Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 on Healthy People Aged 18-65(III-healthy)

NCT02795260 | Completed Phase 3

• 1 other identifier: EC-III-healthy
• Study Type: interventional
• Target: 1,802
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators recruit about 1800 cases participants who has signed ICF,then do some physical examinations for these people, including ecg, X-ray, HIV,blood pressure, specific gamma-interferon detection ,collection of medical history and the like .These subjects who meet the standard are considered as study population I. Population I are injected intradermally with ESAT6-CFP10 and Tuberculin purified protein derivative(TB-PPD) at different arm of the same subject and get at least 360 participants whose three kinds of detection result are all negative and are considered as study population II.Then,they are immune to the Bacillus Calmette -Guerin(BCG) vaccine or the placebo of the BCG.Do specific gamma-interferon detection before the skin test,then inject intradermally with ESAT6-CFP10 and TB-PPD at different arm of the same subject 12 weeks after immunity.

Conditions

Tuberculosis

Keywords

ESAT6; CFP10; skin test; diagnostic test

Outcome Measures

Primary Outcomes (2)

• Number of study population III Negative for Reaction at 24 hours After intradermal injection with EC or TB-PPD

  At 24 hours after Intradermal injection with EC or TB-PPD

• Number of study population III Negative for Reaction at 48 hours After intradermal injection with EC or TB-PPD

  At 48 hours after Intradermal injection with EC or TB-PPD

Secondary Outcomes (1)

• the number of participants with Adverse Events after Intradermal injection

  within 48 hours after after Intradermal injection

Study Arms (2)

ESAT6-CFP10 in the right arm

EXPERIMENTAL

Each volunteer is intradermally injected two agents in different arms 12 weeks after Bacillus Calmette - Guerin (BCG) or placebo of BCG immunization :ESAT6-CFP10 in the right arm and TB-PPD in the left arm concomitantly,according to a randomisation scheme.

Biological: Bacillus Calmette - Guerin; Biological: placebo of Bacillus Calmette - Guerin

ESAT6-CFP10 in the left arm

EXPERIMENTAL

Each volunteer is intradermally injected two agents in different arms 12 weeks after Bacillus Calmette - Guerin (BCG) or placebo of Bacillus Calmette - Guerin immunization :ESAT6-CFP10 in the left arm and TB-PPD in the right arm concomitantly,according to a randomisation scheme.

Biological: Bacillus Calmette - Guerin; Biological: placebo of Bacillus Calmette - Guerin

Interventions

Bacillus Calmette - Guerin BIOLOGICAL

The participants are injection intradermally with 0.1ml ESAT6-CFP10(EC) in the right OR left arm and TB-PPD in the other arm(right OR left) after 12 weeks immunization of BCG .

Also known as: BCG

ESAT6-CFP10 in the left arm; ESAT6-CFP10 in the right arm

placebo of Bacillus Calmette - Guerin BIOLOGICAL

The participants are injection intradermally with 0.1ml ESAT6-CFP10(EC) in the right OR left arm and TB-PPD in the other arm(right OR left) after 12 weeks immunization of placebo of BCG .

Also known as: placebo of BCG

ESAT6-CFP10 in the left arm; ESAT6-CFP10 in the right arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old;
• consent and signed informed consent form;
• comply with follow-up;
• No history of tuberculosis;
• Physical condition:no obvious heart,liver,kidney, digestive tract,nervous system,mental disorder from signed informed consent to the injection;
• Normal axillary temperature (quiet condition blow 37.0℃)
• No abnormal chest by X-ray check;

You may not qualify if:

• Has the following serious disease, such as advanced cancer, diabetes, chronic obstructive pulmonary disease (copd) in acute episodes, acute/ progressive liver disease or kidney disease, congestive heart failure, etc;
• Epilepsy and psychiatric patients
• Has known or suspected (or risk possible) immune damaged or abnormal functional , accept glucocorticoid and immunosuppressants or immunopotentiator treatment, outside the gastrointestinal tract protein or blood products or plasma extraction in 3 months；
• Has acute febrile diseases and infectious diseases;
• taking part in any other new drug clinical trials or participated in any other new drug clinical trials within 3 months before this trials;
• a clear history of drug allergy ；
• In pregnancy or lactation；
• There is a clear history of high blood pressure and systolic blood pressure ≥180mmHg , and/or diastolic blood pressure of ≥ 100mmHg after drug control ；
• Researchers consider that any conditions may affect the trial evaluation.
• the result of four detection methods are all the negative: ESAT6-CFP10 、 TB - PPD and specific gamma - IFN and HIV;
• With BCG vaccination taboo .

Sponsors & Collaborators

• Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.: lead
• Air Force Military Medical University, China: collaborator
• Proswell Medical Corporation: collaborator
• Jiangsu Province Centers for Disease Control and Prevention: collaborator
• Jurong Centers for Disease Control and Prevention: collaborator

Related Publications (4)

• 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

Related Links

• CENTER FOR DRUG EVALUATION,NMPA

MeSH Terms

Conditions

Tuberculosis

Interventions

BCG Vaccine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tuberculosis Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Wei Lu, Master

  Jiangsu Province Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2016
• First Posted: June 10, 2016
• Study Start: May 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 1, 2020

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share