NCT03767946

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 27, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2020

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2022

Completed
Last Updated

July 28, 2022

Status Verified

July 1, 2022

Enrollment Period

2.4 years

First QC Date

December 6, 2018

Last Update Submit

July 27, 2022

Conditions

Tuberculosis

Keywords

TuberculosisQuantiferon Gold Plus testTuberculosis in childrenSENEGALMTBVAC

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • health survey of the cohort

    2 hours

Study Arms (4)

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

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

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

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

Interventions

Quantiferon Gold Plus TestDIAGNOSTIC_TEST

Small volume of whole blood incubated with specific TB antigen and then dosage of Interferon gamma production.

Group 1Group 2Group 3Group 4

Eligibility Criteria

Age11 Months - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biomedical Research Center EPLS

Saint-Louis, BP226, France

Location

Related 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.

    PMID: 23965219BACKGROUND

  • 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.

    PMID: 28447476BACKGROUND

  • 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(Suppl 2):S209-15. doi: 10.1093/infdis/jir879. Epub 2012 Apr 3.

    PMID: 22476719BACKGROUND

  • 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, Scriba TJ; C-040-404 Study Team and the Adolescent Cohort Study Team. Optimization and Interpretation of Serial QuantiFERON Testing to Measure Acquisition of Mycobacterium tuberculosis Infection. Am J Respir Crit Care Med. 2017 Sep 1;196(5):638-648. doi: 10.1164/rccm.201704-0817OC.

    PMID: 28737960RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample for Quantiferon Gold Plus assay

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Amadou T LY

    Biomedical Research Center EPLS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
CEO

Study Record Dates

First Submitted

December 6, 2018

First Posted

December 7, 2018

Study Start

July 27, 2018

Primary Completion

December 20, 2020

Study Completion

July 27, 2022

Last Updated

July 28, 2022

Record last verified: 2022-07

Locations

FR(1)