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Extended Dose Intervals With Oral Cholera Vaccine in Cameroon

Primary Purpose

Adverse Reaction to Cholera Vaccine, Cholera Vaccination Reaction

Status
Completed
Phase
Phase 2
Locations
Cameroon
Study Type
Interventional
Intervention
killed whole cell oral cholera vaccine
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

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

1 Year - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • M.A. Sante

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

DIG 1 (dose interval group)

DIG 2 (dose interval group)

DIG 3 (dose interval group)

Arm Description

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.

Outcomes

Primary Outcome Measures

Vibriocidal titer
Geometric Mean titre of the vibriocidal titre

Secondary Outcome Measures

ELISA titres
IgG and IgA geometric mean titres against V cholerae LPS

Full Information

First Posted
October 23, 2018
Last Updated
October 4, 2022
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Bill and Melinda Gates Foundation, Meilleur Accès aux Soins de Santé (M.A. Santé)
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1. Study Identification

Unique Protocol Identification Number
NCT03719066
Brief Title
Extended Dose Intervals With Oral Cholera Vaccine in Cameroon
Official Title
Effect of Extended Dose Intervals on the Immune Response to Oral Cholera Vaccine in Cameroon
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
October 23, 2018 (Actual)
Primary Completion Date
February 27, 2020 (Actual)
Study Completion Date
October 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Bill and Melinda Gates Foundation, Meilleur Accès aux Soins de Santé (M.A. Santé)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adverse Reaction to Cholera Vaccine, Cholera Vaccination Reaction
Keywords
cholera, oral cholera vaccine, vibriocidal titer, ELISA antibodies, Adverse event following immunization

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
181 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DIG 1 (dose interval group)
Arm Type
Active Comparator
Arm Description
This group will receive two doses of killed whole cell oral cholera vaccine. The second dose being administered two weeks after the first dose.
Arm Title
DIG 2 (dose interval group)
Arm Type
Experimental
Arm Description
This group will receive two doses of killed whole cell oral cholera vaccine. The second dose being administered 6 months after the first dose.
Arm Title
DIG 3 (dose interval group)
Arm Type
Experimental
Arm Description
This group will receive two doses of killed whole cell oral cholera vaccine. The second dose being administered 11 months after the first dose.
Intervention Type
Biological
Intervention Name(s)
killed whole cell oral cholera vaccine
Other Intervention Name(s)
Shanchol
Intervention Description
two week interval
Primary Outcome Measure Information:
Title
Vibriocidal titer
Description
Geometric Mean titre of the vibriocidal titre
Time Frame
two weeks after the second dose
Secondary Outcome Measure Information:
Title
ELISA titres
Description
IgG and IgA geometric mean titres against V cholerae LPS
Time Frame
two weeks after the second dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Sack, MD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
M.A. Sante
City
Douala
Country
Cameroon

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We will publish the results of this study in a peer reviewed publication and will make the data available on request after the paper has been published.
IPD Sharing Time Frame
When the manuscript is published.
IPD Sharing Access Criteria
Researchers will need to submit a request to the investigators detailing their plans for analysis.

Learn more about this trial

Extended Dose Intervals With Oral Cholera Vaccine in Cameroon

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