Extended Dose Intervals With Oral Cholera Vaccine in Cameroon

NCT ID: NCT03719066

Last Updated: 2022-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 181 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-23
• Study Completion Date: 2021-10-05

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.

Conditions

Adverse Reaction to Cholera Vaccine; Cholera Vaccination Reaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

DIG 1 (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.

Group Type: ACTIVE_COMPARATOR

killed whole cell oral cholera vaccine

Intervention Type: BIOLOGICAL

two week interval

DIG 2 (dose interval group)

This group will receive two doses of killed whole cell oral cholera vaccine. The second dose being administered 6 months after the first dose.

Group Type: EXPERIMENTAL

killed whole cell oral cholera vaccine

Intervention Type: BIOLOGICAL

two week interval

DIG 3 (dose interval group)

This group will receive two doses of killed whole cell oral cholera vaccine. The second dose being administered 11 months after the first dose.

Group Type: EXPERIMENTAL

killed whole cell oral cholera vaccine

Intervention Type: BIOLOGICAL

two week interval

Interventions

killed whole cell oral cholera vaccine

two week interval

Intervention Type: BIOLOGICAL

Other Intervention Names

Shanchol

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bill and Melinda Gates Foundation

OTHER

Sponsor Role: collaborator

Meilleur Accès aux Soins de Santé (M.A. Santé)

UNKNOWN

Sponsor Role: collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Sack, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

M.A. Sante

Douala, , Cameroon

Countries

Cameroon

Other Identifiers

8114

Identifier Type: -

Identifier Source: org_study_id