Extended Dose Intervals With Oral Cholera Vaccine in Cameroon (NCT03719066) | Clinical Trial Compass
CompletedPhase 2
Extended Dose Intervals With Oral Cholera Vaccine in Cameroon
Cameroon181 participantsStarted 2018-10-23
Plain-language summary
The primary aim of this project is to determine changes in the vibriocidal geometric mean titers (GMT) in subjects who receive the second dose of oral cholera vaccine (OCV) at different intervals: 2 weeks, 6 months, or 11 months following the first dose of vaccine. Secondary aims include a) vibriocidal antibody response rates in subjects who receive OCV at 2 weeks, 6 months, or 11 months following the first dose of vaccine, b) age specific serum vibriocidal GMTs following the second dose among participants given the second dose of OCV at intervals of 2 weeks, 6 months, or 11 months following the first dose of vaccine, c) GMT and antibody response rates of Immunoglobulin A (IgA) and Immunoglobulin G (IgG) anti-lipopolysaccharide (LPS) as measured by ELISA following the second dose among participants given the second dose of OCV at intervals of 2 weeks, 6 months, or 11 months following the first dose of vaccine. The hypothesis is that the vibriocidal GMT following the second dose, when given after 6 or 12 months will not be inferior to the response when the second dose is given according to the standard interval of two weeks.
Who can participate
Age range1 Year
SexALL
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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).
What they're measuring
1
Vibriocidal titer
Timeframe: two weeks after the second dose
Trial details
NCT IDNCT03719066
SponsorJohns Hopkins Bloomberg School of Public Health