NCT01999231|CompletedPhase 1Results
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Sponsor study identifier
Secondary identifiers
REGISTRY · AnhuiZhifei
interventional
32
0 countries
N/A
Study Start
September 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2013
Actual (reported)Study Completion
December 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2013
Date type not reportedThis date has not been verified as actual or estimated.
October 2013
Actual (reported)November 4, 2013
Actual (reported)December 2013
Actual (reported)December 3, 2013
Actual (reported)March 31, 2015
Actual (reported)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
the Number of Participants Who Appear the Induration and/or Redness 2h After Application of ESAT6-CFP10
within 2h after application of ESAT6-CFP10
the Number of Participants Who Appear the Induration and/or Redness 24h 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
48h after application of ESAT6-CFP10
the Number of Participants Who Appear the Induration and/or Redness 72h 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
96h after application of ESAT6-CFP10
The 1μg/ml ESAT6-CFP10 is given 0.1ml alone to volunteers in the RIGHT or LEFT forearm according to a randomisation scheme.
The 5μg/ml ESAT6-CFP10 is given 0.1ml alone to volunteers in the RIGHT or LEFT forearm according to a randomisation scheme.
The 10μg/ml ESAT6-CFP10 is given 0.1ml alone to volunteers in the RIGHT or LEFT forearm according to a randomisation scheme.
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 .
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
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.
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.
Shuihua Lu, Bachelor
Shanghai Public Health Clinical Center
32 participants (actual enrollment reported by the registry).
First Submitted
November 4, 2013
First Posted
December 3, 2013
Study Start
September 2013
Date type not reportedThis date has not been verified as actual or estimated.
The 20μg/ml ESAT6-CFP10 is given 0.1ml alone to volunteers in the RIGHT or LEFT forearm according to a randomisation scheme.
Contact the study team to confirm eligibility.
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.
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.
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.
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.
Primary Completion
October 2013
Actual (reported)Study Completion
December 2013
Actual (reported)Last Updated
March 31, 2015
Results First Posted
March 31, 2015
Record last verified: 2015-03
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Source: ClinicalTrials.gov.
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