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| Name | Class |
|---|---|
| Air Force Military Medical University, China | OTHER |
| Proswell Medical Corporation | INDUSTRY |
| Jiangsu Province Centers for Disease Control and Prevention | NETWORK |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 . |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| the number of participants with Adverse Events after Intradermal injection | within 48 hours after after Intradermal injection |
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Inclusion Criteria of the screening crowd
Exclusion Criteria of the screening crowd
Inclusion Criteria of three negative crowd
Exclusion Criteria of three negative crowd
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| Name | Affiliation | Role |
|---|---|---|
| Wei Lu, Master | Jiangsu Province Centers for Disease Control and Prevention | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15817755 | Background | 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. | |
| 11696195 |
| Label | URL |
|---|---|
| CENTER FOR DRUG EVALUATION,NMPA | View source |
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| Jurong Centers for Disease Control and Prevention |
| UNKNOWN |
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| 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 . |
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| 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. |
| 18431468 | 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. |
| 17005738 | 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. |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D001500 | BCG Vaccine |
| ID | Term |
|---|---|
| D032581 | Tuberculosis Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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