Epidemiological Study In Tuberculosis-Endemic Urban Area in Senegal

Study Overview
=================
Brief Summary
-----------------
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.

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).

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

Conditions
-----------------
Tuberculosis

Intervention / Treatment
-----------------
* Diagnostic Test: Quantiferon Gold Plus Test


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 11 Months
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>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<br>* Small volume of whole blood incubated with specific TB antigen and then dosage of Interferon gamma production.<br>|
| Group 2<br>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<br>* Small volume of whole blood incubated with specific TB antigen and then dosage of Interferon gamma production.<br>|
| Group 3<br>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<br>* Small volume of whole blood incubated with specific TB antigen and then dosage of Interferon gamma production.<br>|
| Group 4<br>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<br>* Small volume of whole blood incubated with specific TB antigen and then dosage of Interferon gamma production.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tuberculosis prevalence in children living in urban area in Senegal. | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MTBVAC, Tuberculosis, Quantiferon Gold Plus test, Tuberculosis in children, SENEGAL