Extended Dose Intervals With Oral Cholera Vaccine in Cameroon
Adverse Reaction to Cholera Vaccine, Cholera Vaccination Reaction
About this trial
This is an interventional prevention trial for Adverse Reaction to Cholera Vaccine focused on measuring cholera, oral cholera vaccine, vibriocidal titer, ELISA antibodies, Adverse event following immunization
Eligibility Criteria
Inclusion Criteria:
- Age ≥1 year, stratified into different age groups
- Living in the Soboum Health Area or adjoining area
- Good health condition, without clinically significant medical history (by participant or guardian, in case of minor)
- Not pregnant for female subjects.
- Available to participate for the study duration, including all planned follow-up visits for up to 18 months from screening.
- Signed informed consent -
Exclusion Criteria:
- Presence of a significant medical or psychiatric condition (Examples include: Diagnosis and treatment of tuberculosis (TB) or HIV; renal insufficiency; hepatic disease; oral or parenteral medication known to affect the immune function , such as corticosteroids, other immunosuppressant drugs; or behavioural or memory issues)
- Ever having received oral cholera vaccine.
- Receipt of an investigational product (within 30 days before vaccination).
- History of diarrhoea in 7 days prior to first dose of vaccine (defined as ≥3 unformed loose stools in 24 hours).
- History of chronic diarrhea (lasting for more than 2 weeks in the past 6 months)
- Current use of laxatives, antacids, or other agents to lower stomach acidity?
- Planning to become pregnant in the next 2 years
Sites / Locations
- M.A. Sante
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
DIG 1 (dose interval group)
DIG 2 (dose interval group)
DIG 3 (dose interval group)
This group will receive two doses of killed whole cell oral cholera vaccine. The second dose being administered two weeks after the first dose.
This group will receive two doses of killed whole cell oral cholera vaccine. The second dose being administered 6 months after the first dose.
This group will receive two doses of killed whole cell oral cholera vaccine. The second dose being administered 11 months after the first dose.