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

September 29, 2020 updated by: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1802

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ESAT6-CFP10 in the right arm
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
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 .
Other Names:
  • BCG
Biological: 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 .
Other Names:
  • placebo of BCG
Experimental: ESAT6-CFP10 in the left arm
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
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 .
Other Names:
  • BCG
Biological: 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 .
Other Names:
  • placebo of BCG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
Time Frame: At 48 hours after Intradermal injection with EC or TB-PPD
At 48 hours after Intradermal injection with EC or TB-PPD

Secondary Outcome Measures

Outcome Measure
Time Frame
the number of participants with Adverse Events after Intradermal injection
Time Frame: within 48 hours after after Intradermal injection
within 48 hours after after Intradermal injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

Collaborators

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

Investigators

  • Principal Investigator: Wei Lu, Master, Jiangsu Province Centers for Disease Control and Prevention

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

March 14, 2016

First Submitted That Met QC Criteria

June 6, 2016

First Posted (Estimate)

June 10, 2016

Study Record Updates

Last Update Posted (Actual)

October 1, 2020

Last Update Submitted That Met QC Criteria

September 29, 2020

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC-III-healthy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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