Epidemiological Study In Tuberculosis-Endemic Urban Area in Senegal

Tuberculosis Clinical Trial

— MTBVAC-EPI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03767946
• Other study ID #: RIA2016V-1637
• Status: Completed
• Start date: July 27, 2018
• Est. completion date: July 27, 2022

Study information

• Verified date: July 2022
• Source: Biomedical Research Center EPLS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: July 27, 2022
• Est. primary completion date: December 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Months to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Diagnostic Test:
• Quantiferon Gold Plus Test
Small volume of whole blood incubated with specific TB antigen and then dosage of Interferon gamma production.

Locations

Country	Name	City	State
France	Biomedical Research Center EPLS	Saint Louis

Sponsors (6)

Lead Sponsor	Collaborator
Biomedical Research Center EPLS	Biofabri, S.L, Institut Pasteur de Madagascar, TuBerculosis Vaccine Initiative, Universidad de Zaragoza, University of Cape Town

Country where clinical trial is conducted

France, 

References & Publications (4)

Arbues A, Aguilo JI, Gonzalo-Asensio J, Marinova D, Uranga S, Puentes E, Fernandez C, Parra A, Cardona PJ, Vilaplana C, Ausina V, Williams A, Clark S, Malaga W, Guilhot C, Gicquel B, Martin C. Construction, characterization and preclinical evaluation of MTBVAC, the first live-attenuated M. tuberculosis-based vaccine to enter clinical trials. Vaccine. 2013 Oct 1;31(42):4867-73. doi: 10.1016/j.vaccine.2013.07.051. Epub 2013 Aug 17. — View Citation

Cuevas LE, Browning R, Bossuyt P, Casenghi M, Cotton MF, Cruz AT, Dodd LE, Drobniewski F, Gale M, Graham SM, Grzemska M, Heinrich N, Hesseling AC, Huebner R, Jean-Philippe P, Kabra SK, Kampmann B, Lewinsohn D, Li M, Lienhardt C, Mandalakas AM, Marais BJ, Menzies HJ, Montepiedra G, Mwansambo C, Oberhelman R, Palumbo P, Russek-Cohen E, Shapiro DE, Smith B, Soto-Castellares G, Starke JR, Swaminathan S, Wingfield C, Worrell C. Evaluation of tuberculosis diagnostics in children: 2. Methodological issues for conducting and reporting research evaluations of tuberculosis diagnostics for intrathoracic tuberculosis in children. Consensus from an expert panel. J Infect Dis. 2012 May 15;205 Suppl 2:S209-15. doi: 10.1093/infdis/jir879. Epub 2012 Apr 3. — View Citation

Marinova D, Gonzalo-Asensio J, Aguilo N, Martin C. MTBVAC from discovery to clinical trials in tuberculosis-endemic countries. Expert Rev Vaccines. 2017 Jun;16(6):565-576. doi: 10.1080/14760584.2017.1324303. Epub 2017 May 12. Review. — View Citation

Nemes E, Rozot V, Geldenhuys H, Bilek N, Mabwe S, Abrahams D, Makhethe L, Erasmus M, Keyser A, Toefy A, Cloete Y, Ratangee F, Blauenfeldt T, Ruhwald M, Walzl G, Smith B, Loxton AG, Hanekom WA, Andrews JR, Lempicki MD, Ellis R, Ginsberg AM, Hatherill M, Sc — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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