Biomedical Research Center EPLS
Saint-Louis, BP226, France
NCT Number: NCT03767946
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.
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Notify Me11 month–12 year
All sexes
Observational
Saint-Louis, BP226, France
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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Small volume of whole blood incubated with specific TB antigen and then dosage of Interferon gamma production.
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.
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.
Biomedical Research Center EPLS
Other
MTBVAC in Newborns: Epidemiological Study In Tuberculosis-Endemic Regions of Sub-Saharan Africa
Acronym: MTBVAC-EPI
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