Extended Dose Intervals With Oral Cholera Vaccine in Cameroon

NCT03719066 | Completed Phase 2

• 1 other identifier: 8114
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 1

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.

Conditions

Adverse Reaction to Cholera Vaccine; Cholera Vaccination Reaction

Keywords

cholera; oral cholera vaccine; vibriocidal titer; ELISA antibodies; Adverse event following immunization

Outcome Measures

Primary Outcomes (1)

• Vibriocidal titer

  Geometric Mean titre of the vibriocidal titre

  two weeks after the second dose

Secondary Outcomes (1)

• ELISA titres

  two weeks after the second dose

Study Arms (3)

DIG 1 (dose interval group)

ACTIVE COMPARATOR

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

DIG 2 (dose interval group)

EXPERIMENTAL

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

DIG 3 (dose interval group)

EXPERIMENTAL

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

Interventions

killed whole cell oral cholera vaccine BIOLOGICAL

two week interval

Also known as: Shanchol

DIG 1 (dose interval group); DIG 2 (dose interval group); DIG 3 (dose interval group)

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Bill and Melinda Gates Foundation: collaborator
• Meilleur Accès aux Soins de Santé (M.A. Santé): collaborator

Study Sites (1)

M.A. Sante

Douala, Cameroon

Location

MeSH Terms

Conditions

Cholera

Interventions

shanchol

Condition Hierarchy (Ancestors)

Vibrio Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• David Sack, MD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: October 25, 2018
• Study Start: October 23, 2018
• Primary Completion: February 27, 2020
• Study Completion: October 5, 2021
• Last Updated: October 5, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: When the manuscript is published.
• Access Criteria: Researchers will need to submit a request to the investigators detailing their plans for analysis.

Locations

CA (1)