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

Tuberculosis Clinical Trial

Official title:

Phase III Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 on Healthy People Aged 18-65,Adopting Randomized Blinded and Parallel Controlled Method

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02795260
• Other study ID #: EC-III-healthy
• Status: Completed
• Phase: Phase 3
• Start date: May 2016
• Est. completion date: October 2016

Study information

• Verified date: January 2017
• Source: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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(γ-IFN) ,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(specific gamma-interferon detection ,TB-PPD and ESAT6-CFP10 ) and are considered as study population II.Then,they are immune to the Bacillus Calmette -Guerin(BCG) vaccine or the placebo of the BCG(BCG and the palcebo ratio of 2:1 ),they are incorporated into the Population III. 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. Evaluate the specificity of the ESAT6-CFP10 allergen by negative coincidence rate for BCG vaccinated crowd ,and the safety of ESAT6-CFP10 in all participant,and the correlation between ESAT6-CFP10 ,TB-PPD and γ-IFN.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1802
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria of the screening crowd

1. 18-65 years old;

2. consent and signed informed consent form;

3. comply with follow-up;

4. No history of tuberculosis;

5. Physical condition:no obvious heart,liver,kidney, digestive tract,nervous system,mental disorder from signed informed consent to the injection;

6. Normal axillary temperature (quiet condition blow 37.0?)

7. No abnormal chest by X-ray check;

Exclusion Criteria of the screening crowd

1. 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;

2. Epilepsy and psychiatric patients

3. 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;

4. Has acute febrile diseases and infectious diseases;

5. taking part in any other new drug clinical trials or participated in any other new drug clinical trials within 3 months before this trials;

6. a clear history of drug allergy ;

7. In pregnancy or lactation;

8. There is a clear history of high blood pressure and systolic blood pressure =180mmHg , and/or diastolic blood pressure of = 100mmHg after drug control ;

9. Researchers consider that any conditions may affect the trial evaluation.

Inclusion Criteria of three negative crowd

1. conforming to the inclusion criteria of the screening crowd ;

2. the result of four detection methods are all the negative: ESAT6-CFP10 ? TB - PPD and specific gamma - IFN and HIV;

Exclusion Criteria of three negative crowd

1. conforming to the exclusion criteria of the screening crowd ;

2. With BCG vaccination taboo .

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Biological:
• Bacillus Calmette - Guerin
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 .
• placebo of Bacillus Calmette - Guerin
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 .

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.	Fourth Military Medical University, Jiangsu Province Centers for Disease Control and Prevention, Jurong Centers for Disease Control and Prevention, Proswell Medical Corporation

References & Publications (4)

Aagaard C, Govaerts M, Meikle V, Vallecillo AJ, Gutierrez-Pabello JA, Suarez-Güemes 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. Epub 2006 Sep 27. — View 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. — View Citation

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	the number of participants with Adverse Events after Intradermal injection		within 48 hours after after Intradermal injection

External Links

•   CENTER FOR DRUG EVALUATION,NMPA