NCT03719066

Extended Dose Intervals With Oral Cholera Vaccine in Cameroon

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 181 (actual)
• Sponsor: Johns Hopkins Bloomberg School of Public Health · Academic / Other
• Sex: All
• Age: 1 Year
• Healthy volunteers: Accepted

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.

Conditions

• Adverse Reaction to Cholera Vaccine
• Cholera Vaccination Reaction

Interventions

Type	Name	Description
BIOLOGICAL	killed whole cell oral cholera vaccine	two week interval

Timeline

• Start date: 2018-10-23
• Primary completion: 2020-02-27
• Completion: 2021-10-05
• First posted: 2018-10-25
• Last updated: 2022-10-05

Locations

1 site across 1 country: Cameroon