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CompletedNCT02336542Updated Mar 23, 2017

Phase IIb Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10

A Phase 2 interventional study of 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm and 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm in Tuberculosis, sponsored by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-03-23.

Sponsored by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. · Phase 2, Interventional, and Diagnostic

Phase
Phase 2
Study type
Interventional
Enrollment
192
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

96 TB subjects and 96 non-TB subjects with lung disease who all meet the standard are divided into different groups through a randomized, blind methods.Every subject inject intradermally ESAT6-CFP10 and TB-PPD in different arms of the same person.Specific γ- IFN(gamma interferon) detection is needed before the injection.Evaluate the sensitivity (positive coincidence rate) ,the specificity (negative coincidence rate) and the coincidence rate of ESAT6-CFP10 in the tuberculosis patients and non-tuberculosis patients with lung diseases, and determine the optimal dose of ESAT6-CFP10 for clinical auxiliary diagnosis of tuberculosis.

Read the detailed description

Firstly,96 TB(Tuberculosis ) subjects which meet the standard respectively are divided into different groups through a randomized, blind methods.

  1. ESAT6-CFP10 （5μg/ml）in left arm；
  2. ESAT6-CFP10 （5μg/ml）in right arm；
  3. ESAT6-CFP10 （10μg/ml）in left arm；
  4. ESAT6-CFP10 （10μg/ml）in right arm； Inject intradermally ESAT6-CFP10 and TB-PPD(tuberculin purified protein derivative ) in different arms of the same subject.For each of the participants in this clinical research, this study uniform that left arm inject a drug(ESAT6-CFP10 or TB - PPD) first, observe 30 min and no no obvious adverse reaction ,then another drug(ESAT6-CFP10 or TB - PPD) inject in right arm. We need draw blood to detect specific γ- IFN before the injection.Observe and record the vital signs (breathing, heart rate, blood pressure and temperature),the skin reaction diameter of injection site (flush and induration) , local reactions (rash, pain, itching and skin mucous membrane) and a variety of adverse events.

Secondly, 96 non-TB subjects with lung disease are divided into different groups and the procedure are as the same as 96 TB subjects above .

Finally,we evaluate the sensitivity (positive coincidence rate) ,the specificity (negative coincidence rate) and the coincidence rate of ESAT6-CFP10 in the TB patients and non-tuberculosis patients with lung diseases,determine the optimal dose of ESAT6-CFP10 for clinical auxiliary diagnosis of tuberculosis,and further evaluate the safety of ESAT6-CFP10 for the clinical auxiliary diagnosis of tuberculosis .

02

Conditions studied

  • Tuberculosis

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Keywords

  • diagnosis of Tuberculosis
  • ESAT6
  • CFP10
  • skin test
  • diagnostic test
03

In context

Tuberculosis

1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.

This study's enrollment of 192 is above the median of 150 across 952 interventional studies indexed under Tuberculosis.

Browse Tuberculosis studies →

Lead sponsor

Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. is the lead sponsor of 45 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis TB ;
  • 18 to 65 years ;
  • Consent and signed informed consent forms(ICF) ;
  • Comply with follow-up .

Exclusion criteria

Exclusion Criteria of TB (tuberculosis ) subjects:

  • advanced cancer, diabetes,copd in acute episodes, acute/ progressive liver disease or kidney disease, congestive heart failure, etc ;
  • Taking part in other clinical or within 3 months involved in any other clinical;
  • histories of allergy ;
  • in pregnancy or lactation;
  • In a mental illness ;
  • Any conditions affect the trial evaluation.

Inclusion Criteria of Non-tuberculosis subjects with lung disease :

  • Diagnosis non-tuberculosis subjects with lung disease ;
  • 18 to 65 years ;
  • Consent and signed signed informed consent forms(ICF) ;
  • Comply with follow-up .

Exclusion Criteria of Non-tuberculosis subjects with lung disease :

  • advanced cancer, diabetes,copd in acute episodes, acute/ progressive liver disease or kidney disease, congestive heart failure, etc ;
  • Taking part in other clinical or within 3 months involved in any other clinical;
  • histories of allergy;
  • in pregnancy or lactation;
  • In a mental illness ;
  • Any conditions may affect the trial evaluation.
05

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
192 participants (actual)

Study arms

  • Experimental
    TB subjects

    96 TB subjects are divided into four groups average .24 TB subjects are injected 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm.

    Biological: 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm · Biological: 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm · Biological: 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm · Biological: 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm

  • Active comparator
    non-TB subjects with lung disease

    96 non-TB subjects with lung disease are divided into four groups average .24 TB subjects are injected 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm.

    Biological: 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm · Biological: 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm · Biological: 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm · Biological: 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm

Interventions

  • Biological5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm

    TB subjects and non-TB subjects with lung disease inject 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm respectively. Two drug must use at the same person and different arm.

  • Biological5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm

    TB subjects and non-TB subjects with lung disease inject 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm respectively. Two drug must use at the same person and different arm.

  • Biological10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm

    TB subjects and non-TB subjects with lung disease inject 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm respectively. Two drug must use at the same person and different arm.

  • Biological10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm

    TB subjects and non-TB subjects with lung disease inject 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm respectively. Two drug must use at the same person and different arm.

06

What researchers measure

Primary outcomes

  1. the diameter of induraton or redness within 72 hours after intradermal injection with ESAT6-CFP10 in TB patients

    we measure the size 15min,24h,48h,72h after administered intradermally ESAT6-CFP10

    Time frame: within 72h after injection

  2. the proportion of positive reaction within 72 hours after administered intradermally TB-PPD in TB patient

    we measure the size at 15min,24h,48h,72h after administered intradermally TB-PPD

    Time frame: within 72h after injection

  3. Immune response of of ESAT6-CFP10 from the size of induration OR redness in non-TB patients with lung diseases

    we measure the size at 15min,24h,48h,72h after administered intradermally TB-PPD

    Time frame: within 72h after injection

  4. The proportion of positive reaction after receiving specificity γ-IFN test in TB subjects and non-TB subjects with lung disease

    Time frame: before administered intradermally

  5. the proportion of positive reaction within 72 hours after intradermal injection with TB-PPD in non-TB patients with lung diseases

    we measure the size at 15min,24h,48h,72h after administered intradermally TB-PPD

    Time frame: within 72h after injection

Secondary outcomes

  1. the occurrence of adverse events within 72 hours after injection in TB subjects and non-TB subjects with lung disease

    Time frame: within 72h after injection two drugs

  2. the consistency between ESAT6-CFP10 and TB-PPD in TB subjects and non-TB subjects with lung disease

    Time frame: within 72h after injection

  3. the consistency between ESAT6-CFP10 and γ-IFN in TB subjects and non-TB subjects with lung disease

    Time frame: within 72h after injection

  4. the consistency between TB-PPD and γ-IFN in TB subjects and non-TB subjects with lung disease

    Time frame: within 72h after injection

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 10702486 ↗
  • Ravn P, Munk ME, Andersen AB, Lundgren B, Lundgren JD, Nielsen LN, Kok-Jensen A, Andersen P, Weldingh K. Prospective evaluation of a whole-blood test using Mycobacterium tuberculosis-specific antigens ESAT-6 and CFP-10 for diagnosis of active tuberculosis. Clin Diagn Lab Immunol. 2005 Apr;12(4):491-6. doi: 10.1128/CDLI.12.4.491-496.2005. PubMed 15817755 ↗
  • 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. PubMed 11696195 ↗
  • 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. PubMed 18431468 ↗
  • 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. PubMed 17005738 ↗
  • Xu M, Lu W, Li T, Li J, Du W, Wu Q, Liu Q, Yuan B, Lu J, Ding X, Li F, Liu M, Chen B, Pu J, Zhang R, Xi X, Zhou R, Mei Z, Du R, Tao L, Martinez L, Lu S, Wang G, Zhu F. Sensitivity, Specificity, and Safety of a Novel ESAT6-CFP10 Skin Test for Tuberculosis Infection in China: 2 Randomized, Self-Controlled, Parallel-Group Phase 2b Trials. Clin Infect Dis. 2022 Mar 1;74(4):668-677. doi: 10.1093/cid/ciab472. PubMed 34021314 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02336542
Lead sponsor
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Collaborators
Shanghai Public Health Clinical Center, Tianjin Haihe Hospital, Wuhan Institute for Tuberculosis Control, Proswell Medical Corporation, Air Force Military Medical University, China
Responsible party
Sponsor
First posted
Jan 13, 2015
Start date
Nov 2014
Primary completion
Jul 2015
Completion
Jul 2015
Last update
Mar 23, 2017

Study contacts

Shuihua Lu, Bachelor
principal investigator · Shanghai Public Health Clinical Center
Qi Wu, Master
principal investigator · Tianjin Haihe Hospital
Weihua Wang, Doctor
principal investigator · Wuhan Insititute for Tuberculosis Control

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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