Status:
COMPLETED
Effect of Extended Dose Intervals on the Immune Response to Oral Cholera Vaccine
Lead Sponsor:
Johns Hopkins Bloomberg School of Public Health
Conditions:
Cholera
Vibrio Cholerae Infection
Eligibility:
All Genders
1+ years
Phase:
PHASE4
Brief Summary
Cholera is a life-threatening disease if prompt actions are not taken. The most recent estimates of the global burden of cholera estimate that there are more than 1.3 billion people at risk. Of which,...
Detailed Description
Cholera is a life-threatening disease if prompt actions are not taken. The most recent estimates of the global burden of cholera estimate that there are more than 1.3 billion people at risk. Of which,...
Eligibility Criteria
Inclusion
- Age ≥1 year, stratified into different age groups
- Living in the Waya Clinic Catchment 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 9 months from screening.
- Signed informed consent
Exclusion
- 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.
Key Trial Info
Start Date :
November 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03373669
Start Date
November 16 2017
End Date
December 1 2020
Last Update
April 5 2021
Active Locations (1)
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1
Center for Infectious Disease Research - Zambia
Lusaka, Zambia