Epidemiological Study In Tuberculosis-Endemic Urban Area in Senegal (MTBVAC-EPI)

July 27, 2022 updated by: Gilles Riveau, PharmD, PhD, Biomedical Research Center EPLS

MTBVAC in Newborns: Epidemiological Study In Tuberculosis-Endemic Regions of Sub-Saharan Africa

A cross-sectional childhood M. tuberculosis infection survey of age-specific rates (defined by positivity to the test QuantiFERON-TB Gold Plus) will be conducted in Senegal to collect information on the local TB endemic to inform site selection, sample size, and recruitment strategies for a future efficacy trial of vaccine candidate MTBVAC in young children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

MTBVAC is a new TB vaccine candidate based on an attenuated clinical isolate of M. tuberculosis. The clinical development consortium of this EDCTP program is preparing for future years an MTBVAC efficacy trial by setting up a network of three African sites in South Africa, Senegal and Madagascar. Each site has established an operational clinical research infrastructure. As a first step, Senegal site needs to collect crucial epidemiological data on TB in children, to allow a rapid transition to a phase 3 trial in infants.

The primary objective is to estimate the prevalence of TB infection by the QuantiFERON-TB Gold Plus technique in 500 children splined in 1-year, 2-year, 5-year, and 12-year-old age groups living in the study area (Saint Louis, Senegal).

Secondary objectives are:

  • To study the socio-demographic characteristics, the vaccination history of each subject and the possible tuberculous contacts he has.
  • To map selected populations (from GPS residence data) according to the status (infected or uninfected) of each subject.
  • To ensure the orientation of children found positive by the QuantiFERON-TB Gold Plus test for care and follow-up related to the TB diagnosis and treatment at one of the Health Centers (THC) located in the study areas.
  • To estimate the number of tuberculosis cases detected in children aged up to 12 years and resident in the study area from THC registries and data from the National Tuberculosis Control Plan (PNB).

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint Louis, France, BP226
        • Biomedical Research Center EPLS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 months to 12 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A convenience sample taking into account the constraints related to the QuantiFERON-TB Gold Plus technique was chosen. One hundred and twenty-five (125) children per age group (1 year, 2 years, 5 years and 12 years) will be included. In total, 500 children will be recruited.

Description

Inclusion Criteria:

  • Children resident in the study area (St Louis City)
  • Obtaining written consent from one of the parents / guardians.

  • Children meeting one the following age criterion:

    • 1-year old child (12 months -1/+4 months);
    • 2-year-old child (24 months -1/+4 months);
    • 5-year old child (60 months +/-6 months);
    • 12-year old child (12 years old +/-6 months);

Exclusion Criteria:

  • Child resident outside the study area.
  • Participation refusal by one of the parents / guardians.
  • Objection of the child belonging to the 12-year old group.
  • Child with a known chronic pathology (severe asthma, epilepsy, type 1 diabetes, severe immunosuppression ...)
  • Child considered by the Principal Investigator as medically unfit to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1

Children both genders according to age:

*1-year old children (12 months -1/+4 months); n=125 at the date of recruitment.
Diagnostic test: Quantiferon Gold Plus Test
Small volume of whole blood incubated with specific TB antigen and then dosage of Interferon gamma production.
Group 2

Children both genders according to age:

*2-year-old children (24 months -1/+4 months); n=125 at the date of recruitment.
Diagnostic test: Quantiferon Gold Plus Test
Small volume of whole blood incubated with specific TB antigen and then dosage of Interferon gamma production.
Group 3

Children both genders according to age:

*5-year old children (60 months +/- 6 months); n=125 at the date of recruitment.
Diagnostic test: Quantiferon Gold Plus Test
Small volume of whole blood incubated with specific TB antigen and then dosage of Interferon gamma production.
Group 4

Children both genders according to age:

*12-years old children (12 years old +/- 6 months); n=125 at the date of recruitment.
Diagnostic test: Quantiferon Gold Plus Test
Small volume of whole blood incubated with specific TB antigen and then dosage of Interferon gamma production.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tuberculosis prevalence in children living in urban area in Senegal.
Time Frame: 2 days
To estimate the prevalence of TB infection by QuantiFERON-TB Gold Plus test in children aged 1 year, 2 years, 5 years and 12 years in the city of Saint Louis, Senegal. Blood samples are incubated with TB antigens and then Interferon Gamma production is evaluated by Elisa.
2 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
health survey of the cohort
Time Frame: 2 hours
To carry out a standard questionnaire of the mother of the child included about his vaccinations, the conditions of the child's life and the tuberculous history of his relatives.
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biomedical Research Center EPLS

Collaborators

University of Cape Town
Biofabri, S.L
TuBerculosis Vaccine Initiative
Universidad de Zaragoza
Institut Pasteur de Madagascar

Investigators

  • Principal Investigator: Amadou T LY, Biomedical Research Center EPLS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 27, 2018

Primary Completion (ACTUAL)

December 20, 2020

Study Completion (ACTUAL)

July 27, 2022

Study Registration Dates

First Submitted

December 6, 2018

First Submitted That Met QC Criteria

December 6, 2018

First Posted (ACTUAL)

December 7, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 28, 2022

Last Update Submitted That Met QC Criteria

July 27, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIA2016V-1637

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

A plan to make individual participant data (IPD) collected in this study, including data dictionaries, available to other researchers will be defined in the next semester by partners of the project.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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