HealthyPhase 1NCT01999231
Phase I Clinical Human Tolerability Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10
A Phase 1 study testing ESAT6-CFP10 in people with Healthy, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd..
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ESAT6-CFP10
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Dec 2013
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged from 18 to 40 years old, age difference is not more than 10 years old within the same batch of healthy volunteers, the male to female ratio of cases is 1:1. Body mass index should be in the range of 20 to 27 Body Mass Index BMI: weight (Kg)/ height (M2);
- Agreed to participate in the test and sign the informed consent;
- Subjects should comply with the requirements of the clinical trial protocol and be followed;
- Subjects have no history of TB (Tuberculosis)or family history of tuberculosis;
- People have no pulmonary tuberculosis or extrapulmonary tuberculosis,respiratory symptom or systemic symptoms;
- People have no tuberculosis focus after examination by X-ray chest radiograph and sputum bacilli;
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- Subjects have no acute or chronic disease, acute infectious diseases, dermatoses or skin allergy caused by various reasons;
- Physical condition: have no history of heart, liver, kidney, gastrointestinal tract, nervous system, or metabolic disturbance, etc. ECG, blood pressure, heart rate, respiratory status and lab test indexes including blood, urine, liver and kidney function, etc are all normal within 4 weeks before screening;
- No close contacts of tuberculosis;
- Subjects have not participated in other clinical drug trials or inoculated against other prophylactic and immune globulin in the nearly 3 months;
- Temperature is normal;
- Stop smoking, drinking and drinking contains caffeinated.
Who cannot join
- Health people have close contacts of TB (Tuberculosis)patients, especially excreter in 3 weeks before selection;
- Suffering from any other serious disease, e.g. during cancer treatment, autoimmune disease, progressive atherosclerosis, diabetes accompanied with complications, chronic obstructive pulmonary disease (COPD) needing oxygen therapy, acute or progressive liver or kidney disease, congestive heart failure, etc.;
- People have history of allergy, convulsions, epilepsy, cerebropathy, neurological symptoms and signs;
- Patients who have impaired or abnormal immune function, e.g. patients treated with immunosuppressor or immunopotentiator, received immunoglobulin preparation or blood products or plasma extraction outside the gastrointestinal tract in 3 months, human immunodeficiency virus or related diseases;
- Acute febrile illness and infection;
- Taking part in other clinic trials;
Show all 13Show fewer
- Subjects have participated in any other clinical drug trials in 3 months before our clinical tests;
- Allergic constitution, e.g. patients have allergic history to two or more kinds of drugs or food, or drug components;
- Substance abuse and alcoholics ;
- Pregnant or breast feeding women;
- Mental or physical disability;
- Informed leavers;
- Any other cases that may influence the test evaluation.
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Healthy
- Being tested
- ESAT6-CFP10
- Keywords
- Safety, Tolerability, ESAT6, CFP10, skin test, diagnostic test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESAT6-CFP10Biological
Also called Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10, EC
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 .
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: ESAT6-CFP10 |
| 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. Receives: Biological: ESAT6-CFP10 |
| 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. Receives: Biological: ESAT6-CFP10 |
| 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. Receives: Biological: ESAT6-CFP10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: within 7 days after the injections
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 96h after application of ESAT6-CFP10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2013 (estimated)
- Study startSep 2013
- Primary completionOct 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Public Health Clinical Center, Air Force Military Medical University, China, Proswell Medical Corporation
- Responsible party
- Sponsor
- Investigators
- Shuihua Lu, Bachelor, Principal investigator, Shanghai Public Health Clinical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01999231
- Sponsor's protocol ID
- LTao-EC
- Other IDs
- LTao
- Status last verified
- Mar 2015
- First submitted
- 4 Nov 2013
- Last updated
- 31 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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 17005738Li 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.
PubMed 27413070
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Human Tolerability Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10
- ClinicalTrials.gov ID
- NCT01999231
- Acronym / sponsor ID
- LTao-EC
- Conditions
- Healthy
- Keywords
- Safety, Tolerability, ESAT6, CFP10, skin test, diagnostic test
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Public Health Clinical Center, Air Force Military Medical University, China, Proswell Medical Corporation
- Study start
- Sep 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 3 Dec 2013 (estimated)
- Results
- Posted 31 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1μg/ml ESAT6-CFP10 | Experimental | Biological: ESAT6-CFP10The 1μg/ml ESAT6-CFP10 is given 0.1ml alone to volunteers in the RIGHT or LEFT forearm according to a randomisation scheme. |
| 5μg/ml ESAT6-CFP10 | Experimental | Biological: ESAT6-CFP10The 5μg/ml ESAT6-CFP10 is given 0.1ml alone to volunteers in the RIGHT or LEFT forearm according to a randomisation scheme. |
| 10μg/ml ESAT6-CFP10 | Experimental | Biological: ESAT6-CFP10The 10μg/ml ESAT6-CFP10 is given 0.1ml alone to volunteers in the RIGHT or LEFT forearm according to a randomisation scheme. |
| 20μg/ml ESAT6-CFP10 | Experimental | Biological: ESAT6-CFP10The 20μg/ml ESAT6-CFP10 is given 0.1ml alone to volunteers in the RIGHT or LEFT forearm according to a randomisation scheme. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Aged from 18 to 40 years old, age difference is not more than 10 years old within the same batch of healthy volunteers, the male to female ratio of cases is 1:1. Body mass index should be in the range of 20 to 27 Body Mass Index BMI: weight (Kg)/ height (M2);
- Agreed to participate in the test and sign the informed consent;
- Subjects should comply with the requirements of the clinical trial protocol and be followed;
- Subjects have no history of TB (Tuberculosis)or family history of tuberculosis;
- People have no pulmonary tuberculosis or extrapulmonary tuberculosis,respiratory symptom or systemic symptoms;
Key exclusion criteria (13 listed)
- Health people have close contacts of TB (Tuberculosis)patients, especially excreter in 3 weeks before selection;
- Suffering from any other serious disease, e.g. during cancer treatment, autoimmune disease, progressive atherosclerosis, diabetes accompanied with complications, chronic obstructive pulmonary disease (COPD) needing oxygen therapy, acute or progressive liver or kidney disease, congestive heart failure, etc.;
- People have history of allergy, convulsions, epilepsy, cerebropathy, neurological symptoms and signs;
- Patients who have impaired or abnormal immune function, e.g. patients treated with immunosuppressor or immunopotentiator, received immunoglobulin preparation or blood products or plasma extraction outside the gastrointestinal tract in 3 months, human immunodeficiency virus or related diseases;
- Acute febrile illness and infection;
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 |
|---|---|---|
| ESAT6-CFP10Also: Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10, EC32 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 . | Biological | 10μg/ml ESAT6-CFP10, 1μg/ml ESAT6-CFP10, 20μg/ml ESAT6-CFP10, 5μg/ml ESAT6-CFP10 |
Primary outcome
the Cases of Adverse Events With Participant Injection of ESAT6-CFP10
Time frame: within 7 days after the injections
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 .
5 secondary outcomes
the Number of Participants Who Appear the Induration and/or Redness 2h After Application of ESAT6-CFP10
Time frame: within 2h after application of ESAT6-CFP10
the Number of Participants Who Appear the Induration and/or Redness 24h After Application of ESAT6-CFP10
Time frame: 24h after application of ESAT6-CFP10
the Number of Participants Who Appear the Induration and/or Redness 48h After Application of ESAT6-CFP10
Time frame: 48h after application of ESAT6-CFP10
the Number of Participants Who Appear the Induration and/or Redness 72h After Application of ESAT6-CFP10
Time frame: 72h after application of ESAT6-CFP10
the Number of Participants Who Appear the Induration and/or Redness 96h After Application of ESAT6-CFP10
Time frame: 96h after application of ESAT6-CFP10
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 27413070Li 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.
- Center for drug evaluation, CFDA ,ChinaLink provided by the sponsor.
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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.
Shuihua Lu, Bachelor principal investigator
Shanghai Public Health Clinical Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ESAT6-CFP10 in people with Healthy, 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 12 inclusion and 13 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 31 Mar 2015. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
the Cases of Adverse Events With Participant Injection of ESAT6-CFP10 (time frame: within 7 days after the injections). 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 NCT01999231, 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 31 Mar 2015.