Cholera
Conditions
Interventions
Vaccine
Sponsors
MSF OCB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Any healthy individual = 1 year-old and younger than 40 years old , eligible for OCV vaccination (not suffering from a medical condition that contraindicates vaccination, i.e. any acute illness, including acute gastrointestinal illness or acute febrile illness). Living in the study area with no plan to move away over the study period (up to 18 months). Who provided written informed consent or whose representative (mother, father or main caretaker) provided written informed consent in case of individuals younger than 18 years. A written assent will also be obtained from adolescents (10-17 years) An individual who (or whose mother, father or main caretaker) is, based on the judgment of the investigator, capable of complying with the study requirements.
Exclusion criteria
Exclusion criteria: Known history of hypersensitivity reactions to other vaccines. Individual acutely ill or with signs of infection at the time of enrolment (e.g. fever > 38°C) Gastrointestinal symptoms including nausea, vomiting, diarrhea, or decreased appetite within 24 hours prior to study initiation . Diarrhea, administration of antidiarrheal drugs or antibiotics to treat diarrhea or abdominal pain either lasting 2 weeks or longer within 6 months prior to study initiation, or occurring during the week before study initiation. Other vaccination within 1 week prior to study initiation or planned vaccination during the following month after vaccine intake . Participation in another trial with investigational product within 1 month prior to study initiation. Pregnant (as determined by a urine test on the day of each vaccination) or lactating women, women of reproductive age planning pregnancy before the end of the study period (up to minimum 18 months). An individual thought to have difficulty participating in the study due to other reasons (such as mental disorders, alcohol or drug intoxication), based on the judgment of the investigator. History of cholera vaccination or history of cholera as diagnosed by a medical person in a health facility (with or without laboratory confirmation). Severe chronic diseases or medical conditions, based on the medical judgment of the investigator, such as known low hemoglobin level or symptomatic anemia, severe acute malnutrition, chronic infection (e.g. tuberculosis), sequel of poliomyelitis, immunodeficiency due to symptomatic HIV/AIDS. Based on participant verbal reporting of the participant at inclusion, more than two persons in households <5 persons or three participants in households = 5 persons. Although unlikely to be diagnosed in low-income countries: Thrombocytopenia or bleeding disorders or other known contraindication to venipuncture. see protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum vibriocidal antibody GMT specific to V. cholerae O1, Inaba, Ogawa and O139 strains The primary analysis will compare the serum vibriocidal antibody GMT 14 days after the administration of the second OCV dose among the control arm (short, 14-day dosing interval of OCV administration) and the intervention arms (long, 6 and 12 months dosing intervals of OCV administration). | — |
Secondary
| Measure | Time frame |
|---|---|
| Kinetics of the immune response to vaccination. All the primary and secondary outcomes will be measured at additional time points in a subset of the participants aged =18 years in the control and intervention arms;Safety and reactogenicity All participants will be observed for 30 minutes after each vaccination to monitor for any immediate adverse events (IAEs). The occurrence of IAEs, AEs and SAEs will be assessed in each vaccine arm.;Immune responses directed against the Inaba, Ogawa and O139 OSP;Serum GMT for specific antibodies against the CtxB | — |
Countries
Guinea
Contacts
Public ContactFabienne Nackers
PI
Outcome results
None listed