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| ID | Type | Description | Link |
|---|---|---|---|
| LTao | Registry Identifier | AnhuiZhifei |
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| Name | Class |
|---|---|
| Shanghai Public Health Clinical Center | OTHER_GOV |
| Air Force Military Medical University, China | OTHER |
| Proswell Medical Corporation | INDUSTRY |
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In the tests, small sample of clinical study about Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 ( Recombination EC Allergen） healthy adults was carried out.
24 healthy adults were included as study objects, they were randomly divided into four groups of different Recombinant Allergen EC dose (1, 5, 10μg/mL, maximum tolerated dose 20μg/mL, 6 person/dose) for single arm intradermal injection.
The main examination items :vital signs (breathing, heart rate, blood pressure, body temperature ) of each volunteer at 15min, 30min, 1h, 2h, 4h, 8h, 24h, 48h, 72h, 96h after injection, skin reactivity (redness and/or induration) diameter of injection sites,local reaction ( rash, pain, itching, and skin and mucous membranes ) ,a variety of adverse events,routine blood,routine urine, liver and kidney function, ECG and chest X-ray films before and 7 days after intradermal injection .
Preliminary evaluation of safety and tolerability of Recombinant Allergen EC applied in humans, which can provide a safe dosage range for phase II clinical study.
This clinical study adopts an open, randomized study methods to carry out Recombinant EC Allergen on small sample of healthy adults.
24 healthy adults were included as study objects, they were randomly divided into four groups of different Recombinant EC Allergen dose (1, 5, 10μg/mL, maximum tolerated dose 20μg/mL, 6 person/dose) for single arm intradermal injection, and set up two people as replacement for each group (one male and one female).
Intradermal injection into one third site of healthy subjects' left or right forearm palmaris with 0.1ml Recombinant EC Allergen for only one time.
The main examination items :vital signs (breathing, heart rate, blood pressure, body temperature ) of each volunteer at 15min, 30min, 1h, 2h, 4h, 8h, 24h, 48h, 72h, 96h after injection, skin reactivity (redness and/or induration) diameter of injection sites,local reaction ( rash, pain, itching, and skin and mucous membranes ) ,a variety of adverse events,routine blood,routine urine, liver and kidney function, ECG and chest X-ray films before and 7 days after intradermal injection .
In phaseⅠclinical study, each person can accept only one dose, After injection of the same dose of a volunteer group, be sure the next injection of a volunteer at 40 minutes interval. Different dose groups: the next dose test should be carried on in the case of no serious adverse events appear in 7days after the last one volunteer's injection in a former lower dose group.
Statistical analysis is performed using SAS9.3 software, and all analytic process is routinization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1μg/ml ESAT6-CFP10 | Experimental | The 1μg/ml ESAT6-CFP10 is given 0.1ml alone to volunteers in the RIGHT or LEFT forearm according to a randomisation scheme. |
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| 5μg/ml ESAT6-CFP10 | Experimental | The 5μg/ml ESAT6-CFP10 is given 0.1ml alone to volunteers in the RIGHT or LEFT forearm according to a randomisation scheme. |
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| 10μg/ml ESAT6-CFP10 | Experimental | The 10μg/ml ESAT6-CFP10 is given 0.1ml alone to volunteers in the RIGHT or LEFT forearm according to a randomisation scheme. |
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| 20μg/ml ESAT6-CFP10 | Experimental | The 20μg/ml ESAT6-CFP10 is given 0.1ml alone to volunteers in the RIGHT or LEFT forearm according to a randomisation scheme. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESAT6-CFP10 | Biological | 32 healthy subjects who meet the standard of protocol are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml ESAT6-CFP10、5μg/ml ESAT6-CFP10、10μg/ml ESAT6-CFP10、20μg/ml ESAT6-CFP10.Each dose group have six healthy subjects(three male and three female) , at the same time set up two people for substitute (one male and one female) . ESAT6-CFP10 administered intradermally by the mantoux injection technique. Each receives only one dosage in right or left arm . |
| Measure | Description | Time Frame |
|---|---|---|
| the Cases of Adverse Events With Participant Injection of ESAT6-CFP10 | The main examination items :vital signs (breathing, heart rate, blood pressure, body temperature ) of each volunteer at 15min, 30min, 1h, 2h, 4h, 8h, 24h, 48h, 72h, 96h after injection, skin reactivity (redness and/or induration) of injection sites,local reaction ( rash, pain, itching, and skin mucous membranes ) ,a variety of adverse events,routine blood,routine urine, liver and kidney function, ECG and chest X-ray films before and 7 days after intradermal injection . | within 7 days after the injections |
| Measure | Description | Time Frame |
|---|---|---|
| the Number of Participants Who Appear the Induration and/or Redness 2h After Application of ESAT6-CFP10 | We check the immune response( induration and/or redness) at 2h after application of ESAT6-CFP10 with vernier caliper. Using the standardized vernier caliper, measured transverse diameter and the longitudinal diameter of induration and/or redness in skin test parts if any participants appear induration and/or redness after application of ESAT6-CFP10. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shuihua Lu, Bachelor | Shanghai Public Health Clinical Center | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10702486 | Background | van Pinxteren LA, Ravn P, Agger EM, Pollock J, Andersen P. Diagnosis of tuberculosis based on the two specific antigens ESAT-6 and CFP10. Clin Diagn Lab Immunol. 2000 Mar;7(2):155-60. doi: 10.1128/CDLI.7.2.155-160.2000. | |
| 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. |
| Label | URL |
|---|---|
| Center for drug evaluation, CFDA ,China | View source |
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In September 4, 2013, the recruitment carried out in Shanghai Public Health Clinical Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1μg/ml ESAT6-CFP10 | We get 32 healthy subjects who all meet the standard of our protocol by comprehensive check-up and asked basic medical history .32 healthy subjects are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml ESAT6-CFP10、5μg/ml ESAT6-CFP10、10μg/ml ESAT6-CFP10、20μg/ml ESAT6-CFP10.Each dose group have six healthy subjects who are injected drug , at the same time set up two people for substitute (one male and one female) . Each participant intradermally inject only one dose of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 in one third site of left or right forearm palmaris .Within the same dose group two volunteer must be interval 40 minutes . Make sure 1μg/ml ESAT6-CFP10 group finally finished injection and observed seven days with no serious adverse reaction, then carry out 5μg/ml ESAT6-CFP10 groups . |
| FG001 | 5μg/ml ESAT6-CFP10 | We get 32 healthy subjects who all meet the standard of our protocol by comprehensive check-up and asked basic medical history .32 healthy subjects are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml ESAT6-CFP10、5μg/ml ESAT6-CFP10、10μg/ml ESAT6-CFP10、20μg/ml ESAT6-CFP10.Each dose group have six healthy subjects who are injected drug , at the same time set up two people for substitute (one male and one female) . Each participant intradermally inject only one dose of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 in one third site of left or right forearm palmaris .Within the same dose group two volunteer must be interval 40 minutes . Make sure 5μg/ml ESAT6-CFP10 group finally finished injection and observed seven days with no serious adverse reaction, then carry out 10μg/ml ESAT6-CFP10 groups . |
| FG002 | 10μg/ml ESAT6-CFP10 | We get 32 healthy subjects who all meet the standard of our protocol by comprehensive check-up and asked basic medical history .32 healthy subjects are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml ESAT6-CFP10、5μg/ml ESAT6-CFP10、10μg/ml ESAT6-CFP10、20μg/ml ESAT6-CFP10.Each dose group have six healthy subjects who are injected drug , at the same time set up two people for substitute (one male and one female) . Each participant intradermally inject only one dose of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 in one third site of left or right forearm palmaris .Within the same dose group two volunteer must be interval 40 minutes . Make sure 10μg/ml ESAT6-CFP10 group finally finished injection and observed seven days with no serious adverse reaction, then carry out 20μg/ml ESAT6-CFP10 groups . |
| FG003 | 20μg/ml ESAT6-CFP10 | We get 32 healthy subjects who all meet the standard of our protocol by comprehensive check-up and asked basic medical history .32 healthy subjects are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml ESAT6-CFP10、5μg/ml ESAT6-CFP10、10μg/ml ESAT6-CFP10、20μg/ml ESAT6-CFP10.Each dose group have six healthy subjects who are injected drug , at the same time set up two people for substitute (one male and one female) . Each participant intradermally inject only one dose of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 in one third site of left or right forearm palmaris .Within the same dose group two volunteer must be interval 40 minutes . |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Aged from 18 to 40 years old, the male to female ratio of cases is 1:1 in each group . Body mass index should be in the range of 20 to 27 .
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| ID | Title | Description |
|---|---|---|
| BG000 | 1μg/ml ESAT6-CFP10 | 24 healthy subjects who meet the standard of protocol are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、5μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、10μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、20μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10.Each dose group have six healthy subjects , at the same time set up two people for substitute (one male and one female) . |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | the Cases of Adverse Events With Participant Injection of ESAT6-CFP10 | The main examination items :vital signs (breathing, heart rate, blood pressure, body temperature ) of each volunteer at 15min, 30min, 1h, 2h, 4h, 8h, 24h, 48h, 72h, 96h after injection, skin reactivity (redness and/or induration) of injection sites,local reaction ( rash, pain, itching, and skin mucous membranes ) ,a variety of adverse events,routine blood,routine urine, liver and kidney function, ECG and chest X-ray films before and 7 days after intradermal injection . | ESAT6-CFP10 allergen similar to TB-PPD(Tuberculin purified protein derivative ), main ingredients are protein and can cause specific skin allergy in the injection site ( such as redness, swelling, induration, blisters), besides other local reactions, is still listed as adverse events . | Posted | Number | cases | within 7 days after the injections |
|
We collected and recorded all kinds of adverse event data within seven days after injection with ESAT6-CFP10.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1μg/ml ESAT6-CFP10 | Medicine Number 6 participant 24 h after test skin test, is observed local skin reactions and found subcutaneous hemorrhage ( 2 x 2 mm),48 h the subcutaneous hemorrhage is remain and becomes shallow ,72 h the subcutaneous hemorrhage is the same size and becomes lower shallow ,96 h the skin reaction has faded .This mild local skin reactions may be relevant with acupuncture of skin test , had nothing to do with experimental drugs by the judgement of principal investigator . Medicine Number 12 participant occurred two cases of adverse events the seventh days after skin test :respectively pregnancy and a small amount of pleural effusion on both sides .This volunteer test results of a pregnancy test paper were negative in screening period,pregnancy test result were positive the seventh days after the skin test. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Subcutaneous Hemorrhage Caused by Injection | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
If the operator don't have standard measurement of transverse diameter and the vertical diameter of induration or redness ,we get unreliable data .The participant lost any follow-up will lead to small numbers of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shuihua Lu | Shanghai Public Health Clinical Center | (+86)18930811818 | tubercle@gmail.com |
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| ID | Term |
|---|---|
| C505464 | ESAT-6-CFP10 fusion protein |
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| within 2h after application of ESAT6-CFP10 |
| the Number of Participants Who Appear the Induration and/or Redness 24h After Application of ESAT6-CFP10 | We check the immune response( induration and/or redness) at 24h after application of ESAT6-CFP10 with vernier caliper. Using the standardized vernier caliper, measured transverse diameter and the longitudinal diameter of induration and/or redness in skin test parts if any participants appear induration and/or redness after application of ESAT6-CFP10. | 24h after application of ESAT6-CFP10 |
| the Number of Participants Who Appear the Induration and/or Redness 48h After Application of ESAT6-CFP10 | We check the immune response( induration and/or redness) at 48h after application of ESAT6-CFP10 with vernier caliper. Using the standardized vernier caliper, measured transverse diameter and the longitudinal diameter of induration and/or redness in skin test parts if any participants appear induration and/or redness after application of ESAT6-CFP10. | 48h after application of ESAT6-CFP10 |
| the Number of Participants Who Appear the Induration and/or Redness 72h After Application of ESAT6-CFP10 | We check the immune response( induration and/or redness) at 72h after application of ESAT6-CFP10 with vernier caliper. Using the standardized vernier caliper, measured transverse diameter and the longitudinal diameter of induration and/or redness in skin test parts if any participants appear induration and/or redness after application of ESAT6-CFP10. | 72h after application of ESAT6-CFP10 |
| the Number of Participants Who Appear the Induration and/or Redness 96h After Application of ESAT6-CFP10 | We check the immune response( induration and/or redness) at 96h after application of ESAT6-CFP10 with vernier caliper. Using the standardized vernier caliper, measured transverse diameter and the longitudinal diameter of induration and/or redness in skin test parts if any participants appear induration and/or redness after application of ESAT6-CFP10. | 96h after application of ESAT6-CFP10 |
| 11696195 | Background | 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. |
| 27413070 | Derived | Li F, Xu M, Zhou L, Xiong Y, Xia L, Fan X, Gu J, Pu J, Lu S, Wang G. Safety of Recombinant Fusion Protein ESAT6-CFP10 as a Skin Test Reagent for Tuberculosis Diagnosis: an Open-Label, Randomized, Single-Center Phase I Clinical Trial. Clin Vaccine Immunol. 2016 Sep 6;23(9):767-73. doi: 10.1128/CVI.00154-16. Print 2016 Sep. |
| BG001 | 5μg/ml ESAT6-CFP10 | 24 healthy subjects who meet the standard of protocol are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、5μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、10μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、20μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10.Each dose group have six healthy subjects , at the same time set up two people for substitute (one male and one female) . |
| BG002 | 10μg/ml ESAT6-CFP10 | 24 healthy subjects who meet the standard of protocol are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、5μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、10μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、20μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10.Each dose group have six healthy subjects , at the same time set up two people for substitute (one male and one female) . |
| BG003 | 20μg/ml ESAT6-CFP10 | 24 healthy subjects who meet the standard of protocol are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、5μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、10μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、20μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10.Each dose group have six healthy subjects , at the same time set up two people for substitute (one male and one female) . |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
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| height | Mean | Standard Deviation | cm |
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Concentration of 1 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
| OG001 | 5μg/ml ESAT6-CFP10 | Concentration of 5 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose |
| OG002 | 10μg/ml ESAT6-CFP10 | Concentration of 10ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose |
| OG003 | 20μg/ml ESAT6-CFP10 | Concentration of 20 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; A single dose |
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| Secondary | the Number of Participants Who Appear the Induration and/or Redness 2h After Application of ESAT6-CFP10 | We check the immune response( induration and/or redness) at 2h after application of ESAT6-CFP10 with vernier caliper. Using the standardized vernier caliper, measured transverse diameter and the longitudinal diameter of induration and/or redness in skin test parts if any participants appear induration and/or redness after application of ESAT6-CFP10. | Induration and/or redness is our main immune response of ESAT6-CFP10. | Posted | Number | participants | within 2h after application of ESAT6-CFP10 |
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| Secondary | the Number of Participants Who Appear the Induration and/or Redness 24h After Application of ESAT6-CFP10 | We check the immune response( induration and/or redness) at 24h after application of ESAT6-CFP10 with vernier caliper. Using the standardized vernier caliper, measured transverse diameter and the longitudinal diameter of induration and/or redness in skin test parts if any participants appear induration and/or redness after application of ESAT6-CFP10. | Posted | Number | participants | 24h after application of ESAT6-CFP10 |
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| Secondary | the Number of Participants Who Appear the Induration and/or Redness 48h After Application of ESAT6-CFP10 | We check the immune response( induration and/or redness) at 48h after application of ESAT6-CFP10 with vernier caliper. Using the standardized vernier caliper, measured transverse diameter and the longitudinal diameter of induration and/or redness in skin test parts if any participants appear induration and/or redness after application of ESAT6-CFP10. | Posted | Number | participants | 48h after application of ESAT6-CFP10 |
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| Secondary | the Number of Participants Who Appear the Induration and/or Redness 72h After Application of ESAT6-CFP10 | We check the immune response( induration and/or redness) at 72h after application of ESAT6-CFP10 with vernier caliper. Using the standardized vernier caliper, measured transverse diameter and the longitudinal diameter of induration and/or redness in skin test parts if any participants appear induration and/or redness after application of ESAT6-CFP10. | Posted | Number | participants | 72h after application of ESAT6-CFP10 |
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| Secondary | the Number of Participants Who Appear the Induration and/or Redness 96h After Application of ESAT6-CFP10 | We check the immune response( induration and/or redness) at 96h after application of ESAT6-CFP10 with vernier caliper. Using the standardized vernier caliper, measured transverse diameter and the longitudinal diameter of induration and/or redness in skin test parts if any participants appear induration and/or redness after application of ESAT6-CFP10. | Posted | Number | participants | 96h after application of ESAT6-CFP10 |
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| 0 |
| 6 |
| 2 |
| 6 |
| EG001 | 5μg/ml ESAT6-CFP10 | Medicine Number 2 participant 15 min and 30 min after skin test is observed local skin reactions and all found that scattered red dot (32 x 25 mm )appeared .After 30min each time point local skin reactions were negative . This mild local skin reactions may be relevant with alcohol allergy , had nothing to do with experimental drugs by the judgement of principal investigator . | 0 | 6 | 1 | 6 |
| EG002 | 10μg/ml ESAT6-CFP10 | There is no adverse event. | 0 | 6 | 0 | 6 |
| EG003 | 20μg/ml ESAT6-CFP10 | There is no adverse event. | 0 | 6 | 0 | 6 |
| alcohol allergy caused by disinfection of the injection site | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| pregnancy | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment | This volunteer test results of a pregnancy test paper were negative in screening period,pregnancy test result were positive the seventh days after the skin test. |
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| a small amount of effusion in bilateral chest | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | The participant had trace pleural effusion before injection.7 days after injection found a small amount of effusion was in bilateral chest .Participant refused follow-up and not have any discomfort ,so effusion had nothing to do with drugs . |
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