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

Primary Purpose

Tuberculosis

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Bacillus Calmette - Guerin

placebo of Bacillus Calmette - Guerin

About this trial

This is an interventional diagnostic trial for Tuberculosis focused on measuring ESAT6, CFP10, skin test, diagnostic test

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria of the screening crowd

18-65 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;

Exclusion Criteria of the screening crowd

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.

Inclusion Criteria of three negative crowd

conforming to the inclusion criteria of the screening crowd ;
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

conforming to the exclusion criteria of the screening crowd ;
With BCG vaccination taboo .

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

ESAT6-CFP10 in the right arm

ESAT6-CFP10 in the left arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of study population III Negative for Reaction 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

Secondary Outcome Measures

the number of participants with Adverse Events after Intradermal injection

Full Information

NCT ID

NCT02795260

First Posted

March 14, 2016

Last Updated

September 29, 2020

Sponsor

Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

Collaborators

Air Force Military Medical University, China, Proswell Medical Corporation, Jiangsu Province Centers for Disease Control and Prevention, Jurong Centers for Disease Control and Prevention

1. Study Identification

Unique Protocol Identification Number

NCT02795260

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

May 2016 (undefined)

Primary Completion Date

October 2016 (Actual)

Study Completion Date

October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

Collaborators

Air Force Military Medical University, China, Proswell Medical Corporation, Jiangsu Province Centers for Disease Control and Prevention, Jurong Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tuberculosis

Keywords

ESAT6, CFP10, skin test, diagnostic test

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

1802 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ESAT6-CFP10 in the right arm

Arm Type

Experimental

Arm Description

Arm Title

ESAT6-CFP10 in the left arm

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Bacillus Calmette - Guerin

Other Intervention Name(s)

BCG

Intervention Description

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 .

Intervention Type

Biological

Intervention Name(s)

placebo of Bacillus Calmette - Guerin

Other Intervention Name(s)

placebo of BCG

Intervention Description

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 .

Primary Outcome Measure Information:

Title

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

Time Frame

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

Title

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

Time Frame

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

Secondary Outcome Measure Information:

Title

the number of participants with Adverse Events after Intradermal injection

Time Frame

within 48 hours after after Intradermal injection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria of the screening crowd 18-65 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; Exclusion Criteria of the screening crowd 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. Inclusion Criteria of three negative crowd conforming to the inclusion criteria of the screening crowd ; 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 conforming to the exclusion criteria of the screening crowd ; With BCG vaccination taboo .

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wei Lu, Master

Organizational Affiliation

Jiangsu Province Centers for Disease Control and Prevention

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

15817755

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. doi: 10.1128/CDLI.12.4.491-496.2005.

Results Reference

background

PubMed Identifier

11696195

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.

Results Reference

background

PubMed Identifier

18431468

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.

Results Reference

background

PubMed Identifier

17005738

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.

Results Reference

background

Links:

URL

http://www.cde.org.cn/

Description

CENTER FOR DRUG EVALUATION,NMPA

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

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