TuberculosisPhase 2IIb-healthyNCT02389322
Phase IIb Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 on Healthy People Aged 18-65
A Phase 2 study testing 5μg/ml ESAT6-CFP10, 10μg/ml ESAT6-CFP10 and BCG in people with Tuberculosis, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 1 site in China.
Trial summary
The investigators select 500 subjects who meet the standard and are considered as study population I. Do specific gamma-interferon detection before the skin test， then inject intradermally with two dosage ESAT6-CFP10 and Tuberculin purified protein derivative (TB-PPD) at different arm of the same subject and get 192… 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?
- 5μg/ml ESAT6-CFP10, 10μg/ml ESAT6-CFP10 and BCG
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,044 participants
- Where
- 1 siteChina
- Study dates
- Mar 2015to Sep 2015
- Phase
- Phase 2
- 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 to 65 years old;
- Consent and signed informed consent forms(ICF);
- Comply with follow-up;
- No history of tuberculosis;
- Physical condition : No obvious heart, liver, kidney, gastrointestinal tract, nervous system, mental disorder and metabolic abnormalities and other medical history from signed informed consent to the injection within four weeks prior to delivery ;by the comprehensive physical examination showed electrocardiogram, blood pressure, heart rate, breathing and laboratory tests, including blood, urine routine, liver, kidney and other various biochemical test all without exception or slightly unusual but does not affect our research;
- Normal axillary temperature(quiet condition ≤37.0 ℃).
Show all 19Show fewer
- healthy people conforming to the study population Ⅰ criteria ;
- the result of three detection methods( ESAT6-CFP10 (5 μg/ml or 10 μg/ml)、 TB - PPD and specific gamma - IFN ) are all the negative ;
- Comply with two criteria the above (1) (2) , HIV negative, X-ray chest radiograph no abnormalities.
- Exclusion Criteria of study population Ⅰand study population Ⅱ:
- 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;
- Have epilepsy, brain and nervous system symptoms or signs of history or have risk tendency of epilepsy, brain and other nervous system disease and not easy to control;
- 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, immunodeficiency virus infection or related diseases or long-term use of antibiotics;
- 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;
- allergy to drugs 、alcohol 、 vaccine、drugs using in this experiment and allergic or scar constitution;
- In pregnancy or lactation;
- With mental or physical disabilities;
- Researchers consider that any conditions may affect the trial evaluation.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site
Jurong Province Centers for Disease Control and Prevention
Jurong, Jiangsu
About this study
Official title: Phase IIb Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 on Healthy People Aged 18-65,Adopting Randomized Blinded and Parallel Controlled Method
The investigators select 500 subjects who meet the standard and are considered as study population I. Do specific gamma-interferon detection before the skin test， then inject intradermally with two dosage ESAT6-CFP10 and Tuberculin purified protein derivative (TB-PPD) at different arm of the same subject and get 192 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 two dosage ESAT6-CFP10 and TB-PPD at different arm of the same subject 12 weeks after immunity.Negative rate of ESAT6-CFP10 after vaccination BCG as the main index , evaluate the specificity of different doses of ESAT6-CFP10, and conform the optimal dose of ESAT6-CFP10.
Read the detailed description
1.the correlation of three detection methods for study population I
500 study population I are randomly divided into two different dose group on average, according to ESAT6-CFP10 dose(5μg/ml or 10μg/ml). Do specific gamma-interferon(γ-IFN) detection before the skin test，then inject intradermally with 5μg/ml ESAT6-CFP10 or 10μg/ml ESAT6-CFP10 and TB-PPD at different arm of the same subject.Evaluate respectively the positive rate of three detection methods 、the correlation of three detection methods and the security of study population I after application for ESAT6-CFP10 .
2.screen study population II
Choose those participants, whose result of three detection (ESAT6-CFP10、TB-PPD andγ-IFN ) all negative, HIV negative and chest X-ray no abnormalities, into study population II.
3.study population II vaccinate BCG or placebo
Study population II ,according to the same proportion ,are randomly divided into four group in double blinded state,: 5μg/ml ESAT6-CFP10 after BCG immunization, 10μg/ml ESAT6-CFP10 after BCG immunization, 5μg/ml ESAT6-CFP10 after placebo-controlled immunization , 10μg/ml ESAT6-CFP10 after placebo-controlled immunization.They vaccinate BCG or the placebo of BCG.
4.Inject ESAT6-CFP10 12 weeks after inoculation in study population II
The investigators draw blood and operate specific gamma-interferon(γ-IFN) detection before the skin test，then inject intradermally with 5μg/ml ESAT6-CFP10 or 10μg/ml ESAT6-CFP10 (in double blinded state) and TB-PPD at different arm of the same subject ,according to the above grouping scheme.
Calculate the negative coincidence rate and the correlation of three detection methods, and observe the safety of ESAT6-CFP10 in study population II at the same time.Evaluate the specificity of different doses of ESAT6-CFP10, negative rate of ESAT6-CFP10 after vaccination BCG as the main index. And finally conform the optimal dose of ESAT6-CFP10.
- Conditions
- Tuberculosis
- Being tested
- 5μg/ml ESAT6-CFP10, 10μg/ml ESAT6-CFP10, BCG, placebo
- 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.
5μg/ml ESAT6-CFP10Biological
Also called 5μg/mlEC
The participants are injection intradermally with 0.1 ml 5μg/ml ESAT6-CFP10 12 weeks after BCG immunization or placebo immunization.This biological diagnostic reagents is injection agent .Every subject apply for the 5μg/mlRecombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 only one time after choosing into study population II .
10μg/ml ESAT6-CFP10Biological
Also called 10μg/ml EC
The participants are injection intradermally with 0.1 ml 10μg/ml ESAT6-CFP10 12 weeks after BCG immunization or placebo immunization.This biological diagnostic reagents is injection agent .Every subject apply for the 10μg/mlRecombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 only one time after choosing into study population II .
BCGBiological
Also called Bacillus Calmette-Guerin
The participants are injected intradermally with 0.1 ml BCG.This BCG is Freeze-dried agent and with five people dose of each bottle,so each bottle of BCG must dissolve by 0.5ml special diluent before administration.Every subject apply for the BCG vaccine only one time after choosing into study population II .
placeboBiological
The participants are injected intradermally with 0.1 ml placebo of Bacillus Calmette-Guerin.This placebo is Freeze-dried agent and with five people dose of each bottle ,so each bottle must dissolve by 0.5ml special diluent before administration.Every subject apply for the BCG vaccine only one time after choosing into study population II .
| Study group | Role | What they receive |
|---|---|---|
| 5μg/ml ESAT6-CFP10 after BCG immunization | Experimental | A within group paired comparison of 5μg/ mL ESAT6-CFP10 and TB-PPD in 48 person of study population II. The 5μg/ mL ESAT6-CFP10 and TB-PPD agents are given concomitantly to each volunteer in the right and left forearms 12 weeks after BCG immunization, according to a randomisation scheme . Receives: Biological: 5μg/ml ESAT6-CFP10; Biological: BCG |
| 10μg/ml ESAT6-CFP10 after BCG immunization | Experimental | A within group paired comparison of 10μg/ mL ESAT6-CFP10 and TB-PPD in 48 person of study population II. The 10μg/ mL ESAT6-CFP10 and TB-PPD agents are given concomitantly to each volunteer in the right and left forearms 12 weeks after BCG immunization, according to a randomisation scheme . Receives: Biological: 10μg/ml ESAT6-CFP10; Biological: BCG |
| 5μg/ml ESAT6-CFP10 after placebo immunization | Placebo comparator | A within group paired comparison of 5μg/ mL ESAT6-CFP10 and TB-PPD in 48 person of study population II. The 5μg/ mL ESAT6-CFP10 and TB-PPD agents are given concomitantly to each volunteer in the right and left forearms 12 weeks after placebo controlled immunization, according to a randomisation scheme . Receives: Biological: placebo |
| 10μg/ml ESAT6-CFP10 after placebo immunization | Placebo comparator | A within group paired comparison of 10μg/ mL ESAT6-CFP10 and TB-PPD in 48 person of study population II. The 10μg/ mL ESAT6-CFP10 and TB-PPD agents are given concomitantly to each volunteer in the right and left forearms 12 weeks after placebo controlled immunization, according to a randomisation scheme. Receives: Biological: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
immune response of ESAT6-CFP10 from the size of induration or redness in all population
We measure the size 24h,48h,72h after administered intradermally ESAT6-CFP10
Measured: within 72 Hours After Intradermal Injection With ESAT6-CFP10
immune response of TB-PPD from the size of induration or redness in all population
We measure the size 24h,48h,72h after administered intradermally TB-PPD
Measured: within 72 Hours After Intradermal Injection With TB-PPD
the results of specificity γ-IFN test in all subjects
Measured: before administered intradermally
Secondary outcomes (4)
the Number of Participants With Adverse Events
Measured: within 72 hours after injection
ESAT6-CFP10 cosistency with TB-PPD in all subjects
Measured: within 72 hours after injection
ESAT6-CFP10 cosistency with γ-IFN in all subjects
Measured: within 72 hours after injection
TB-PPD cosistency with γ-IFN in all subjects
Measured: within 72 hours after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,044 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Air Force Military Medical University, China, Proswell Medical Corporation, Jiangsu Province Centers for Disease Control and Prevention, Jurong Province Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Wei Lu, Master, Principal investigator, Jingsu Province Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02389322
- Sponsor's protocol ID
- EC-IIb-healthy
- Acronym
- IIb-healthy
- Status last verified
- Sep 2015
- First submitted
- 5 Mar 2015
- Last updated
- 17 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 10702486Ravn 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 15817755Brusasca 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 11696195Weldingh 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 18431468Aagaard 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 17005738Xu M, Lu W, Li T, Li J, Du W, Wu Q, Liu Q, Yuan B, Lu J, Ding X, Li F, Liu M, Chen B, Pu J, Zhang R, Xi X, Zhou R, Mei Z, Du R, Tao L, Martinez L, Lu S, Wang G, Zhu F. Sensitivity, Specificity, and Safety of a Novel ESAT6-CFP10 Skin Test for Tuberculosis Infection in China: 2 Randomized, Self-Controlled, Parallel-Group Phase 2b Trials. Clin Infect Dis. 2022 Mar 1;74(4):668-677. doi: 10.1093/cid/ciab472.
PubMed 34021314
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIb Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 on Healthy People Aged 18-65,Adopting Randomized Blinded and Parallel Controlled Method
- ClinicalTrials.gov ID
- NCT02389322
- Acronym / sponsor ID
- IIb-healthy / EC-IIb-healthy
- Conditions
- Tuberculosis
- Keywords
- ESAT6, CFP10, skin test, diagnostic test
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,044 participants (actual)
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Air Force Military Medical University, China, Proswell Medical Corporation, Jiangsu Province Centers for Disease Control and Prevention, Jurong Province Centers for Disease Control and Prevention
- Study start
- Mar 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators select 500 subjects who meet the standard and are considered as study population I. Do specific gamma-interferon detection before the skin test， then inject intradermally with two dosage ESAT6-CFP10 and Tuberculin purified protein derivative (TB-PPD) at different arm of the same subject and get 192 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 two dosage ESAT6-CFP10 and TB-PPD at different arm of the same subject 12 weeks after immunity.Negative rate of ESAT6-CFP10 after vaccination BCG as the main index , evaluate the specificity of different doses of ESAT6-CFP10, and conform the optimal dose of ESAT6-CFP10.
Detailed description
1.the correlation of three detection methods for study population I
500 study population I are randomly divided into two different dose group on average, according to ESAT6-CFP10 dose(5μg/ml or 10μg/ml). Do specific gamma-interferon(γ-IFN) detection before the skin test，then inject intradermally with 5μg/ml ESAT6-CFP10 or 10μg/ml ESAT6-CFP10 and TB-PPD at different arm of the same subject.Evaluate respectively the positive rate of three detection methods 、the correlation of three detection methods and the security of study population I after application for ESAT6-CFP10 .
2.screen study population II
Choose those participants, whose result of three detection (ESAT6-CFP10、TB-PPD andγ-IFN ) all negative, HIV negative and chest X-ray no abnormalities, into study population II.
3.study population II vaccinate BCG or placebo
Study population II ,according to the same proportion ,are randomly divided into four group in double blinded state,: 5μg/ml ESAT6-CFP10 after BCG immunization, 10μg/ml ESAT6-CFP10 after BCG immunization, 5μg/ml ESAT6-CFP10 after placebo-controlled immunization , 10μg/ml ESAT6-CFP10 after placebo-controlled immunization.They vaccinate BCG or the placebo of BCG.
4.Inject ESAT6-CFP10 12 weeks after inoculation in study population II
The investigators draw blood and operate specific gamma-interferon(γ-IFN) detection before the skin test，then inject intradermally with 5μg/ml ESAT6-CFP10 or 10μg/ml ESAT6-CFP10 (in double blinded state) and TB-PPD at different arm of the same subject ,according to the above grouping scheme.
Calculate the negative coincidence rate and the correlation of three detection methods, and observe the safety of ESAT6-CFP10 in study population II at the same time.Evaluate the specificity of different doses of ESAT6-CFP10, negative rate of ESAT6-CFP10 after vaccination BCG as the main index. And finally conform the optimal dose of ESAT6-CFP10.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 5μg/ml ESAT6-CFP10 after BCG immunization | Experimental | Biological: 5μg/ml ESAT6-CFP10, Biological: BCGA within group paired comparison of 5μg/ mL ESAT6-CFP10 and TB-PPD in 48 person of study population II. The 5μg/ mL ESAT6-CFP10 and TB-PPD agents are given concomitantly to each volunteer in the right and left forearms 12 weeks after BCG immunization, according to a randomisation scheme . |
| 10μg/ml ESAT6-CFP10 after BCG immunization | Experimental | Biological: 10μg/ml ESAT6-CFP10, Biological: BCGA within group paired comparison of 10μg/ mL ESAT6-CFP10 and TB-PPD in 48 person of study population II. The 10μg/ mL ESAT6-CFP10 and TB-PPD agents are given concomitantly to each volunteer in the right and left forearms 12 weeks after BCG immunization, according to a randomisation scheme . |
| 5μg/ml ESAT6-CFP10 after placebo immunization | Placebo comparator | Biological: placeboA within group paired comparison of 5μg/ mL ESAT6-CFP10 and TB-PPD in 48 person of study population II. The 5μg/ mL ESAT6-CFP10 and TB-PPD agents are given concomitantly to each volunteer in the right and left forearms 12 weeks after placebo controlled immunization, according to a randomisation scheme . |
| 10μg/ml ESAT6-CFP10 after placebo immunization | Placebo comparator | Biological: placeboA within group paired comparison of 10μg/ mL ESAT6-CFP10 and TB-PPD in 48 person of study population II. The 10μg/ mL ESAT6-CFP10 and TB-PPD agents are given concomitantly to each volunteer in the right and left forearms 12 weeks after placebo controlled immunization, according to a randomisation scheme. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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;
- Have epilepsy, brain and nervous system symptoms or signs of history or have risk tendency of epilepsy, brain and other nervous system disease and not easy to control;
- 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, immunodeficiency virus infection or related diseases or long-term use of antibiotics;
- 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;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5μg/ml ESAT6-CFP10Also: 5μg/mlECThe participants are injection intradermally with 0.1 ml 5μg/ml ESAT6-CFP10 12 weeks after BCG immunization or placebo immunization.This biological diagnostic reagents is injection agent .Every subject apply for the 5μg/mlRecombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 only one time after choosing into study population II . | Biological | 5μg/ml ESAT6-CFP10 after BCG immunization |
| 10μg/ml ESAT6-CFP10Also: 10μg/ml ECThe participants are injection intradermally with 0.1 ml 10μg/ml ESAT6-CFP10 12 weeks after BCG immunization or placebo immunization.This biological diagnostic reagents is injection agent .Every subject apply for the 10μg/mlRecombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 only one time after choosing into study population II . | Biological | 10μg/ml ESAT6-CFP10 after BCG immunization |
| BCGAlso: Bacillus Calmette-GuerinThe participants are injected intradermally with 0.1 ml BCG.This BCG is Freeze-dried agent and with five people dose of each bottle,so each bottle of BCG must dissolve by 0.5ml special diluent before administration.Every subject apply for the BCG vaccine only one time after choosing into study population II . | Biological | 10μg/ml ESAT6-CFP10 after BCG immunization, 5μg/ml ESAT6-CFP10 after BCG immunization |
| placeboThe participants are injected intradermally with 0.1 ml placebo of Bacillus Calmette-Guerin.This placebo is Freeze-dried agent and with five people dose of each bottle ,so each bottle must dissolve by 0.5ml special diluent before administration.Every subject apply for the BCG vaccine only one time after choosing into study population II . | Biological | 10μg/ml ESAT6-CFP10 after placebo immunization, 5μg/ml ESAT6-CFP10 after placebo immunization |
Primary outcome
immune response of ESAT6-CFP10 from the size of induration or redness in all population
Time frame: within 72 Hours After Intradermal Injection With ESAT6-CFP10
We measure the size 24h,48h,72h after administered intradermally ESAT6-CFP10
immune response of TB-PPD from the size of induration or redness in all population
Time frame: within 72 Hours After Intradermal Injection With TB-PPD
We measure the size 24h,48h,72h after administered intradermally TB-PPD
the results of specificity γ-IFN test in all subjects
Time frame: before administered intradermally
4 secondary outcomes
the Number of Participants With Adverse Events
Time frame: within 72 hours after injection
ESAT6-CFP10 cosistency with TB-PPD in all subjects
Time frame: within 72 hours after injection
ESAT6-CFP10 cosistency with γ-IFN in all subjects
Time frame: within 72 hours after injection
TB-PPD cosistency with γ-IFN in all subjects
Time frame: within 72 hours after injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
- Background: PubMed 10702486van 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.
- Background: PubMed 15817755Ravn 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.
- Background: PubMed 11696195Brusasca 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.
- Background: PubMed 18431468Weldingh 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.
- Background: PubMed 17005738Aagaard 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.
- Derived from this study: PubMed 34021314Xu M, Lu W, Li T, Li J, Du W, Wu Q, Liu Q, Yuan B, Lu J, Ding X, Li F, Liu M, Chen B, Pu J, Zhang R, Xi X, Zhou R, Mei Z, Du R, Tao L, Martinez L, Lu S, Wang G, Zhu F. Sensitivity, Specificity, and Safety of a Novel ESAT6-CFP10 Skin Test for Tuberculosis Infection in China: 2 Randomized, Self-Controlled, Parallel-Group Phase 2b Trials. Clin Infect Dis. 2022 Mar 1;74(4):668-677. doi: 10.1093/cid/ciab472.
- Center for drug evaluation,China Food and Drug Administration(CFDA) ,ChinaLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Lu, Master principal investigator
Jingsu Province Centers for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 5μg/ml ESAT6-CFP10, 10μg/ml ESAT6-CFP10 and BCG in people with Tuberculosis, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 1 site in China.
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 19 inclusion and 0 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 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
immune response of ESAT6-CFP10 from the size of induration or redness in all population (time frame: within 72 Hours After Intradermal Injection With ESAT6-CFP10). The study lists 3 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 NCT02389322, which also lists 6 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 17 Mar 2017.