Extended Dose Intervals With Oral Cholera Vaccine in Cameroon

Effect of Extended Dose Intervals on the Immune Response to Oral Cholera Vaccine in Cameroon

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.

Study Overview

• Status: Completed
• Conditions: Cholera Vaccination Reaction; Adverse Reaction to Cholera Vaccine
• Intervention / Treatment: Biological: killed whole cell oral cholera vaccine

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.

• Study Type: Interventional
• Enrollment (Actual): 181
• Phase: Phase 2

Contacts and Locations

Study Locations

• Cameroon
  • Douala, Cameroon
    • M.A. Sante

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	Biological: killed whole cell oral cholera vaccine; two week interval; Other Names: Shanchol
EXPERIMENTAL: 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.	Biological: killed whole cell oral cholera vaccine; two week interval; Other Names: Shanchol
EXPERIMENTAL: 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.	Biological: killed whole cell oral cholera vaccine; two week interval; Other Names: Shanchol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vibriocidal titer	Geometric Mean titre of the vibriocidal titre	two weeks after the second dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ELISA titres	IgG and IgA geometric mean titres against V cholerae LPS	two weeks after the second dose

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: Bill and Melinda Gates Foundation; Meilleur Accès aux Soins de Santé (M.A. Santé)
• Investigators: Principal Investigator: David Sack, MD, Johns Hopkins Bloomberg School of Public Health

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 23, 2018
• Primary Completion (ACTUAL): February 27, 2020
• Study Completion (ACTUAL): October 5, 2021

Study Registration Dates

• First Submitted: October 23, 2018
• First Submitted That Met QC Criteria: October 23, 2018
• First Posted (ACTUAL): October 25, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 5, 2022
• Last Update Submitted That Met QC Criteria: October 4, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: cholera; oral cholera vaccine; vibriocidal titer; ELISA antibodies; Adverse event following immunization
• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Vibrio Infections; Cholera
• Other Study ID Numbers: 8114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No