Digestive System Cholera
Conditions
Interventions
Sponsors
International Vaccine Institute IVI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Individuals aged 1 to 45 years at consent 2. Participants/ Participants’ legally authorized representative (LAR) willing to provide written informed consent to participate in the study voluntarily 3. Participants who can comply with the study requirements 4. Individuals in good health as determined by the outcome of medical history, physical examination, and the clinical judgment of the investigator
Exclusion criteria
Exclusion criteria: 1. Known history or allergy to investigational vaccine components 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 2. Individuals with major congenital abnormalities which in the opinion of investigator may affect the participant’s participation in the study 3. Known history of immune function disorders including immunodeficiency diseases (known HIV infection¥ or other immune function disorders) which in the opinion of investigator may affect the participant’s participation in the study or interfere with the assessment of the study objectives 4. 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. 5. 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 6. 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 7. Individuals with splenectomy 8. Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time resulting in contraindication for IM injections/blood extractions 9. Receipt of blood, blood-derived products, or immunoglobulin products in the past 3 months 10. 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. 11. Individuals with active or known previous Vibrio cholerae infection 12. Individuals with a history of severe diarrhea requiring hospitalization or emergency room visit within the last 5yr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| oSerum vibriocidal antibody titers against V. cholerae O1 Inaba and O1 Ogawa at 28 days after one dose vaccination of CCV (with or without alum) 25 µg / placebo in adults aged 18 to 45 years and in children aged 5 to 17 years. oSerum vibriocidal antibody titers against V. cholerae O1 Inaba and O1 Ogawa at 28 days after one dose vaccination of CCV (with or without alum) 25 µg or at 14 days after two doses of Euvichol®-Plus in children aged 1 to 4 years oIgG antibody responses to O-specific polysaccharide (OSP) using ELISA, against V. cholerae O1 Inaba at 28 days after one dose vaccination of CCV (with or without alum) 25 µg / placebo in adults aged 18 to 45 years and in children aged 5 to 17 years | — |
Secondary
| Measure | Time frame |
|---|---|
| o Serum vibriocidal antibody titers against V. cholerae O1 Inaba and O1 Ogawa at 28 days after second dose vaccination of CCV (with or without alum) 25 µg / placebo in adults aged 18 to 45 years and in children aged 1 to 17 years o Serum vibriocidal antibody titers against V. cholerae O1 Inaba and O1 Ogawa 28 days after the heterologous booster dose in children aged 1 to 4 years o IgG antibody responses to OSP using ELISA, against V. cholerae O1 Inaba at 28 days after second dose vaccination of CCV (with or without alum) 25 µg / placebo in adults aged 18 to 45 years and in children aged 1 to 17 years o IgG antibody responses to OSP using ELISA, against V. cholerae O1 Inaba 28 days after the heterologous booster dose in children aged 1 to 4 years | — |
Countries
Kenya
Contacts
Public ContactJulia Lynch
Snr. Director Cholera IVI
Outcome results
None listed