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Extended Dose Intervals With Oral Cholera Vaccine in Cameroon

NCT03719066 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 181

Last updated 2022-10-05

No results posted yet for this study

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

Interventions

BIOLOGICAL

killed whole cell oral cholera vaccine

two week interval

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

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

    collaborator UNKNOWN

  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • David Sack, MD · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-23
Primary Completion
2020-02-27
Completion
2021-10-05

Countries

  • Cameroon

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03719066 on ClinicalTrials.gov