Back to results

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

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:

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

Sites / Locations

M.A. Sante

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

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

NCT ID

NCT03719066

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)

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

We'll reach out to this number within 24 hrs