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| Name | Class |
|---|---|
| BioVac | UNKNOWN |
| Medical Research Council, South Africa | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A1: Biovac OCV-S | Experimental | Biovac OCV-S (Lot 1), HIV Negative Group, 18-45 years |
|
| Arm A2: Biovac OCV-S | Experimental | Biovac OCV-S (Lot 2), HIV Negative Group, 18-45 years |
|
| Arm A3: Biovac OCV-S | Experimental | Biovac OCV-S (Lot 3), HIV Negative Group, 18-45 years |
|
| Arm A4: Euvichol®-Plus | Active Comparator | Euvichol®-Plus, HIV Negative Group, 18-45 years |
|
| Arm B1: Biovac OCV-S | Experimental | Biovac OCV-S, HIV Negative Group, 6-17 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: Biovac OCV-S (inactivated whole-cell monovalent (O1) oral cholera vaccine) | Biological | Two doses (1.5mL) at two weeks interval given orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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:
| Within 14 days after each vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks after second dose of either Biovac OCV-S (i.e., one lot of Biovac OCV-S) or Euvichol®-Plus |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants showing seroconversion of vibriocidal titers against Vibrio cholerae O1 Inaba and Ogawa | The proportion of participants showing seroconversion of vibriocidal titers 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. | 2 weeks after second dose of 3 lots of Biovac OCV-S |
Inclusion Criteria:
Inclusion Criteria (for healthy/HIV-negative cohorts A, B and C)
Inclusion Criteria (for PLWH (HIV-positive) cohort AA)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Naveena D'Cor Project Technical Lead / Study Medical Monitor, MD | Contact | +82 2 8811 000 | naveena.dcor@ivi.int | |
| Beverley Cowper Medical Consultant, MD | Contact | BeverleyC@biovac.co.za |
| Name | Affiliation | Role |
|---|---|---|
| Tarun Saluja, MD | International Vaccine Institute | Principal Investigator |
| Glenda Gray, MD | Medical Research Council, South Africa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Synergy Biomed Research Institute | Not yet recruiting | Durban | Eastern Cape | 5201 | South Africa |
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| Arm B2: Euvichol®-Plus |
| Active Comparator |
Euvichol®-Plus, HIV Negative Group, 6-17 years |
|
| Arm C1: Biovac OCV-S | Experimental | Biovac OCV-S, HIV Negative Group, 1-5 years |
|
| Arm C2: Euvichol®-Plus | Active Comparator | Euvichol®-Plus, HIV Negative Group, 1-5 years |
|
| Arm AA1: Biovac OCV-S | Experimental | Biovac OCV-S, People living with HIV, 18-45 years |
|
| Arm AA2: Euvichol®-Plus | Active Comparator | Euvichol®-Plus, People living with HIV, 18-45 years |
|
| Active Comparator, Euvichol®-Plus | Biological | Two doses (1.5mL) at two weeks interval given orally. |
|
| 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. | 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. | 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. | 2 weeks after second dose of 3 lots of Biovac OCV-S |
| Seroconversion rate and GMT of vibriocidal antibodies | Seroconversion rate and GMT of vibriocidal antibodies 2 weeks after first dose of either Biovac OCV-S or Euvichol®-Plus for all ages and for each age stratum, in the HIV negative group. | 2 weeks after first dose of either Biovac OCV-S or Euvichol®-Plus |
| Seroconversion rate and GMT of vibriocidal antibodies | Seroconversion rate and GMT of vibriocidal antibodies 2 weeks after one and two doses of Biovac OCV-S and Euvichol®-Plus for adults, in the PLWH group. | 2 weeks after one and two doses of Biovac OCV-S and Euvichol®-Plus |
| Incidence of Treatment-Emergent Adverse Events in the PLWH group | Safety of each investigational product dose at a specified duration in the PLWH group:
| Within 14 days after each dose vaccination |
| Julia Lynch, MD |
| International Vaccine Institute |
| Study Director |
| Perinatal HIV Research Unit (PHRU) | Recruiting | Johannesburg | Gauteng | 1862 | South Africa |
|
| Wits Vaccines & Infectious Diseases Analytics (VIDA) Research Unit | Not yet recruiting | Johannesburg | Gauteng | 1862 | South Africa |
|
| SAMRC Chatworth CRS | Recruiting | Durban | KwaZulu-Natal | 4092 | South Africa |
|
| SAMRC Isipingo CRS | Not yet recruiting | Durban | KwaZulu-Natal | 4110 | South Africa |
|
| ID | Term |
|---|---|
| D022121 | Cholera Vaccines |
| ID | Term |
|---|---|
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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