<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/NCT03027154</url>
  </required_header>
  <id_info>
    <org_study_id>LTao-EC III-children</org_study_id>
    <nct_id>NCT03027154</nct_id>
  </id_info>
  <brief_title>Clinical Study of Recombinant Mycobacterium Tuberculosis ESAT6-CFP10 Allergen for Children</brief_title>
  <official_title>For Tuberculosis (TB) Clinical Auxiliary Diagnosis of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 Dose Certain Phase III Clinical Research in Children Under the Age of 18 Years Old</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shanghai Public Health Clinical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wuhan Institute for Tuberculosis Control</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wuhan Union Hospital, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this clinical research,48 cases TB (Tuberculosis patients) participants and 48 cases&#xD;
      non-TB participants with lung disease who all meet the standard are divided into different&#xD;
      groups through a randomized and blind method. Every subject inject intradermally ESAT6-CFP10&#xD;
      and TB-PPD (tuberculin purified protein derivative) in different arms of the same person by&#xD;
      blind method. Specific gama-interferon (γ-IFN) detection is needed before the&#xD;
      injection.Measure the induration and (or) redness of longitudinal diameter size and&#xD;
      transverse diameter vernier caliper by vernier caliper after injection 24h, 48h and 72h. At&#xD;
      the same time, we observe all kind of adverse events in order to assess the safety of drug.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this clinical research,we make sure of the safety in the crowd 5-18 years old firstly,then&#xD;
      carry out the crowd of under 5 years old(including 5).&#xD;
&#xD;
      Firstly, 24 cases TB (Tuberculosis) participants and 24 cases non-TB participants with lung&#xD;
      disease who are all 5-18 years old and meet the standard respectively are divided into&#xD;
      different groups through a randomized and blind method.&#xD;
&#xD;
        1. ESAT6-CFP10(10ug/ml) in left arm and TB-PPD in right arm&#xD;
&#xD;
        2. ESAT6-CFP10(10ug/ml) in right arm and TB-PPD in left arm Inject intradermally&#xD;
           ESAT6-CFP10 and TB-PPD in different arms of the same participant. For each of&#xD;
           participant, the person in this clinical research, the study uniform is that every&#xD;
           subject injects firstly left arm, observe no obvious adverse reaction, then another drug&#xD;
           inject in right arm. Measure the induration and (or) redness of longitudinal diameter&#xD;
           size and transverse diameter vernier caliper by vernier caliper after injection 24h, 48h&#xD;
           and 72h. At the same time, we observe the vital signs (breathing, heart rate, blood&#xD;
           pressure and temperature), local reactions (rash, pain, itching and skin mucous&#xD;
           membrane) and a variety of adverse events.&#xD;
&#xD;
      Secondly, 24 cases TB (Tuberculosis) participants and 24 cases non-TB participants with lung&#xD;
      disease who are all less than 5 years old are divided into two different groups and the&#xD;
      procedure are as the same as 5-18 years old.&#xD;
&#xD;
      Finally, we calculate the sensitivity (positive coincidence rate) by TB (Tuberculosis&#xD;
      patients), the specificity (negative coincidence rate) by non-TB participants with lung&#xD;
      disease, and verify the safety and effectiveness of ESAT6-CFP10(10ug/ml) for the clinical&#xD;
      auxiliary diagnosis of tuberculosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">March 2018</completion_date>
  <primary_completion_date type="Actual">October 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The diameter of induration or redness at the injection sites measured transversely to the long axis of the forearm 24 hours、48 hours and 72 hours after application of the agents</measure>
    <time_frame>From injections to 1-3 days after aplication</time_frame>
    <description>After skin test 1-3d,subjects's injection site may appear inuration or redness .The diameters of induration or redness are measured and recorded.The number of diameter of induration or redness&lt;5mm，the result is negtive.If the number of diameter are not lower than 5mm,the result is positive.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with Adverse Events</measure>
    <time_frame>within 72h after injection two drug each participant</time_frame>
    <description>Any AE of every subject appeared is recorded and traced after signing ICF,until remission of AE.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">96</enrollment>
  <condition>Tuberculosis Diagnosis</condition>
  <arm_group>
    <arm_group_label>TB subjects in 5-18 years old</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>24 cases TB subjects in 5-18 years old are injected ESAT6-CFP10 in left arm and TB-PPD in right arm or ESAT6-CFP10 in right arm and TB-PPD in left arm. For each of participant,the person in this clinical research, the study uniform is that every subject injects firstly left arm, observe no obvious adverse reaction, then another drug inject in right arm. Measure the induration and (or) redness of longitudinal diameter size and transverse diameter vernier caliper by vernier caliper after injection 24h, 48h and 72h.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-TB subjects in 5-18 years old</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>24 cases non-TB subjects in 5-18 years old are injected ESAT6-CFP10 in left arm and TB-PPD in right arm or ESAT6-CFP10 in right arm and TB-PPD in left arm. For each of participant,the person in this clinical research, the study uniform is that every subject injects firstly left arm, observe no obvious adverse reaction, then another drug inject in right arm. Measure the induration and (or) redness of longitudinal diameter size and transverse diameter vernier caliper by vernier caliper after injection 24h, 48h and 72h.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TB subjects under 5 years old</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>24 cases TB subjects under 5 years old are injected ESAT6-CFP10 in left arm and TB-PPD in right arm or ESAT6-CFP10 in right arm and TB-PPD in left arm. For each of participant,the person in this clinical research, the study uniform is that every subject injects firstly left arm, observe no obvious adverse reaction, then another drug inject in right arm. Measure the induration and (or) redness of longitudinal diameter size and transverse diameter vernier caliper by vernier caliper after injection 24h, 48h and 72h.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-TB subjects under 5 years old</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>24 cases non-TB subjects under 5 years old are injected ESAT6-CFP10 in left arm and TB-PPD in right arm or ESAT6-CFP10 in right arm and TB-PPD in left arm. For each of participant,the person in this clinical research, the study uniform is that every subject injects firstly left arm, observe no obvious adverse reaction, then another drug inject in right arm. Measure the induration and (or) redness of longitudinal diameter size and transverse diameter vernier caliper by vernier caliper after injection 24h, 48h and 72h.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ESAT6-CFP10 in left arm and TB-PPD in right arm</intervention_name>
    <description>All subjects including TB subjects in 5-18 years old、non-TB subjects in 5-18 years old、TB subjects under 5 years old and non-TB subjects under 5 years old inject ESAT6-CFP10 in left arm and TB-PPD in right arm respectively. Two drug must use at the same participant and in different arms.</description>
    <arm_group_label>TB subjects in 5-18 years old</arm_group_label>
    <arm_group_label>TB subjects under 5 years old</arm_group_label>
    <arm_group_label>non-TB subjects in 5-18 years old</arm_group_label>
    <arm_group_label>non-TB subjects under 5 years old</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ESAT6-CFP10 in right arm and TB-PPD in left arm</intervention_name>
    <description>All subjects including TB subjects in 5-18 years old、non-TB subjects in 5-18 years old、TB subjects under 5 years old and non-TB subjects under 5 years old inject ESAT6-CFP10 in right arm and TB-PPD in left arm respectively. Two drug must use at the same participant and in different arms.</description>
    <arm_group_label>TB subjects in 5-18 years old</arm_group_label>
    <arm_group_label>TB subjects under 5 years old</arm_group_label>
    <arm_group_label>non-TB subjects in 5-18 years old</arm_group_label>
    <arm_group_label>non-TB subjects under 5 years old</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria of TB (tuberculosis:include pulmonary tuberculosis and extra pulmonary&#xD;
        tuberculosis) subjects:&#xD;
&#xD;
          -  judge the pulmonary tuberculosis patient ,according to Chinese Medical Association&#xD;
             branch of pediatrics breathing group: Tuberculosis Clinical Diagnostic Criteria and&#xD;
             Treatment Programs for Child (trial) ;&#xD;
&#xD;
          -  less than 18 years old ,no gender limited;&#xD;
&#xD;
          -  Consent and signed informed consent forms (ICF) by the subject or the guardian;&#xD;
&#xD;
          -  The subject or with the help of guardian(s) comply with follow-up.&#xD;
&#xD;
        Inclusion Criteria of extra pulmonary tuberculosis subjects:&#xD;
&#xD;
          -  Diagnosed extra pulmonary tuberculosis by epidemiology, imaging, clinical symptoms,&#xD;
             pathological examination and so on;&#xD;
&#xD;
          -  Lesions outside the lungs;&#xD;
&#xD;
          -  be in unfinished reinforced phase by chemotherapy;&#xD;
&#xD;
        Exclusion Criteria of TB (tuberculosis) subjects:&#xD;
&#xD;
          -  Accompanied by the following severe illness: cancer, acute/progressive liver disease&#xD;
             or kidney disease,autoimmune disease，diabetes, primary immunodeficiency diseases,&#xD;
             other chronic diseases;&#xD;
&#xD;
          -  Taking part in other clinical or within three months involved in any other clinical;&#xD;
&#xD;
          -  Severe allergic constitution or familial history of allergy:allergic to two or more&#xD;
             drugs;&#xD;
&#xD;
          -  in pregnancy or lactation;&#xD;
&#xD;
          -  in a mental illness;&#xD;
&#xD;
          -  Any conditions affect the trial evaluation by investigator's judgement.&#xD;
&#xD;
        Inclusion Criteria of non-TB participants with lung disease:&#xD;
&#xD;
          -  A clear respiratory disease but can exclude pulmonary tuberculosis by clinical&#xD;
             symptoms, imaging, laboratory examination.&#xD;
&#xD;
          -  less than 18 years old ,no gender limited;&#xD;
&#xD;
          -  Consent and signed informed consent forms (ICF) by the subject or the guardian;&#xD;
&#xD;
          -  The subject or with the help of guardian(s) comply with follow-up.&#xD;
&#xD;
        Exclusion Criteria of non-TB participants with lung disease:&#xD;
&#xD;
          -  Accompanied by the following severe illness: cancer, acute/progressive liver disease&#xD;
             or kidney disease,autoimmune disease，diabetes, primary immunodeficiency diseases,&#xD;
             other chronic diseases， ect;&#xD;
&#xD;
          -  Taking part in other clinical or within three months involved in any other clinical;&#xD;
&#xD;
          -  Severe allergic constitution or familial history of allergy: allergic to two or more&#xD;
             drugs;&#xD;
&#xD;
          -  in pregnancy or lactation;&#xD;
&#xD;
          -  in a mental illness;&#xD;
&#xD;
          -  active tuberculosis close contactor;&#xD;
&#xD;
          -  Any conditions affect the trial evaluation by investigator's judgement.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shuihua Lu, BBachelor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Public Health Clinical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wuhan Medical Treatment Center</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Children's Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Public Health Clinical Center</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wuhan Institute for Tuberculosis Control</name>
      <address>
        <city>Wuhan</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>van Pinxteren LA, Ravn P, Agger EM, Pollock J, Andersen P. Diagnosis of tuberculosis based on the two specific antigens ESAT-6 and CFP10. Clin Diagn Lab Immunol. 2000 Mar;7(2):155-60. doi: 10.1128/CDLI.7.2.155-160.2000.</citation>
    <PMID>10702486</PMID>
  </reference>
  <reference>
    <citation>Brusasca PN, Colangeli R, Lyashchenko KP, Zhao X, Vogelstein M, Spencer JS, McMurray DN, Gennaro ML. Immunological characterization of antigens encoded by the RD1 region of the Mycobacterium tuberculosis genome. Scand J Immunol. 2001 Nov;54(5):448-52. doi: 10.1046/j.1365-3083.2001.00975.x.</citation>
    <PMID>11696195</PMID>
  </reference>
  <reference>
    <citation>Weldingh K, Andersen P. ESAT-6/CFP10 skin test predicts disease in M. tuberculosis-infected guinea pigs. PLoS One. 2008 Apr 23;3(4):e1978. doi: 10.1371/journal.pone.0001978.</citation>
    <PMID>18431468</PMID>
  </reference>
  <reference>
    <citation>Aagaard C, Govaerts M, Meikle V, Vallecillo AJ, Gutierrez-Pabello JA, Suarez-Guemes F, McNair J, Cataldi A, Espitia C, Andersen P, Pollock JM. Optimizing antigen cocktails for detection of Mycobacterium bovis in herds with different prevalences of bovine tuberculosis: ESAT6-CFP10 mixture shows optimal sensitivity and specificity. J Clin Microbiol. 2006 Dec;44(12):4326-35. doi: 10.1128/JCM.01184-06. Epub 2006 Sep 27.</citation>
    <PMID>17005738</PMID>
  </reference>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>April 10, 2018</last_update_submitted>
  <last_update_submitted_qc>April 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>diagnostic test</keyword>
  <keyword>children</keyword>
  <keyword>diagnosis of tuberculosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberculosis</mesh_term>
    <mesh_term>Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03027154
org study id: LTao-EC III-children
nct id: NCT03027154
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
In this clinical research,48 cases TB (Tuberculosis patients) participants and 48 cases
      non-TB participants with lung disease who all meet the standard are divided into different
      groups through a randomized and blind method. Every subject inject intradermally ESAT6-CFP10
      and TB-PPD (tuberculin purified protein derivative) in different arms of the same person by
      blind method. Specific gama-interferon (γ-IFN) detection is needed before the
      injection.Measure the induration and (or) redness of longitudinal diameter size and
      transverse diameter vernier caliper by vernier caliper after injection 24h, 48h and 72h. At
      the same time, we observe all kind of adverse events in order to assess the safety of drug.
In this clinical research,we make sure of the safety in the crowd 5-18 years old firstly,then
      carry out the crowd of under 5 years old(including 5).

      Firstly, 24 cases TB (Tuberculosis) participants and 24 cases non-TB participants with lung
      disease who are all 5-18 years old and meet the standard respectively are divided into
      different groups through a randomized and blind method.

        1. ESAT6-CFP10(10ug/ml) in left arm and TB-PPD in right arm

        2. ESAT6-CFP10(10ug/ml) in right arm and TB-PPD in left arm Inject intradermally
           ESAT6-CFP10 and TB-PPD in different arms of the same participant. For each of
           participant, the person in this clinical research, the study uniform is that every
           subject injects firstly left arm, observe no obvious adverse reaction, then another drug
           inject in right arm. Measure the induration and (or) redness of longitudinal diameter
           size and transverse diameter vernier caliper by vernier caliper after injection 24h, 48h
           and 72h. At the same time, we observe the vital signs (breathing, heart rate, blood
           pressure and temperature), local reactions (rash, pain, itching and skin mucous
           membrane) and a variety of adverse events.

      Secondly, 24 cases TB (Tuberculosis) participants and 24 cases non-TB participants with lung
      disease who are all less than 5 years old are divided into two different groups and the
      procedure are as the same as 5-18 years old.

      Finally, we calculate the sensitivity (positive coincidence rate) by TB (Tuberculosis
      patients), the specificity (negative coincidence rate) by non-TB participants with lung
      disease, and verify the safety and effectiveness of ESAT6-CFP10(10ug/ml) for the clinical
      auxiliary diagnosis of tuberculosis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Double (Participant, Investigator)
measure: The diameter of induration or redness at the injection sites measured transversely to the long axis of the forearm 24 hours、48 hours and 72 hours after application of the agents
time frame: From injections to 1-3 days after aplication
description: After skin test 1-3d,subjects's injection site may appear inuration or redness .The diameters of induration or redness are measured and recorded.The number of diameter of induration or redness<5mm，the result is negtive.If the number of diameter are not lower than 5mm,the result is positive.
measure: Number of participants with Adverse Events
time frame: within 72h after injection two drug each participant
description: Any AE of every subject appeared is recorded and traced after signing ICF,until remission of AE.
arm group label: TB subjects in 5-18 years old
arm group type: Experimental
description: 24 cases TB subjects in 5-18 years old are injected ESAT6-CFP10 in left arm and TB-PPD in right arm or ESAT6-CFP10 in right arm and TB-PPD in left arm. For each of participant,the person in this clinical research, the study uniform is that every subject injects firstly left arm, observe no obvious adverse reaction, then another drug inject in right arm. Measure the induration and (or) redness of longitudinal diameter size and transverse diameter vernier caliper by vernier caliper after injection 24h, 48h and 72h.
arm group label: non-TB subjects in 5-18 years old
arm group type: Experimental
description: 24 cases non-TB subjects in 5-18 years old are injected ESAT6-CFP10 in left arm and TB-PPD in right arm or ESAT6-CFP10 in right arm and TB-PPD in left arm. For each of participant,the person in this clinical research, the study uniform is that every subject injects firstly left arm, observe no obvious adverse reaction, then another drug inject in right arm. Measure the induration and (or) redness of longitudinal diameter size and transverse diameter vernier caliper by vernier caliper after injection 24h, 48h and 72h.
arm group label: TB subjects under 5 years old
arm group type: Experimental
description: 24 cases TB subjects under 5 years old are injected ESAT6-CFP10 in left arm and TB-PPD in right arm or ESAT6-CFP10 in right arm and TB-PPD in left arm. For each of participant,the person in this clinical research, the study uniform is that every subject injects firstly left arm, observe no obvious adverse reaction, then another drug inject in right arm. Measure the induration and (or) redness of longitudinal diameter size and transverse diameter vernier caliper by vernier caliper after injection 24h, 48h and 72h.
arm group label: non-TB subjects under 5 years old
arm group type: Experimental
description: 24 cases non-TB subjects under 5 years old are injected ESAT6-CFP10 in left arm and TB-PPD in right arm or ESAT6-CFP10 in right arm and TB-PPD in left arm. For each of participant,the person in this clinical research, the study uniform is that every subject injects firstly left arm, observe no obvious adverse reaction, then another drug inject in right arm. Measure the induration and (or) redness of longitudinal diameter size and transverse diameter vernier caliper by vernier caliper after injection 24h, 48h and 72h.
intervention type: Biological
intervention name: ESAT6-CFP10 in left arm and TB-PPD in right arm
description: All subjects including TB subjects in 5-18 years old、non-TB subjects in 5-18 years old、TB subjects under 5 years old and non-TB subjects under 5 years old inject ESAT6-CFP10 in left arm and TB-PPD in right arm respectively. Two drug must use at the same participant and in different arms.
arm group label: TB subjects in 5-18 years old
arm group label: TB subjects under 5 years old
arm group label: non-TB subjects in 5-18 years old
arm group label: non-TB subjects under 5 years old
intervention type: Biological
intervention name: ESAT6-CFP10 in right arm and TB-PPD in left arm
description: All subjects including TB subjects in 5-18 years old、non-TB subjects in 5-18 years old、TB subjects under 5 years old and non-TB subjects under 5 years old inject ESAT6-CFP10 in right arm and TB-PPD in left arm respectively. Two drug must use at the same participant and in different arms.
arm group label: TB subjects in 5-18 years old
arm group label: TB subjects under 5 years old
arm group label: non-TB subjects in 5-18 years old
arm group label: non-TB subjects under 5 years old
criteria: 
gender: All
minimum age: N/A
maximum age: 17 Years
healthy volunteers: No
last name: Shuihua Lu, BBachelor
role: Principal Investigator
affiliation: Shanghai Public Health Clinical Center
facility: 
facility: 
facility: 
facility: 
country: China
citation: van Pinxteren LA, Ravn P, Agger EM, Pollock J, Andersen P. Diagnosis of tuberculosis based on the two specific antigens ESAT-6 and CFP10. Clin Diagn Lab Immunol. 2000 Mar;7(2):155-60. doi: 10.1128/CDLI.7.2.155-160.2000.
PMID: 10702486
citation: Brusasca PN, Colangeli R, Lyashchenko KP, Zhao X, Vogelstein M, Spencer JS, McMurray DN, Gennaro ML. Immunological characterization of antigens encoded by the RD1 region of the Mycobacterium tuberculosis genome. Scand J Immunol. 2001 Nov;54(5):448-52. doi: 10.1046/j.1365-3083.2001.00975.x.
PMID: 11696195
citation: Weldingh K, Andersen P. ESAT-6/CFP10 skin test predicts disease in M. tuberculosis-infected guinea pigs. PLoS One. 2008 Apr 23;3(4):e1978. doi: 10.1371/journal.pone.0001978.
PMID: 18431468
citation: Aagaard C, Govaerts M, Meikle V, Vallecillo AJ, Gutierrez-Pabello JA, Suarez-Guemes F, McNair J, Cataldi A, Espitia C, Andersen P, Pollock JM. Optimizing antigen cocktails for detection of Mycobacterium bovis in herds with different prevalences of bovine tuberculosis: ESAT6-CFP10 mixture shows optimal sensitivity and specificity. J Clin Microbiol. 2006 Dec;44(12):4326-35. doi: 10.1128/JCM.01184-06. Epub 2006 Sep 27.
PMID: 17005738
responsible party type: Sponsor
mesh term: Tuberculosis
mesh term: Disease
sharing ipd: No