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| Name | Class |
|---|---|
| EuBiologics Co.,Ltd | INDUSTRY |
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Number of doses and intervals: Two doses, 2 weeks apart
Method of administration: Oral administration
Volume of vaccine to be administered: 1.5 mL/dose
Observational period: 4 weeks (2 weeks after each dose)
Number of visits: 3 visits
This study is observer-blind: vaccine administrator and vaccine safety evaluator will be two distinct persons to avoid bias of safety assessment. Trial staff other than the vaccine administrator will remain blinded and will not handle the investigational product.
Primary immunogenicity endpoint
Secondary immunogenicity endpoints
Proportion of participants with:
Immediate reactions within 30 minutes after each dose of vaccination.
Solicited systemic Adverse Events: nausea/vomiting, diarrhea, headache, fatigue, myalgia, fever, and anorexia/loss of appetite within 7 days after each vaccination.
Unsolicited Adverse Events and Serious Adverse Events occurring 14 days following each vaccination, as reported by participants Measurement of Geometric Mean Titer of vibriocidal antibodies post vaccination, Ratio ofGeometric Mean Titer of vibriocidal antibodies post vaccination of Test vaccine' compared with 'Comparator vaccine'.
Expected outcome: Statistical equivalence of the two vaccines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group | Experimental | Test Oral Cholera Vaccine |
|
| comparator group | Active Comparator | Euvichol® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Oral Cholera Vaccine | Biological | Thimerosal free, manufactured at 600 L scale killed bivalent (O1 and O139) whole cell-oral cholera vaccine (WC-OCV) manufactured by Eubiologics Co., Ltd. |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity endpoint for Inaba O1 | Geometric Mean Titer (GMT) of Vibriocidal antibodies against Inaba serogroup O1 post second dose | 28 days |
| Immunogenicity endpoint for Ogawa O1 | GMTof Vibriocidal antibodies against Ogawa serogroup O1 post second dose | 28 days |
| Immunogenicity endpoint O139 | GMT of Vibriocidal antibodies against serogroup O139 post second dose | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants showing seroconversion against Inaba serogroup O1, Ogawa serogroup O1and serogroup O139 post vaccinations. | 28 days | |
| Seroconversion is defined as 4-fold rise in vibriocidal antibody titer at Visit 3 two weeks after the second dose, compared to baseline titers, measured at Visit 1 prior to vaccination. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Digilio, MD | Contact | +82-2-881-1363 | 363 | Laura.Digilio@ivi.int |
| Sung Hee Lee, Msc | Contact | +82-2-881-1431 | 431 | sungheelee@ivi.int |
| Name | Affiliation | Role |
|---|---|---|
| Laura Digilio, MD | International Vaccince Institute | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29895500 | Derived | Russo P, Ligsay AD, Olveda R, Choi SK, Kim DR, Park JY, Park JY, Syed KA, Dey A, Kim YH, Lee SH, Kim J, Chon Y, Digilio L, Kim CW, Excler JL. A randomized, observer-blinded, equivalence trial comparing two variations of Euvichol(R), a bivalent killed whole-cell oral cholera vaccine, in healthy adults and children in the Philippines. Vaccine. 2018 Jul 5;36(29):4317-4324. doi: 10.1016/j.vaccine.2018.05.102. Epub 2018 Jun 9. |
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| ID | Term |
|---|---|
| D002771 | Cholera |
| ID | Term |
|---|---|
| D014735 | Vibrio Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| Euvichol® | Biological | Licensed, manufactured at 100 L scale killed bivalent (O1 and O139) whole cell-oral cholera vaccine (WC-OCV) manufactured by Eubiologics Co., Ltd. |
|
| 28 days |
| D007239 | Infections |