Tuberculosis Clinical Trial
— MTBVAC-EPIOfficial title:
MTBVAC in Newborns: Epidemiological Study In Tuberculosis-Endemic Regions of Sub-Saharan Africa
NCT number | NCT03767946 |
Other study ID # | RIA2016V-1637 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 27, 2018 |
Est. completion date | July 27, 2022 |
Verified date | July 2022 |
Source | Biomedical Research Center EPLS |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
France | Biomedical Research Center EPLS | Saint Louis |
Lead Sponsor | Collaborator |
---|---|
Biomedical Research Center EPLS | Biofabri, S.L, Institut Pasteur de Madagascar, TuBerculosis Vaccine Initiative, Universidad de Zaragoza, University of Cape Town |
France,
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
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 |
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