Cholera
Conditions
Interventions
Second dose at two weeks
Second dose at three months
Second dose at one year
Sponsors
Sabin Vaccine Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Residents of Mukuru, Nairobi, Kenya Individuals aged 1 year and above Voluntary written informed consent for study participation provided by an individual or his/her legally acceptable representative. Children aged 13 years and above will also provide assent, with parental permission required for all children. Ability to comply with study requirements and attend follow-up visits during the study period. In good health, as determined by medical history, physical examination, and the clinical judgment of the investigators. Clinical judgment will consider factors such as the absence of acute illness or, uncontrolled or severe chronic conditions that may affect participation in the study
Exclusion criteria
Exclusion criteria: Known history of hypersensitivity reactions to other vaccines. Pregnant women, due to differences in immune response. A pregnancy test will be administered to all female participants between 15-49 years. Reported diarrhea or abdominal pain lasting 2 weeks or longer within 6 months prior to study initiation; to avoid confounding the vaccine's effects with pre-existing conditions. Received a cholera vaccine in the last 24 months: Ensures that the study assesses the vaccine in question without interference from prior vaccinations. History of cholera disease in the last 24 months: Recent history of cholera infection can interfere with the measurement of vaccine response. Severely malnourished individuals as determined by mid-upper arm circumference (MUAC) and age-specific body mass index (BMI) measurements: malnutrition can affect immune response and vaccine efficacy. In children below 10 years, severe malnutrition will be defined as MUAC < 11.5 cm, while in older children and adults it will be defined as BMI < 16. Non-HIV/AIDS immunosuppressive condition or on immunosuppressive therapy: Such conditions can significantly alter vaccine response. Presence of bleeding disorders or medical contraindication for blood draws: To ensure participant safety during blood collection. Participation in another clinical trial with investigational product dosing within 6 months prior to study initiation. Difficulty in participating in the study due to severe chronic diseases, based on the judgment of the investigator. Difficulty participating in the study due to reasons, such as significant logistical constraints, or communication barriers, or likely to be away for a period of at least 3 consecutive months in the first 6 months of enrollment based on the judgment of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vibriocidal geometric mean titer in plasma | — |
Secondary
| Measure | Time frame |
|---|---|
| Vibriocidal geometric mean titer in plasma by age stratum;Vibriocidal antibody seroconversion;Longitudinal changes in geometric mean titer;Incidence of lab-confirmed cholera disease;Safety profile assessment | — |
Countries
Kenya
Contacts
Public ContactDenise;Samuel Garrett;Kariuki
Sabin Vaccine Institute;KEMRI
Outcome results
None listed