after booster dose in heterologous boosting group of CCV with or without alum 25 μg and Euvichol®-Plus in children aged 1 to 4 years
- Proportion of participants achieving seroconversion of serum vibriocidal antibody titers after the heterologous booster dose
Measured: Baseline and at 28 days post the heterologous booster dose
Seroconversion of IgG antibody responses to OSP against V. cholerae O1 Inaba at 28 days after booster dose in heterologous boosting group of CCV with or without alum 25 μg and Euvichol®-Plus in children aged 1 to 4 years
- Proportion of participants achieving seroconversion of serum vibriocidal antibody titers after the heterologous booster dose
Measured: Baseline and at 28 days post the heterologous booster dose
GMT of Serum vibriocidal antibody titers responses to V. cholerae O1 Inaba and O1 Ogawa at 28 days after two doses of CCV 25 μg (with or without alum) / placebo in adults (aged 18 to 45 years) and in children (aged 1 to 17 years.
GMT of serum vibriocidal antibody titers at 28 days after two doses of CCV 25 μg (with or without alum) / placebo
Measured: Baseline and at 28 days post the second dose of either CCV with alum, CCV without alum or placebo
GMT of IgG antibody responses to OSP against V. cholerae O1 Inaba at 28 days after two doses of CCV 25 μg (with or without alum).or placebo in adults (aged 18 to 45 years) and in children (aged 1 to 17 years.
GMT of serum anti-OSP IgG antibody titer at 28 days after two doses of CCV (with or without alum) 25 μg or placebo
Measured: Baseline and at 28 days post the second dose of either CCV with alum, CCV without alum or placebo]
GMT of Serum vibriocidal antibody titers against V. cholerae O1 Inaba and O1 Ogawa at 28 days after booster dose in heterologous boosting group of CCV with or without alum 25 μg and Euvichol®-Plus in children aged 1 to 4 years
GMT of serum vibriocidal antibody titers after the heterologous booster dose
Measured: Baseline and at 28 days post the heterologous booster dose
GMT of IgG antibody responses to OSP against V. cholerae O1 Inaba at 28 days after booster dose in heterologous boosting group of CCV with or without alum 25 μg and Euvichol®-Plus in children aged 1 to 4 years
GMT of serum vibriocidal antibody titers after the heterologous booster dose
Measured: Baseline and at 28 days post the heterologous booster dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start13 Jan 2026
- Primary completionMar 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholera VaccinationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is phase II, randomized, controlled, safety and immunogenicity study of one and two doses of the of CCV 25 μg (with and without alum) in cholera-endemic region. A total of 390 eligible participants will be recruited in the study into 3 age cohorts
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Vaccine Institute
- Sponsor type
- University, hospital or other
- Collaborators
- EuBiologics Co.,Ltd, Massachusetts General Hospital
- Responsible party
- Sponsor
- Investigators
- Julia Lynch, MD, Principal investigator, International Vaccine Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509047
- Sponsor's protocol ID
- IVI CCV 002
- Status last verified
- Mar 2026
- First submitted
- 31 Dec 2025
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Controlled, Age-descending Study in Adults and Children to Evaluate the Safety and Immunogenicity of the OSP:rTTHc Cholera Conjugate Vaccine in Cholera-endemic Region
- ClinicalTrials.gov ID
- NCT07509047
- Acronym / sponsor ID
- IVI CCV 002
- Conditions
- Cholera Vaccination
- Keywords
- Cholera Conjugate Vaccine, O Specific Polysaccharide, Recombinant Tetanus Toxoid Heavy Chain Fragment, Cholera Vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- International Vaccine InstituteUniversity, hospital or other
- Collaborators
- EuBiologics Co.,Ltd, Massachusetts General Hospital
- Study start
- 13 Jan 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II study is intended to determine the immunogenicity and safety of single dose and two doses of OSP:rTTHc cholera conjugate vaccine (CCV) with or without alum adjuvant. The study will guide the future dosing schedule and formulation of CCV (with or without Aluminum phosphate adjuvant) expected to be needed in adults and children in cholera-endemic region.
Detailed description
This is phase II, randomized, controlled, safety and immunogenicity study of one and two doses of the of CCV 25 μg (with and without alum) in cholera-endemic region.
A total of 390 eligible participants will be recruited in the study into 3 age cohorts.
This will be a randomized, placebo-controlled, observer blind study in adults aged 18 to 45 years (cohort A) and children aged 5 to 17 years (cohort B) followed by a randomized, active-controlled, partial open label study in children aged 1 to 4 years (cohort C).
The DSMB must review the safety data of each cohort and approve study continuation before investigational product administration of the next younger cohort is initiated (age descending study scheme).
In cohort A, 50 adult participants aged 18 to 45 years will be randomly divided into 5 arms to receive the assigned investigational product as follows:
Arm A1 (n=10): one dose of CCV 25 μg with alum and one dose of placebo at 6 months interval Arm A2 (n=10): one dose of CCV 25 μg without alum and one dose of placebo at 6 months interval Arm A3 (n=10): two doses of CCV 25 μg with alum at 6 months interval Arm A4 (n=10): two doses of CCV 25 μg without alum at 6 months interval Arm A5 (n=10): two doses of placebo at 6 months interval
In cohort B, 90 children aged 5 to 17 years will be randomly divided into 5 arms to receive the assigned investigational product as follows:
Arm B1 (n=20): one dose of CCV 25 μg with alum and one dose of placebo at 6 months interval Arm B2 (n=20): one dose of CCV 25 μg without alum and one dose of placebo at 6 months interval Arm B3 (n=20): two doses of CCV 25 μg with alum at 6 months interval Arm B4 (n=20): two doses of CCV 25 μg without alum at 6 months interval Arm B5 (n=10): two doses of placebo at 6 months interval
In cohort C, 250 children aged 1 to 4 years will be randomly divided into 10 arms to receive the assigned investigational product as follows:
Arm C1 (n=30): one dose of CCV 25 μg with alum and one dose of placebo at 6 months interval Arm C2 (n=30): one dose of CCV 25 μg without alum and one dose of placebo at 6 months interval Arm C3 (n=30): two doses of CCV 25 μg with alum at 6 months interval Arm C4 (n=30): two doses of CCV 25 μg without alum at 6 months interval Arm C5 (n=20): two doses of placebo at 6 months interval Arm C6 (n=30): two doses of Euvichol®-Plus at 2 weeks interval Arm C7 (n=20): one dose of CCV 25 μg with alum and one dose of Euvichol®-Plus at 6 months interval Arm C8 (n=20): one dose of CCV 25 μg without alum and one dose of Euvichol®-Plus at 6 months interval Arm C9 (n=20): one dose of Euvichol®-Plus and one dose of CCV 25 μg with alum at 6 months interval Arm C10 (n=20): one dose of Euvichol®-Plus and one dose of CCV 25 μg without alum at 6 months interval
Route of vaccination: CCV 25 μg (with or without alum) and placebo are administered by intramuscular (IM) injection. Euvichol®-Plus is administered orally.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- This is phase II, randomized, controlled, safety and immunogenicity study of one and two doses of the of CCV 25 μg (with and without alum) in cholera-endemic region. A total of 390 eligible participants will be recruited in the study into 3 age cohorts
| Arm | Type | Receives |
|---|---|---|
| OSP:rTTHc CCV 25 ㎍ with Aluminum phosphate | Experimental | Biological: OSP:rTTHc CCV 25 ㎍ with Aluminum phosphate0.5 mL per dose; dosing schedule/duration: 1 dose or 2 doses at 168-days interval administered intramuscularly |
| OSP:rTTHc CCV 25 ㎍ without Aluminum phosphate | Experimental | Biological: OSP:rTTHc CCV 25 ㎍ without Aluminum phosphate0.5 mL per dose; dosing schedule/duration: 1 dose or 2 doses at 168-days interval administered intramuscularly |
| Euvichol®-Plus | Active comparator | Biological: Euvichol®-Plus1.5 mL per dose; dosing schedule/duration: 2 doses at 14-days interval administered orally |
| Isotonic Sodium Chloride injection | Placebo comparator | Other: Placebo0.5 mL per dose; dosing schedule/duration: 2 doses at 168-days interval administered intramuscularly |
| OSP:rTTHc CCV 25 ㎍ with Aluminum phosphate and Euvichol®-Plus | Experimental | Biological: CCV with Aluminum, Euvichol®-Plus0.5 mL per dose of CCV administered intramuscularly and 1.5 mL dose of Euvichol®-Plus administered orally at 168-days interval |
| OSP:rTTHc CCV 25 ㎍ without Aluminum phosphate and Euvichol®-Plus | Experimental | Biological: CCV without Aluminum, Euvichol®-Plus0.5 mL per dose of CCV administered intramuscularly and 1.5 mL dose of Euvichol®-Plus administered orally at 168-days interval |
Who may qualify
- Ages
- 1 year to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Individuals aged 1 to 45 years at consent
- Participants/ Participants' legally authorized representative (LAR) willing to provide written informed consent to participate in the study voluntarily
- Participants who can comply with the study requirements
- Individuals in good health as determined by the outcome of medical history, physical examination, and the clinical judgment of the investigator
Key exclusion criteria (19 listed)
- Known history or allergy to investigational vaccine components or other medications, or any other allergies
- Individuals with major congenital abnormalities
- 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.
- Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the participant and interfere with the assessment of the study objectives
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OSP:rTTHc CCV 25 ㎍ with Aluminum phosphateOSP:rTTHc Cholera Conjugate with Aluminum phosphate Cohort Arms A1, A3, B1, B3, C1, C3, C10 | Biological | OSP:rTTHc CCV 25 ㎍ with Aluminum phosphate |
| OSP:rTTHc CCV 25 ㎍ without Aluminum phosphateOSP:rTTHc Cholera Conjugate without Aluminum phosphate Cohort Arms A2, A4, B2, B4, C2, C4 | Biological | OSP:rTTHc CCV 25 ㎍ without Aluminum phosphate |
| Euvichol®-PlusV. cholerae O1 and O139 bivalent inactivated oral cholera vaccine cohort Arm C6 | Biological | Euvichol®-Plus |
| PlaceboSterile 0.9% sodium chloride cohort Arms A5, B5, C5 | Other | Isotonic Sodium Chloride injection |
| CCV with Aluminum, Euvichol®-Plus1. OSP:rTTHc CCV 25 # with Aluminum phosphate OSP:rTTHc Cholera Conjugate with Aluminum phosphate 2. Euvichol®-Plus V. cholerae O1 and O139 bivalent inactivated oral cholera vaccine Cohort Arms C7, C9 | Biological | OSP:rTTHc CCV 25 ㎍ with Aluminum phosphate and Euvichol®-Plus |
| CCV without Aluminum, Euvichol®-Plus1. OSP:rTTHc CCV 25 # without Aluminum phosphate OSP:rTTHc Cholera Conjugate without Aluminum phosphate 2. Euvichol®-Plus V. cholerae O1 and O139 bivalent inactivated oral cholera vaccine Cohort Arms C8, C10 | Biological | OSP:rTTHc CCV 25 ㎍ without Aluminum phosphate and Euvichol®-Plus |
Primary outcome
Seroconversion of Serum vibriocidal antibody titers responses to V. cholerae O1 Inaba and O1 Ogawa at 28 days after one dose vaccination of CCV 25 μg (with or without alum) in adults (aged 18 to 45 years) and in children (aged 1 to 17 years).
Time frame: Baseline and at 28 days post the first dose of either CCV with alum, CCV without alum or placebo
- Proportion of participants achieving seroconversion (defined as at least 4-fold increase from baseline) of serum vibriocidal antibody titers at 28 days after one dose vaccination of CCV (with or without alum) 25 μg / placebo
GMT of Serum vibriocidal antibody titers to V. cholerae O1 Inaba and O1 Ogawa after one dose of CCV 25 μg (with or without alum) in adults (aged 18 to 45 years) and in children (aged 1 to 17 years)
Time frame: Baseline and at 28 days post the first dose of either CCV with alum, CCV without alum or placebo
- GMT of serum vibriocidal antibody titers at 28 days after one dose vaccination of CCV (with or without alum) 25 μg / placebo
Seroconversion of vibriocidal titers against V. cholerae O1 Inaba and O1 Ogawa after two doses of Euvichol®-Plus in children aged 1 to 4 years
Time frame: Baseline and at 14 days post two doses of Euvichol®-Plus
Proportion of participants achieving seroconversion of serum vibriocidal antibody titers at 14 days after two doses of Euvichol®-Plus
GMT of vibriocidal titers against V. cholerae O1 Inaba and O1 Ogawa after two doses of Euvichol®-Plus in children aged 1 to 4 years
Time frame: Baseline and at 14 days after two doses of Euvichol®-Plus
GMT of serum vibriocidal antibody titers at 14 days after two doses of Euvichol®-Plus compared to baseline
Seroconversion of Serum OSP IgG antibody titers against V. cholerae O1 Inaba after one dose vaccination of CCV 25 μg (with or without alum) in adults (aged 18 to 45 years) and in children (aged 1 to 17 years).
Time frame: Baseline and at 28 days post the first dose of either CCV with alum, CCV without alum or placebo
Proportion of participants achieving seroconversion (defined as at least 4-fold increase from baseline) of serum OSP IgG antibody titers at 28 days after one dose vaccination of CCV (with or without alum) 25 μg / placebo
GMT of Serum OSP IgG antibody titers to V. cholerae O1 Inaba and O1 Ogawa after one dose of CCV 25 μg (with or without alum) in adults (aged 18 to 45 years) and in children (aged 1 to 17 years)
Time frame: Baseline and at 28 days post the first dose of either CCV with alum, CCV without alum or placebo
- GMT of serum OSP IgG antibody titers at 28 days after one dose vaccination of CCV (with or without alum) 25 μg / placebo
Seroconversion of OSP IgG titers against V. cholerae O1 Inaba and O1 Ogawa after two doses of Euvichol®-Plus in children aged 1 to 4 years
Time frame: Baseline and at 14 days post two doses of Euvichol®-Plus
Proportion of participants achieving seroconversion of serum OSP IgG antibody titers at 14 days after two doses of Euvichol®-Plus
GMT of OSP IgG titers against V. cholerae O1 Inaba and O1 Ogawa after two doses of Euvichol®-Plus in children aged 1 to 4 years:
Time frame: Baseline and at 14 days after two doses of Euvichol®-Plus
GMT of serum OSP IgG antibody titers at 14 days after two doses of Euvichol®-Plus compared to baseline
12 secondary outcomes
Serious adverse events (SAEs) and adverse events of special interest (AESIs) and medically attended adverse event (MAAE)
Time frame: through study completion, an average of 6 months
Immediate adverse events
Time frame: Within 30 minutes post each dose
Solicited adverse events
Time frame: Within 7 days post each dose
Unsolicited adverse events
Time frame: Within 28 days post each dose
Seroconversion of Serum vibriocidal antibody titers responses to V. cholerae O1 Inaba and O1 Ogawa at 28 days after two doses of CCV 25 μg (with or without alum) / placebo in adults (aged 18 to 45 years) and in children (aged 1 to 17 years.
Time frame: Baseline and at 28 days post the second dose of either CCV with alum, CCV without alum or placebo
Seroconversion of IgG antibody responses to OSP against V. cholerae O1 Inaba at 28 days after two doses of CCV 25 μg (with or without alum).or placebo in adults (aged 18 to 45 years) and in children (aged 1 to 17 years.
Time frame: Baseline and at 28 days post the second dose of either CCV with alum, CCV without alum or placebo]
Seroconversion of Serum vibriocidal antibody titers against V. cholerae O1 Inaba and O1 Ogawa at 28 days after booster dose in heterologous boosting group of CCV with or without alum 25 μg and Euvichol®-Plus in children aged 1 to 4 years
Time frame: Baseline and at 28 days post the heterologous booster dose
Seroconversion of IgG antibody responses to OSP against V. cholerae O1 Inaba at 28 days after booster dose in heterologous boosting group of CCV with or without alum 25 μg and Euvichol®-Plus in children aged 1 to 4 years
Time frame: Baseline and at 28 days post the heterologous booster dose
GMT of Serum vibriocidal antibody titers responses to V. cholerae O1 Inaba and O1 Ogawa at 28 days after two doses of CCV 25 μg (with or without alum) / placebo in adults (aged 18 to 45 years) and in children (aged 1 to 17 years.
Time frame: Baseline and at 28 days post the second dose of either CCV with alum, CCV without alum or placebo
GMT of IgG antibody responses to OSP against V. cholerae O1 Inaba at 28 days after two doses of CCV 25 μg (with or without alum).or placebo in adults (aged 18 to 45 years) and in children (aged 1 to 17 years.
Time frame: Baseline and at 28 days post the second dose of either CCV with alum, CCV without alum or placebo]
GMT of Serum vibriocidal antibody titers against V. cholerae O1 Inaba and O1 Ogawa at 28 days after booster dose in heterologous boosting group of CCV with or without alum 25 μg and Euvichol®-Plus in children aged 1 to 4 years
Time frame: Baseline and at 28 days post the heterologous booster dose
GMT of IgG antibody responses to OSP against V. cholerae O1 Inaba at 28 days after booster dose in heterologous boosting group of CCV with or without alum 25 μg and Euvichol®-Plus in children aged 1 to 4 years
Time frame: Baseline and at 28 days post the heterologous booster dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julia Lynch, MD principal investigator
International Vaccine Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OSP:rTTHc CCV 25 ㎍ with Aluminum phosphate, OSP:rTTHc CCV 25 ㎍ without Aluminum phosphate and Euvichol®-Plus in people with Cholera Vaccination, run by International Vaccine Institute at 1 site in Kenya.
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 4 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Naveena D'Cor, MD (+82 2 8811 000, naveena.dcor@ivi.int), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroconversion of Serum vibriocidal antibody titers responses to V. cholerae O1 Inaba and O1 Ogawa at 28 days after one dose vaccination of CCV 25 μg (with or without alum) in adults (aged 18 to 45 years) and in children (aged 1 to 17 years). (time frame: Baseline and at 28 days post the first dose of either CCV with alum, CCV without alum or placebo). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2026.