TuberculosisMTBVAC-EPINCT03767946
Epidemiological Study In Tuberculosis-Endemic Urban Area in Senegal
An observational study of Tuberculosis, run by Biomedical Research Center EPLS at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 11 months to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Quantiferon Gold Plus Test
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jul 2018to 27 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 months to 12 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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);
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MTBVAC in Newborns: Epidemiological Study In Tuberculosis-Endemic Regions of Sub-Saharan Africa
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.
Read the 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).
- Conditions
- Tuberculosis
- Being tested
- Quantiferon Gold Plus Test
- Keywords
- Tuberculosis, Quantiferon Gold Plus test, Tuberculosis in children, SENEGAL, MTBVAC
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantiferon Gold Plus TestDiagnostic test
Small volume of whole blood incubated with specific TB antigen and then dosage of Interferon gamma production.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Children both genders according to age:
*1-year old children (12 months -1/+4 months); n=125 at the date of recruitment. Receives: 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: Quantiferon Gold Plus Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 days
Secondary outcomes (1)
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.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start27 Jul 2018
- Primary completion20 Dec 2020
- Study completion27 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomedical Research Center EPLS
- Sponsor type
- University, hospital or other
- Collaborators
- Biofabri, S.L, TuBerculosis Vaccine Initiative, Universidad de Zaragoza, University of Cape Town, Institut Pasteur de Madagascar
- Responsible party
- Principal investigator, Gilles Riveau, PharmD, PhD, Biomedical Research Center EPLS
- Investigators
- Amadou T LY, Principal investigator, Biomedical Research Center EPLS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767946
- Sponsor's protocol ID
- RIA2016V-1637
- Acronym
- MTBVAC-EPI
- Status last verified
- Jul 2022
- First submitted
- 6 Dec 2018
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A plan to make individual participant data (IPD) collected in this study, including data dictionaries, available to other researchers will be defined in the next semester by partners of the project.
Publications
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.
PubMed 23965219Marinova 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.
PubMed 28447476Cuevas 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.
PubMed 22476719Nemes 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.
PubMed 28737960
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MTBVAC in Newborns: Epidemiological Study In Tuberculosis-Endemic Regions of Sub-Saharan Africa
- ClinicalTrials.gov ID
- NCT03767946
- Acronym / sponsor ID
- MTBVAC-EPI / RIA2016V-1637
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis, Quantiferon Gold Plus test, Tuberculosis in children, SENEGAL, MTBVAC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Biomedical Research Center EPLSUniversity, hospital or other
- Collaborators
- Biofabri, S.L, TuBerculosis Vaccine Initiative, Universidad de Zaragoza, University of Cape Town, Institut Pasteur de Madagascar
- Study start
- 27 Jul 2018 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 27 Jul 2022 (actual)
- First posted
- 7 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: Quantiferon Gold Plus TestChildren both genders according to age: *1-year old children (12 months -1/+4 months); n=125 at the date of recruitment. |
| Group 2 | – | Diagnostic Test: Quantiferon Gold Plus TestChildren both genders according to age: *2-year-old children (24 months -1/+4 months); n=125 at the date of recruitment. |
| Group 3 | – | Diagnostic Test: Quantiferon Gold Plus TestChildren both genders according to age: *5-year old children (60 months +/- 6 months); n=125 at the date of recruitment. |
| Group 4 | – | Diagnostic Test: Quantiferon Gold Plus TestChildren both genders according to age: *12-years old children (12 years old +/- 6 months); n=125 at the date of recruitment. |
Who may qualify
- Ages
- 11 months to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantiferon Gold Plus TestSmall volume of whole blood incubated with specific TB antigen and then dosage of Interferon gamma production. | Diagnostic test | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Tuberculosis prevalence in children living in urban area in Senegal.
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.
1 secondary outcome
health survey of the cohort
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Background: PubMed 23965219Arbues 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.
- Background: PubMed 28447476Marinova 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.
- Background: PubMed 22476719Cuevas 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.
- Results publication: PubMed 28737960Nemes 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.
- Individual participant dataSharing planned: Undecided. A plan to make individual participant data (IPD) collected in this study, including data dictionaries, available to other researchers will be defined in the next semester by partners of the project.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amadou T LY principal investigator
Biomedical Research Center EPLS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by Biomedical Research Center EPLS at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tuberculosis prevalence in children living in urban area in Senegal. (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03767946, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022.