<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03767946</url>
  </required_header>
  <id_info>
    <org_study_id>RIA2016V-1637</org_study_id>
    <nct_id>NCT03767946</nct_id>
  </id_info>
  <brief_title>Epidemiological Study In Tuberculosis-Endemic Urban Area in Senegal</brief_title>
  <acronym>MTBVAC-EPI</acronym>
  <official_title>MTBVAC in Newborns: Epidemiological Study In Tuberculosis-Endemic Regions of Sub-Saharan Africa</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Biomedical Research Center EPLS</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Biofabri, S.L</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>TuBerculosis Vaccine Initiative</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universidad de Zaragoza</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Cape Town</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institut Pasteur de Madagascar</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Biomedical Research Center EPLS</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A cross-sectional childhood M. tuberculosis infection survey of age-specific rates (defined&#xD;
      by positivity to the test QuantiFERON-TB Gold Plus) will be conducted in Senegal to collect&#xD;
      information on the local TB endemic to inform site selection, sample size, and recruitment&#xD;
      strategies for a future efficacy trial of vaccine candidate MTBVAC in young children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      MTBVAC is a new TB vaccine candidate based on an attenuated clinical isolate of M.&#xD;
      tuberculosis. The clinical development consortium of this EDCTP program is preparing for&#xD;
      future years an MTBVAC efficacy trial by setting up a network of three African sites in South&#xD;
      Africa, Senegal and Madagascar. Each site has established an operational clinical research&#xD;
      infrastructure. As a first step, Senegal site needs to collect crucial epidemiological data&#xD;
      on TB in children, to allow a rapid transition to a phase 3 trial in infants.&#xD;
&#xD;
      The primary objective is to estimate the prevalence of TB infection by the QuantiFERON-TB&#xD;
      Gold Plus technique in 500 children splined in 1-year, 2-year, 5-year, and 12-year-old age&#xD;
      groups living in the study area (Saint Louis, Senegal).&#xD;
&#xD;
      Secondary objectives are:&#xD;
&#xD;
        -  To study the socio-demographic characteristics, the vaccination history of each subject&#xD;
           and the possible tuberculous contacts he has.&#xD;
&#xD;
        -  To map selected populations (from GPS residence data) according to the status (infected&#xD;
           or uninfected) of each subject.&#xD;
&#xD;
        -  To ensure the orientation of children found positive by the QuantiFERON-TB Gold Plus&#xD;
           test for care and follow-up related to the TB diagnosis and treatment at one of the&#xD;
           Health Centers (THC) located in the study areas.&#xD;
&#xD;
        -  To estimate the number of tuberculosis cases detected in children aged up to 12 years&#xD;
           and resident in the study area from THC registries and data from the National&#xD;
           Tuberculosis Control Plan (PNB).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 27, 2018</start_date>
  <completion_date type="Actual">July 27, 2022</completion_date>
  <primary_completion_date type="Actual">December 20, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Tuberculosis prevalence in children living in urban area in Senegal.</measure>
    <time_frame>2 days</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>health survey of the cohort</measure>
    <time_frame>2 hours</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">500</enrollment>
  <condition>Tuberculosis</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>Children both genders according to age:&#xD;
*1-year old children (12 months -1/+4 months); n=125 at the date of recruitment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>Children both genders according to age:&#xD;
*2-year-old children (24 months -1/+4 months); n=125 at the date of recruitment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <description>Children both genders according to age:&#xD;
*5-year old children (60 months +/- 6 months); n=125 at the date of recruitment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 4</arm_group_label>
    <description>Children both genders according to age:&#xD;
*12-years old children (12 years old +/- 6 months); n=125 at the date of recruitment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Quantiferon Gold Plus Test</intervention_name>
    <description>Small volume of whole blood incubated with specific TB antigen and then dosage of Interferon gamma production.</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_label>Group 4</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood sample for Quantiferon Gold Plus assay&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        A convenience sample taking into account the constraints related to the QuantiFERON-TB Gold&#xD;
        Plus technique was chosen. One hundred and twenty-five (125) children per age group (1&#xD;
        year, 2 years, 5 years and 12 years) will be included. In total, 500 children will be&#xD;
        recruited.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children resident in the study area (St Louis City)&#xD;
&#xD;
          -  Obtaining written consent from one of the parents / guardians.&#xD;
&#xD;
          -  Children meeting one the following age criterion:&#xD;
&#xD;
               -  1-year old child (12 months -1/+4 months);&#xD;
&#xD;
               -  2-year-old child (24 months -1/+4 months);&#xD;
&#xD;
               -  5-year old child (60 months +/-6 months);&#xD;
&#xD;
               -  12-year old child (12 years old +/-6 months);&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Child resident outside the study area.&#xD;
&#xD;
          -  Participation refusal by one of the parents / guardians.&#xD;
&#xD;
          -  Objection of the child belonging to the 12-year old group.&#xD;
&#xD;
          -  Child with a known chronic pathology (severe asthma, epilepsy, type 1 diabetes, severe&#xD;
             immunosuppression ...)&#xD;
&#xD;
          -  Child considered by the Principal Investigator as medically unfit to participate in&#xD;
             the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Months</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amadou T LY</last_name>
    <role>Principal Investigator</role>
    <affiliation>Biomedical Research Center EPLS</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Biomedical Research Center EPLS</name>
      <address>
        <city>Saint Louis</city>
        <zip>BP226</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>23965219</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>28447476</PMID>
  </reference>
  <reference>
    <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(Suppl 2):S209-15. doi: 10.1093/infdis/jir879. Epub 2012 Apr 3.</citation>
    <PMID>22476719</PMID>
  </reference>
  <results_reference>
    <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, 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.</citation>
    <PMID>28737960</PMID>
  </results_reference>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>July 27, 2022</last_update_submitted>
  <last_update_submitted_qc>July 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Biomedical Research Center EPLS</investigator_affiliation>
    <investigator_full_name>Gilles Riveau, PharmD, PhD</investigator_full_name>
    <investigator_title>CEO</investigator_title>
  </responsible_party>
  <keyword>Tuberculosis</keyword>
  <keyword>Quantiferon Gold Plus test</keyword>
  <keyword>Tuberculosis in children</keyword>
  <keyword>SENEGAL</keyword>
  <keyword>MTBVAC</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberculosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>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.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03767946
org study id: RIA2016V-1637
nct id: NCT03767946
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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).
observational model: Cohort
time perspective: Prospective
measure: Tuberculosis prevalence in children living in urban area in Senegal.
time frame: 2 days
description: 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.
measure: health survey of the cohort
time frame: 2 hours
description: 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.
arm group label: Group 1
description: Children both genders according to age:
*1-year old children (12 months -1/+4 months); n=125 at the date of recruitment.
arm group label: Group 2
description: Children both genders according to age:
*2-year-old children (24 months -1/+4 months); n=125 at the date of recruitment.
arm group label: Group 3
description: Children both genders according to age:
*5-year old children (60 months +/- 6 months); n=125 at the date of recruitment.
arm group label: Group 4
description: Children both genders according to age:
*12-years old children (12 years old +/- 6 months); n=125 at the date of recruitment.
intervention type: Diagnostic Test
intervention name: Quantiferon Gold Plus Test
description: Small volume of whole blood incubated with specific TB antigen and then dosage of Interferon gamma production.
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
arm group label: Group 4
Blood sample for Quantiferon Gold Plus assay
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 11 Months
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Amadou T LY
role: Principal Investigator
affiliation: Biomedical Research Center EPLS
facility: 
country: France
citation: 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: 23965219
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.
PMID: 28447476
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(Suppl 2):S209-15. doi: 10.1093/infdis/jir879. Epub 2012 Apr 3.
PMID: 22476719
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, 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: 28737960
responsible party type: Principal Investigator
investigator affiliation: Biomedical Research Center EPLS
investigator full name: Gilles Riveau, PharmD, PhD
investigator title: CEO
mesh term: Tuberculosis
sharing ipd: Undecided
ipd description: 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.