NCT03719066|CompletedPhase 2
Extended Dose Intervals With Oral Cholera Vaccine in Cameroon
Effect of Extended Dose Intervals on the Immune Response to Oral Cholera Vaccine in Cameroon
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Effect of Extended Dose Intervals on the Immune Response to Oral Cholera Vaccine in Cameroon
Sponsor study identifier
interventional
181
1 country
1
Study Start
October 23, 2018
Actual (reported)Primary Completion
February 27, 2020
Actual (reported)Study Completion
October 5, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 5, 2021
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 23, 2018
Actual (reported)October 23, 2018
Actual (reported)October 25, 2018
Actual (reported)February 27, 2020
Actual (reported)October 5, 2021
Actual (reported)Vibriocidal titer
Geometric Mean titre of the vibriocidal titre
two weeks after the second dose
ELISA titres
two weeks after the second dose
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.
two week interval
M.A. Sante
Douala, Cameroon
David Sack, MD
Johns Hopkins Bloomberg School of Public Health
181 participants (actual enrollment reported by the registry).
First Submitted
October 23, 2018
First Posted
October 25, 2018
Study Start
October 23, 2018
Actual (reported)Safety and Immunogenicity of Locally Manufactured Oral Cholera Vaccine
This group will receive two doses of killed whole cell oral cholera vaccine. The second dose being administered 11 months after the first dose.
Contact the study team to confirm eligibility.
Primary Completion
February 27, 2020
Actual (reported)Study Completion
October 5, 2021
Actual (reported)Last Updated
October 5, 2022
Record last verified: 2022-10
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.
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Source: ClinicalTrials.gov.
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