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

NCT02336542 | Completed Phase 2

• 1 other identifier: LTao-IIb-patient
• Study Type: interventional
• Target: 192
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Tuberculosis

Keywords

diagnosis of Tuberculosis; ESAT6; CFP10; skin test; diagnostic test

Outcome Measures

Primary Outcomes (5)

• 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

  within 72h after injection

• 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

  within 72h after injection

• 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

  within 72h after injection

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

  before administered intradermally

• 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

  within 72h after injection

Secondary Outcomes (4)

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

  within 72h after injection two drugs

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

  within 72h after injection

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

  within 72h after injection

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

  within 72h after injection

Study Arms (2)

TB subjects

EXPERIMENTAL

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

non-TB subjects with lung disease

ACTIVE COMPARATOR

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

5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm BIOLOGICAL

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.

TB subjects; non-TB subjects with lung disease

5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm BIOLOGICAL

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.

TB subjects; non-TB subjects with lung disease

10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm BIOLOGICAL

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.

TB subjects; non-TB subjects with lung disease

10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm BIOLOGICAL

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.

TB subjects; non-TB subjects with lung disease

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.: lead
• Shanghai Public Health Clinical Center: collaborator
• Tianjin Haihe Hospital: collaborator
• Wuhan Institute for Tuberculosis Control: collaborator
• Proswell Medical Corporation: collaborator
• Air Force Military Medical University, China: collaborator

Related Publications (6)

• 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 BACKGROUND

• 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.

  PMID: 15817755 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 34021314 DERIVED

Related Links

• Center for drug evaluation, CFDA ,China

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Shuihua Lu, Bachelor

  Shanghai Public Health Clinical Center

  PRINCIPAL INVESTIGATOR

• Qi Wu, Master

  Tianjin Haihe Hospital

  PRINCIPAL INVESTIGATOR

• Weihua Wang, Doctor

  Wuhan Insititute for Tuberculosis Control

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2014
• First Posted: January 13, 2015
• Study Start: November 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: March 23, 2017

Record last verified: 2015-09

Data Sharing

• IPD Sharing: Will not share