Cholera VaccinationPhase 3NCT07304284
Trial to Evaluate Immunogenicity Non-Inferiority, Safety and Lot-to-Lot Consistency of Biovac OCV-S to Euvichol®-Plus
A Phase 3 study testing Experimental: Biovac OCV-S (inactivated whole-cell monovalent (O1) oral cholera vaccine) and Active Comparator, Euvichol®-Plus in people with Cholera Vaccination, run by International Vaccine Institute at 5 sites in South Africa.
Trial summary
This Phase I/III clinical trial is intended to establish the immunogenicity and safety profile of Biovac OCV-S compared to available WHO pre-qualified vaccine Euvichol®-Plus in healthy adults and children and in adult people living with HIV (PLWH). 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?
- Experimental: Biovac OCV-S (inactivated whole-cell monovalent (O1) oral cholera vaccine) and Active Comparator, Euvichol®-Plus
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,824 participants
- Where
- 5 sitesSouth Africa
- Study dates
- 31 Oct 2025to Feb 2027
- Phase
- Phase 3
- 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
- Inclusion Criteria (for healthy/HIV-negative cohorts A, B and C)
- Healthy participants aged 1 to 45 years at consent
- Participants/Parent(s)/Legally Authorized Representative (LAR) willing to provide informed consent/assent
- HIV negative
- Not pregnant or lactating
- PLWH adults aged 18 to 45 years at consent
- Participants on anti-retroviral (ARV) therapy with CD4 counts >350 and viral loads that are undetectable.
- Not pregnant or lactating
Who cannot join
- Known history or allergy to investigational vaccine components, other preventive vaccines, or any other allergies
- Individuals with major congenital abnormalities
- Known history of immune function disorders including immunodeficiency diseases (known HIV infection in healthy participant cohorts) or other immune function disorders (all cohorts).
- 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.
- Behavioral or cognitive impairment, chronic substance abuse, or psychiatric disease or neurological disorders.
- Individuals with a known bleeding disorder.
Show all 10Show fewer
- 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 or within 4 weeks after any dose of the investigational product.
- Individuals with active or previous Vibrio cholerae infection.
- Individuals with receipt of a cholera vaccine in the past 5 years.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Dr. Naveena D'Cor Project Technical Lead / Study Medical Monitor, MD contact
Beverley Cowper Medical Consultant, MD contact
5 sites in 1 country
South Africa5 sites, 5 recruiting
- Not yet recruiting
Synergy Biomed Research Institute
Durban, Eastern Cape, 5201
Mookho Malahleha Principal Investigator, 0437222306, drmookho@sbri.org.za
- Recruiting
SAMRC Chatworth CRS
Durban, KwaZulu-Natal, 4092
Logashvari Naidoo Principal Investigator, 0314014150, logashvari.naidoo@mrc.ac.za
- Not yet recruiting
SAMRC Isipingo CRS
Durban, KwaZulu-Natal, 4110
Vimla Naicker Principal Investigator, 0319027494, vimla.naicker@mrc.ac.za
- Recruiting
Perinatal HIV Research Unit (PHRU)
Johannesburg, Gauteng, 1862
Ravindre Panchia Principal Investigator, 011-989-9711, panchiar@phru.co.za
- Not yet recruiting
Wits Vaccines & Infectious Diseases Analytics (VIDA) Research Unit
Johannesburg, Gauteng, 1862
Christopher Stavrou Principal Investigator, +27 11 983 4283, christopher.stavrou@wits-vida.org
About this study
Official title: Phase I/III, Multicenter, Observer-Blinded, Randomized, Active Controlled Trial to Evaluate Immunogenicity Non-Inferiority, Safety and Lot-to-Lot Consistency of Biovac OCV-S to Euvichol®-Plus in 1 to 45 Years Old South Africans
This Phase I/III clinical trial is intended to establish the immunogenicity and safety profile of Biovac OCV-S compared to available WHO pre-qualified vaccine Euvichol®-Plus in healthy adults and children and in adult people living with HIV (PLWH). The lot-to-lot consistency of Biovac OCV-S in healthy adults will also be determined.
Read the detailed description
This is a phase I/III, multicenter, observer-blinded, age-descending, randomized, active controlled trial being conducted in South Africa to evaluate the immunogenicity non-inferiority and safety of Biovac OCV-S compared to Euvichol®-Plus among adults and children, and to evaluate the lot-to-lot consistency of Biovac OCV-S in adults.
A total of 2824 participants aged 1-45 years will be enrolled in the study in 4 cohorts: cohort A (1272 healthy adults aged 18-45 years), cohort AA (160 people living with HIV (PLWH) aged 18-45 years), cohort B (696 healthy children aged 6-17 years), and cohort C (696 healthy children aged 1-5 years). Participants in cohort A will be randomized into 4 arms to receive either one of the 3 lots of Biovac OCV-S or to receive the comparator Euvichol®-Plus in 1:1:1:1 ratio. Participants in cohorts AA, B and C will each be randomized into 2 arms to receive either Biovac OCV-S or Euvichol®-Plus in 3:1 ratio.
Each of the study participants will receive the assigned investigational product Biovac OCV-S or Euvichol®-Plus given orally in 2 doses at 2 weeks interval and will be followed up for safety and immunogenicity at specific time points. Each participant will be in the study for approximately 27 weeks.
- Conditions
- Cholera Vaccination
- Being tested
- Experimental: Biovac OCV-S (inactivated whole-cell monovalent (O1) oral cholera vaccine), Active Comparator, Euvichol®-Plus
- Keywords
- Biovac OCV-S, Euvichol®-Plus, IVI BIOVAC OCV-S 001, International Vaccine Institute (IVI), Biovac Institute, South African Medical Research Council (SAMRC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Biovac OCV-S (inactivated whole-cell monovalent (O1) oral cholera vaccine)Biological
Two doses (1.5mL) at two weeks interval given orally.
Active Comparator, Euvichol®-PlusBiological
Two doses (1.5mL) at two weeks interval given orally.
| Study group | Role | What they receive |
|---|---|---|
| Arm A1: Biovac OCV-S | Experimental | Biovac OCV-S (Lot 1), HIV Negative Group, 18-45 years Receives: Biological: Experimental: Biovac OCV-S (inactivated whole-cell monovalent (O1) oral cholera vaccine) |
| Arm A2: Biovac OCV-S | Experimental | Biovac OCV-S (Lot 2), HIV Negative Group, 18-45 years Receives: Biological: Experimental: Biovac OCV-S (inactivated whole-cell monovalent (O1) oral cholera vaccine) |
| Arm A3: Biovac OCV-S | Experimental | Biovac OCV-S (Lot 3), HIV Negative Group, 18-45 years Receives: Biological: Experimental: Biovac OCV-S (inactivated whole-cell monovalent (O1) oral cholera vaccine) |
| Arm A4: Euvichol®-Plus | Active comparator | Euvichol®-Plus, HIV Negative Group, 18-45 years Receives: Biological: Active Comparator, Euvichol®-Plus |
| Arm B1: Biovac OCV-S | Experimental | Biovac OCV-S, HIV Negative Group, 6-17 years Receives: Biological: Experimental: Biovac OCV-S (inactivated whole-cell monovalent (O1) oral cholera vaccine) |
| Arm B2: Euvichol®-Plus | Active comparator | Euvichol®-Plus, HIV Negative Group, 6-17 years Receives: Biological: Active Comparator, Euvichol®-Plus |
| Arm C1: Biovac OCV-S | Experimental | Biovac OCV-S, HIV Negative Group, 1-5 years Receives: Biological: Experimental: Biovac OCV-S (inactivated whole-cell monovalent (O1) oral cholera vaccine) |
| Arm C2: Euvichol®-Plus | Active comparator | Euvichol®-Plus, HIV Negative Group, 1-5 years Receives: Biological: Active Comparator, Euvichol®-Plus |
| Arm AA1: Biovac OCV-S | Experimental | Biovac OCV-S, People living with HIV, 18-45 years Receives: Biological: Experimental: Biovac OCV-S (inactivated whole-cell monovalent (O1) oral cholera vaccine) |
| Arm AA2: Euvichol®-Plus | Active comparator | Euvichol®-Plus, People living with HIV, 18-45 years Receives: Biological: Active Comparator, Euvichol®-Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion of vibriocidal titers against Vibrio cholerae O1 Inaba and O1 Ogawa
Proportion of participants showing seroconversion of vibriocidal titers against Vibrio cholerae O1 Inaba and O1 Ogawa (seroconversion is defined as at least 4-fold increase of vibriocidal titers compared to baseline) at 2 weeks after second dose of either Biovac OCV-S (i.e., one lot of Biovac OCV-S) or Euvichol®-Plus for all ages, in the HIV negative group.
Measured: 2 weeks after second dose of either Biovac OCV-S (i.e., one lot of Biovac OCV-S) or Euvichol®-Plus
Incidence of Treatment-Emergent Adverse Events in the HIV negative group
Safety of each investigational product dose at a specified duration in the HIV negative group:
- Occurrence of any Serious Adverse Event (SAE)/ Adverse Event of Special Interest (AESI)/ Medically Attended Adverse Event (MAAE) from the first dose vaccination throughout the final study visit
- Occurrence of immediate adverse events within 30 minutes after each dose vaccination
- Occurrence of solicited adverse events within 7 days after each dose vaccination
- Occurrence of unsolicited adverse events within 14 days after each dose vaccination
Measured: Within 14 days after each vaccination
Secondary outcomes (4)
Geometric Mean Titer (GMT) of vibriocidal antibodies against Vibrio cholerae O1 Inaba and Ogawa for all ages
GMT of vibriocidal antibodies against Vibrio cholerae O1 Inaba and Ogawa 2 weeks after second dose of either Biovac OCV-S (i.e., one lot of Biovac OCV-S) or Euvichol®-Plus for all ages, in the HIV negative group.
Measured: 2 weeks after second dose of either Biovac OCV-S (i.e., one lot of Biovac OCV-S) or Euvichol®-Plus
Proportion of participants showing seroconversion against Vibrio cholerae O1 Inaba and Ogawa
The proportion of participants showing seroconversion against Vibrio cholerae O1 Inaba and Ogawa 2 weeks after second dose of either Biovac OCV-S (i.e., one lot of Biovac OCV-S) or Euvichol®-Plus in each age stratum, in the HIV negative group.
Measured: 2 weeks after second dose of either Biovac OCV-S (i.e., one lot of Biovac OCV-S) or Euvichol®-Plus
GMT of vibriocidal antibodies against Vibrio cholerae O1 Inaba and Ogawa in each age stratum
GMT of vibriocidal antibodies against Vibrio cholerae O1 Inaba and Ogawa 2 weeks after second dose of either Biovac OCV-S (i.e., one lot of Biovac OCV-S) or Euvichol®-Plus in each age stratum, in the HIV negative group.
Measured: 2 weeks after second dose of either Biovac OCV-S (i.e., one lot of Biovac OCV-S) or Euvichol®-Plus
GMT of vibriocidal antibodies against Vibrio cholerae O1 Inaba and Ogawa in adults
GMT of vibriocidal antibodies against Vibrio cholerae O1 Inaba and Ogawa 2 weeks after second dose of 3 lots of Biovac OCV-S in adults in the HIV negative group.
Measured: 2 weeks after second dose of 3 lots of Biovac OCV-S
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start31 Oct 2025
- Primary completionDec 2026 (estimated)
- Study completionFeb 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,824 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Vaccine Institute
- Sponsor type
- University, hospital or other
- Collaborators
- BioVac, Medical Research Council, South Africa
- Responsible party
- Sponsor
- Investigators
- Tarun Saluja, MD, Principal investigator, International Vaccine InstituteGlenda Gray, MD, Principal investigator, Medical Research Council, South AfricaJulia Lynch, MD, Study director, International Vaccine Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304284
- Sponsor's protocol ID
- IVI BIOVAC OCV-S 001
- Status last verified
- Jan 2026
- First submitted
- 11 Dec 2025
- Last updated
- 12 Jan 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 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/III, Multicenter, Observer-Blinded, Randomized, Active Controlled Trial to Evaluate Immunogenicity Non-Inferiority, Safety and Lot-to-Lot Consistency of Biovac OCV-S to Euvichol®-Plus in 1 to 45 Years Old South Africans
- ClinicalTrials.gov ID
- NCT07304284
- Acronym / sponsor ID
- IVI BIOVAC OCV-S 001
- Conditions
- Cholera Vaccination
- Keywords
- Biovac OCV-S, Euvichol®-Plus, IVI BIOVAC OCV-S 001, International Vaccine Institute (IVI), Biovac Institute, South African Medical Research Council (SAMRC)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,824 participants (estimated)
- Lead sponsor
- International Vaccine InstituteUniversity, hospital or other
- Collaborators
- BioVac, Medical Research Council, South Africa
- Study start
- 31 Oct 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 26 Dec 2025 (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 I/III clinical trial is intended to establish the immunogenicity and safety profile of Biovac OCV-S compared to available WHO pre-qualified vaccine Euvichol®-Plus in healthy adults and children and in adult people living with HIV (PLWH). The lot-to-lot consistency of Biovac OCV-S in healthy adults will also be determined.
Detailed description
This is a phase I/III, multicenter, observer-blinded, age-descending, randomized, active controlled trial being conducted in South Africa to evaluate the immunogenicity non-inferiority and safety of Biovac OCV-S compared to Euvichol®-Plus among adults and children, and to evaluate the lot-to-lot consistency of Biovac OCV-S in adults.
A total of 2824 participants aged 1-45 years will be enrolled in the study in 4 cohorts: cohort A (1272 healthy adults aged 18-45 years), cohort AA (160 people living with HIV (PLWH) aged 18-45 years), cohort B (696 healthy children aged 6-17 years), and cohort C (696 healthy children aged 1-5 years). Participants in cohort A will be randomized into 4 arms to receive either one of the 3 lots of Biovac OCV-S or to receive the comparator Euvichol®-Plus in 1:1:1:1 ratio. Participants in cohorts AA, B and C will each be randomized into 2 arms to receive either Biovac OCV-S or Euvichol®-Plus in 3:1 ratio.
Each of the study participants will receive the assigned investigational product Biovac OCV-S or Euvichol®-Plus given orally in 2 doses at 2 weeks interval and will be followed up for safety and immunogenicity at specific time points. Each participant will be in the study for approximately 27 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Arm A1: Biovac OCV-S | Experimental | Biological: Experimental: Biovac OCV-S (inactivated whole-cell monovalent (O1) oral cholera vaccine)Biovac OCV-S (Lot 1), HIV Negative Group, 18-45 years |
| Arm A2: Biovac OCV-S | Experimental | Biological: Experimental: Biovac OCV-S (inactivated whole-cell monovalent (O1) oral cholera vaccine)Biovac OCV-S (Lot 2), HIV Negative Group, 18-45 years |
| Arm A3: Biovac OCV-S | Experimental | Biological: Experimental: Biovac OCV-S (inactivated whole-cell monovalent (O1) oral cholera vaccine)Biovac OCV-S (Lot 3), HIV Negative Group, 18-45 years |
| Arm A4: Euvichol®-Plus | Active comparator | Biological: Active Comparator, Euvichol®-PlusEuvichol®-Plus, HIV Negative Group, 18-45 years |
| Arm B1: Biovac OCV-S | Experimental | Biological: Experimental: Biovac OCV-S (inactivated whole-cell monovalent (O1) oral cholera vaccine)Biovac OCV-S, HIV Negative Group, 6-17 years |
| Arm B2: Euvichol®-Plus | Active comparator | Biological: Active Comparator, Euvichol®-PlusEuvichol®-Plus, HIV Negative Group, 6-17 years |
| Arm C1: Biovac OCV-S | Experimental | Biological: Experimental: Biovac OCV-S (inactivated whole-cell monovalent (O1) oral cholera vaccine)Biovac OCV-S, HIV Negative Group, 1-5 years |
| Arm C2: Euvichol®-Plus | Active comparator | Biological: Active Comparator, Euvichol®-PlusEuvichol®-Plus, HIV Negative Group, 1-5 years |
| Arm AA1: Biovac OCV-S | Experimental | Biological: Experimental: Biovac OCV-S (inactivated whole-cell monovalent (O1) oral cholera vaccine)Biovac OCV-S, People living with HIV, 18-45 years |
| Arm AA2: Euvichol®-Plus | Active comparator | Biological: Active Comparator, Euvichol®-PlusEuvichol®-Plus, People living with HIV, 18-45 years |
Who may qualify
- Ages
- 1 year to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Inclusion Criteria (for healthy/HIV-negative cohorts A, B and C)
- Healthy participants aged 1 to 45 years at consent
- Participants/Parent(s)/Legally Authorized Representative (LAR) willing to provide informed consent/assent
- HIV negative
- Not pregnant or lactating
Key exclusion criteria (10 listed)
- Known history or allergy to investigational vaccine components, other preventive vaccines, or any other allergies
- Individuals with major congenital abnormalities
- Known history of immune function disorders including immunodeficiency diseases (known HIV infection in healthy participant cohorts) or other immune function disorders (all cohorts).
- 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.
- Behavioral or cognitive impairment, chronic substance abuse, or psychiatric disease or neurological disorders.
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 |
|---|---|---|
| Experimental: Biovac OCV-S (inactivated whole-cell monovalent (O1) oral cholera vaccine)Two doses (1.5mL) at two weeks interval given orally. | Biological | Arm A1: Biovac OCV-S, Arm A2: Biovac OCV-S, Arm A3: Biovac OCV-S, Arm AA1: Biovac OCV-S, Arm B1: Biovac OCV-S, Arm C1: Biovac OCV-S |
| Active Comparator, Euvichol®-PlusTwo doses (1.5mL) at two weeks interval given orally. | Biological | Arm A4: Euvichol®-Plus, Arm AA2: Euvichol®-Plus, Arm B2: Euvichol®-Plus, Arm C2: Euvichol®-Plus |
Primary outcome
Seroconversion of vibriocidal titers against Vibrio cholerae O1 Inaba and O1 Ogawa
Time frame: 2 weeks after second dose of either Biovac OCV-S (i.e., one lot of Biovac OCV-S) or Euvichol®-Plus
Proportion of participants showing seroconversion of vibriocidal titers against Vibrio cholerae O1 Inaba and O1 Ogawa (seroconversion is defined as at least 4-fold increase of vibriocidal titers compared to baseline) at 2 weeks after second dose of either Biovac OCV-S (i.e., one lot of Biovac OCV-S) or Euvichol®-Plus for all ages, in the HIV negative group.
Incidence of Treatment-Emergent Adverse Events in the HIV negative group
Time frame: Within 14 days after each vaccination
Safety of each investigational product dose at a specified duration in the HIV negative group: 1. Occurrence of any Serious Adverse Event (SAE)/ Adverse Event of Special Interest (AESI)/ Medically Attended Adverse Event (MAAE) from the first dose vaccination throughout the final study visit 2. Occurrence of immediate adverse events within 30 minutes after each dose vaccination 3. Occurrence of solicited adverse events within 7 days after each dose vaccination 4. Occurrence of unsolicited adverse events within 14 days after each dose vaccination
4 secondary outcomes
Geometric Mean Titer (GMT) of vibriocidal antibodies against Vibrio cholerae O1 Inaba and Ogawa for all ages
Time frame: 2 weeks after second dose of either Biovac OCV-S (i.e., one lot of Biovac OCV-S) or Euvichol®-Plus
Proportion of participants showing seroconversion against Vibrio cholerae O1 Inaba and Ogawa
Time frame: 2 weeks after second dose of either Biovac OCV-S (i.e., one lot of Biovac OCV-S) or Euvichol®-Plus
GMT of vibriocidal antibodies against Vibrio cholerae O1 Inaba and Ogawa in each age stratum
Time frame: 2 weeks after second dose of either Biovac OCV-S (i.e., one lot of Biovac OCV-S) or Euvichol®-Plus
GMT of vibriocidal antibodies against Vibrio cholerae O1 Inaba and Ogawa in adults
Time frame: 2 weeks after second dose of 3 lots of Biovac OCV-S
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 12 Jan 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.
Dr. Naveena D'Cor Project Technical Lead / Study Medical Monitor, MD contact
Beverley Cowper Medical Consultant, MD contact
Tarun Saluja, MD principal investigator
International Vaccine Institute
Glenda Gray, MD principal investigator
Medical Research Council, South Africa
Julia Lynch, MD study director
International Vaccine Institute
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Experimental: Biovac OCV-S (inactivated whole-cell monovalent (O1) oral cholera vaccine) and Active Comparator, Euvichol®-Plus in people with Cholera Vaccination, run by International Vaccine Institute at 5 sites in South Africa.
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 8 inclusion and 10 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 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Africa. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Dr. Naveena D'Cor Project Technical Lead / Study Medical Monitor, 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 vibriocidal titers against Vibrio cholerae O1 Inaba and O1 Ogawa (time frame: 2 weeks after second dose of either Biovac OCV-S (i.e., one lot of Biovac OCV-S) or Euvichol®-Plus). The study lists 2 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 12 Jan 2026.