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TuberculosisPhase 3NCT02795260

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

A Phase 3 study testing Bacillus Calmette - Guerin in people with Tuberculosis, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Tuberculosis
What is being tested?
Bacillus Calmette - Guerin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,802 participants
Where
No sites listed yet
Study dates
May 2016to Oct 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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℃)
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  • No abnormal chest by X-ray check;
  • 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;

Who cannot join

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

About this study

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

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.

Read the 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.

Conditions
Tuberculosis
Being tested
Bacillus Calmette - Guerin, placebo of Bacillus Calmette - Guerin
Keywords
ESAT6, CFP10, skin test, diagnostic test
Medical subject headings
Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bacillus Calmette - GuerinBiological

    Also called BCG

    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 - GuerinBiological

    Also called placebo of BCG

    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 .

Study groups in NCT02795260
Study groupRoleWhat they receive
ESAT6-CFP10 in the right armExperimentalEach 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.
Receives: Biological: Bacillus Calmette - Guerin; Biological: placebo of Bacillus Calmette - Guerin
ESAT6-CFP10 in the left armExperimentalEach 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.
Receives: Biological: Bacillus Calmette - Guerin; Biological: placebo of Bacillus Calmette - Guerin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

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

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

Secondary outcomes (1)

  1. the number of participants with Adverse Events after Intradermal injection

    Measured: within 48 hours after after Intradermal injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2016 (estimated)
  2. Study startMay 2016
  3. Primary completionOct 2016
  4. Study completionOct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,802 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02795260
Sponsor's protocol ID
EC-III-healthy
Status last verified
Jan 2017
First submitted
14 Mar 2016
Last updated
1 Oct 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 15817755

  • 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.

    PubMed 11696195

  • 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.

    PubMed 18431468

  • 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.

    PubMed 17005738

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bacillus Calmette - Guerin in people with Tuberculosis, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02795260, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2020.

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