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Completed

NCT Number: NCT03719066

Extended Dose Intervals With 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.

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Key information

Conditions

Adverse Reaction to Cholera Vaccine Bacterial Infections Bacterial Infections and Mycoses Cholera Cholera Vaccination Reaction Gram-Negative Bacterial Infections Infections Vibrio Infections

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

M.A. Sante

Douala, Cameroon

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 -

Exclusion criteria

  • 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

Treatment and study plan

killed whole cell oral cholera vaccine

Biological

two week interval

Other names: Shanchol

Primary outcomes

  1. Vibriocidal titer

    Time frame: two weeks after the second dose

    Geometric Mean titre of the vibriocidal titre

Secondary outcomes

  1. ELISA titres

    Time frame: two weeks after the second dose

    IgG and IgA geometric mean titres against V cholerae LPS

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • Meilleur Accès aux Soins de Santé (M.A. Santé)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Oct 25, 2018
Registry last updated
Oct 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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