Adverse Reaction to Cholera Vaccine, Cholera Vaccination Reaction
Conditions
Keywords
cholera, oral cholera vaccine, vibriocidal titer, ELISA antibodies, Adverse event following immunization
Brief 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.
Detailed description
This is an open label, randomized, phase 2 clinical trial of the immunogenicity of killed oral cholera vaccine (OCV) when the vaccine is administered to participants of three age cohorts (1-4 years, 5-14 years, and \>14 years) and in three dose interval groups (DIGs). The subjects in each age cohort will be randomized to a DIG of 2 weeks (DIG-1), 6 months (DIG-2) or 11 months (DIG-3). A total of 180 subjects from Douala, Cameroon will be enrolled and these are equally divided between the different groups (20 per age/dose interval group). The OCV to be used in the trial is Shanchol. Blood samples will be collected before the first dose and at intervals following the first dose depending on the dosing interval group assigned. The serum (or plasma) will be tested for antibodies to cholera.
Interventions
BIOLOGICALkilled whole cell oral cholera vaccine
two week interval
Sponsors
Bill and Melinda Gates Foundation
Meilleur Accès aux Soins de Santé (M.A. Santé)
Johns Hopkins Bloomberg School of Public Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Subjects will be randomized to receive two doses of Shanchol oral cholera vaccine with dose intervals of either 2 weeks, 6 months or 11 months.
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age ≥1 year, stratified into different age groups 2. Living in the Soboum Health Area or adjoining area 3. Good health condition, without clinically significant medical history (by participant or guardian, in case of minor) 4. Not pregnant for female subjects. 5. Available to participate for the study duration, including all planned follow-up visits for up to 18 months from screening. 6. Signed informed consent -
Exclusion criteria
1. 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) 2. Ever having received oral cholera vaccine. 3. Receipt of an investigational product (within 30 days before vaccination). 4. History of diarrhoea in 7 days prior to first dose of vaccine (defined as ≥3 unformed loose stools in 24 hours). 5. History of chronic diarrhea (lasting for more than 2 weeks in the past 6 months) 6. Current use of laxatives, antacids, or other agents to lower stomach acidity? 7. Planning to become pregnant in the next 2 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vibriocidal titer | two weeks after the second dose | Geometric Mean titre of the vibriocidal titre |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ELISA titres | two weeks after the second dose | IgG and IgA geometric mean titres against V cholerae LPS |
Countries
Cameroon
Outcome results
None listed