TuberculosisPhase 2NCT06305104
Clinical Trial to Explore the Skin Test Dosage of EEC in People Aged 18 to 65 Years Old and the Safety and Preliminary Efficacy in People Aged 3 to 75 Years Old.
A Phase 2 study testing 2.5μg/ml EEC, 5μg/ml EEC and 5 unit（U） EC in people with Tuberculosis, run by Chengdu CoenBiotech Co., Ltd at 6 sites in China.
Trial summary
This is a randomized, blind, positive-controlled study to explore the skin test dosage of recombinant mycobacterium tuberculosis fusion protein ( EEC) in the population aged 18 to 65 years old , and to further evaluate the safety and preliminary efficacy of EEC in the population aged 3 to 75 years old. Read more about this study
- Who is it for?
- Ages 3 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- 2.5μg/ml EEC, 5μg/ml EEC and 5 unit（U） EC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 6 sitesChina
- Study dates
- 18 Jul 2023to 30 Jun 2024
- 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 3 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- For healthy subjects:
- At the time of enrollment - For healthy subjects:enrollment is 3 ~ 75 years old (including 3 years old and 75 years old), regardless of gender ;
- Guardians of persons aged 3-7 years , persons aged 8-17 years old and their guardians, persons aged 18-75 years old themselves and/or their guardians (spouse or children) agree to participate in this trial and sign an informed consent form;
- The person and/or guardian can comply with the requirements of the clinical trial protocol to participate in /accompany the subject to follow- up visits;
- After medical history inquiry, there is no history of tuberculosis (including intrapulmonary and external tuberculosis ) and close contact history with tuberculosis patients (referring to direct contact with registered tuberculosis patients from 3 months before diagnosis to 14 days after starting anti-tuberculosis treatment);
- Those who have no clinical symptoms of tuberculosis poisoning and whose chest imaging examination (for subjects aged 15 to 75 years old) is normal or abnormal without clinical significance;
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- Normal or abnormal measurements of vital signs ( axillary temperature, pulse , respiration , blood pressure ) and electrocardiogram have no clinical significance; [ The axillary temperature of all subjects was measured < 37.3°C ; blood pressure was measured in subjects aged 18-75 years (systolic blood pressure <160 millimetres of mercury（mmHg） and diastolic blood pressure <100mmHg) ; pulse and respiration were determined by the researcher based on the subject's age]
- Physical examinations are normal or abnormal with no clinical significance;
- Laboratory tests including blood routine, urine routine, and blood biochemistry tests were all normal or abnormal with no clinical significance.
- For patients with tuberculosis (including pulmonary tuberculosis):
- Those who was diagnosed with tuberculosis/ pulmonary tuberculosis according to the "People's Republic of China Health Industry Standard Pulmonary Tuberculosis Diagnostic Criteria " combined with the "Technical Guidelines for Tuberculosis Prevention and Control in China ( 2021 Edition )" (accepted clinical comprehensive analysis diagnosis);
- The age at the time of enrollment is 3 to 75 years old (including 3 years old and 75 years old), regardless of gender ;
- Guardians of persons aged 3-7 years old, persons aged 8-17 years old and their guardians, persons aged 18-75 years old themselves and/ or their guardians (spouse or children) agree to participate in this trial and sign an informed consent form;
- The person and /or guardian may comply with the requirements of the clinical trial protocol and participate in follow-up visits.
- For patients with non-tuberculous lung disease
- Patients with clear clinical diagnosis of pulmonary disease, and the clinician can rule out pulmonary tuberculosis and extrapulmonary tuberculosis based on the patient's clinical manifestations, imaging and laboratory tests (including IGRA );
- Age at the time of enrollment is 18 to 65 years old (including 18 years old and 65 years old), regardless of gender;
- Those who agree to participate in this trial and sign the informed consent form;
- Those who may comply with the requirements of the clinical trial protocol and participate in follow-up visits
Who cannot join
- Those with known or suspected (or high-risk) severe immune diseases, immune function impairment or abnormalities ( except HIV infection /AIDS ), including:
- who have convulsions, epilepsy, a history of mental illness and / or a family history of mental illness (immediate relatives);
- People with allergies, such as those who have a history of allergies to two or more drugs or foods, or those who are known to be allergic to the components of this medicine;
- Those currently suffering from acute infectious diseases (such as measles, whooping cough, influenza, etc.), acute conjunctivitis, acute otitis media, and generalized skin diseases;
- After consultation, have a history of past or current serious heart, liver, kidney, digestive system, respiratory system, nervous system, mental disorder and metabolic disorders;
- Those who are currently suffering from acute febrile illness; or those who have used antipyretic, analgesic and anti-allergic drugs within 3 days before the skin test and which may affect the research evaluation as assessed by the researcher ;
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- People with serious infections (such as pyoderma, severe eczema, etc.);
- who are participating in or participating in any other new drug clinical trials within 3 months;
- Have received non-live vaccines within 7 days before the skin test , or have received live attenuated vaccines within 28 days ;
- Lactating or pregnant women, or female subjects of childbearing age who have a positive pregnancy test before enrollment and who have not taken effective contraceptive measures 2 weeks before enrollment.
- Those with a history of drug abuse;
- Any other circumstances that the investigator believes may affect the evaluation of the study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Beijing Chest Hospital
Beijing, Beijing Municipality, 101149
Tongqun Zhang, 010-89509134, Zhangtongqun@sina.com
Naihui Chu, PhD
- Recruiting
Changde First People's Hospital
Changde, Hunan, 415000
Shuxiang Zhou, 0736-7788890, 450717196@qq.com
Tianli Wang, master
- Recruiting
Public health clinical center of chengdu
Chengdu, Sichuan, 610066
Qing Yang, 028-64369118, crbykjk@126.com
Guihui Wu, master
- Recruiting
Jiangsu Province Centers for Disease Control and Prevention
Nanjing, Jiangsu, 212400
Xiaoyan Ding, 025-83759406, ec@jscdc.cn
Limei Zhu, master
- Recruiting
Wuhan Institute for Tuberculosis Control
Wuhan, Hubei, 430000
Min Wang, 13871221841, whsfkyyllsc@163.com
Juan Du, Bachelor
- Recruiting
Xuzhou Infectious Disease Hospital
Xuzhou, Jiangsu
Tingting Liu, 0516-68900929, xcyllb123@163.com
Ruimei Zhang, Bachelor
About this study
Official title: Phase 2 Clinical Trial of Randomized, Blinded, Positive-controlled to Explore the Skin Test Dosage of EEC in People Aged 18 to 65 Years Old and the Safety and Preliminary Efficacy in People Aged 3 to 75 Years Old.
This is a randomized, blind, positive-controlled study to explore the skin test dosage of recombinant mycobacterium tuberculosis fusion protein ( EEC) in the population aged 18 to 65 years old , and to further evaluate the safety and preliminary efficacy of EEC in the population aged 3 to 75 years old.
In the first stage,180 healthy subjects, 140 tuberculosis（TB）subjects and 40 non-TB subjects with lung diseases aged 18 to 65 years old are divided into different groups through a randomized, blind methods. Every group carry out a low-dose (2.5μg/ml) or high-dose (5μg/ml) study, with 180 subjects in each dose group .Every subject injects intradermally EEC and EC randomly in both arms of the same person. Evaluate the consistency of assay results of EEC, EC and Interferon-Gamma Release Assay（IGRA）.Evaluate the sensitivity, specificity and consistency of assay results of EEC, EC and IGRA in healthy people, TB patients and non-TB patients with lung diseases, and determine the optimal dose of EEC for clinical auxiliary diagnosis of tuberculosis.
In the second stage, 60 healthy subjects and TB subjects aged 3-17 years and 66-75 years old are divided into different groups through a randomized, open, single-arm method with the target dose. Evaluate the safety, tolerance and preliminary efficacy of target dose of EEC in healthy people and TB patients aged 3 to 17 years old and 66 to 75 years old.
Read the detailed description
In the first stage,180 healthy subjects, 140 TB subjects and 40 non-TB subjects with lung diseases which meet the standard respectively are divided into different groups through a randomized blind methods.Every group carry out a low-dose (2.5μg/ml) or high-dose (5μg/ml) study, with 180 subjects in each dose group.
Each subject's left and right arms will be randomly assigned to receive an intradermal injection of the experimental drug EEC and the control drug inoculated in both arms of the same person. A drug(EEC or EC) is injected in left arm first, observe 30 min and if no obvious adverse reaction ,then another drug (EEC or EC) will be injected in right arm. Observe and record the vital signs (breathing, heart rate, blood pressure ,temperature),the skin specific reaction (diameters of flush and induration of injection site) at 24h, 48h, 72h, 96h, and 7 days after skin test;local reactions (redness, pain, swelling, rash,itching) and a variety of adverse events. Evaluate the sensitivity , specificity and consistency rate of assay results of EEC, EC and IGRA in healthy subjects, TB patients and non-TB patients with lung diseases,determine the optimal dose of EEC for clinical auxiliary diagnosis of tuberculosis,and further evaluate the safety of EEC in healthy subjects, TB patients and non-TB patients with lung diseases.
In the second stage, 60 subjects aged 3-17 years old (30 cases) and 66-75 years old (30 cases) are enrolled, including 30 healthy subjects and 30 TB patients. Every subject is divided into different groups through a randomized, open label method, and receive a single intradermal injection of experimental drug (EEC) in one arm. Observe and record the vital signs (breathing, heart rate and temperature); laboratory examination and electrocardiogram (ECG) ;the skin specific reactions of injection site at 4h,8h,24h, 48h, 72h, 96h, and 7 days after skin test ; local reactions and a variety of adverse events，to further evaluate the safety and preliminary efficacy of EEC in people aged 3 to 75 years old.
- Conditions
- Tuberculosis
- Being tested
- 2.5μg/ml EEC, 5μg/ml EEC, 5 unit（U） EC
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2.5μg/ml EECBiological
0.1ml ,one time, containing low dose of 2.5μg/ml of active ingredients
5μg/ml EECBiological
0.1ml, one time, containing high dose 5μg/ml of active ingredients
5 unit（U） ECBiological
0.1 ml , one time, containing 5U of active ingredients
| Study group | Role | What they receive |
|---|---|---|
| TB subjects in 18-65 years old | Experimental | 140 TB subjects's left and right arms were randomly assigned to receive a single intradermal injection of 0.1 ml of the test drug (EEC,2.5 μg /ml or 5 μg /ml ) and the control drug (inoculated in both arms of the same body); all subjects were intradermally injected into the middle and lower 1/3 of the volar side of the forearm using the Mantoux method. injection. The time between skin tests on the left and right arms must be at least 30 minutes (skin test on the left arm first, then on the right arm). The follow-up visit observation point is based on the completion time of the second dose of injection. Receives: Biological: 2.5μg/ml EEC; Biological: 5μg/ml EEC; Biological: 5 unit（U） EC |
| healthy subjects in 18-65 years old | Experimental | 180 healthy subjects's left and right arms were randomly assigned to receive a single intradermal injection of 0.1 ml of the test drug (EEC,2.5 μg /ml or 5 μg /ml ) and the control drug (inoculated in both arms of the same body); all subjects were intradermally injected into the middle and lower 1/3 of the volar side of the forearm using the Mantoux method. injection. The time between skin tests on the left and right arms must be at least 30 minutes (skin test on the left arm first, then on the right arm). The follow-up visit observation point is based on the completion time of the second dose of injection. Receives: Biological: 2.5μg/ml EEC; Biological: 5μg/ml EEC; Biological: 5 unit（U） EC |
| non-TB subjects with lung disease in 18-65 years old | Experimental | 40 non-TB subjects with lung disease in 18-65 years old,each subject's left and right arms were randomly assigned to receive a single intradermal injection of 0.1 ml of the test drug (EEC,2.5 μg /ml or 5 μg /ml ) and the control drug (inoculated in both arms of the same body); all subjects were intradermally injected into the middle and lower 1/3 of the volar side of the forearm using the Mantoux method. injection. The time between skin tests on the left and right arms must be at least 30 minutes (skin test on the left arm first, then on the right arm). The follow-up visit observation point is based on the completion time of the second dose of injection. Receives: Biological: 2.5μg/ml EEC; Biological: 5μg/ml EEC; Biological: 5 unit（U） EC |
| TB subjects in 3-17 years old and 66-75 years old | Experimental | Each enrolled subject received a single intradermal injection of 0.1 ml of the test drug (EEC) in one arm; the Mantoux method was used to inject intradermally into the middle and lower 1/3 of the volar side of the forearm. Receives: Biological: 5μg/ml EEC |
| non-TB subjects in 3-17 years old and 66-75 years old | Experimental | Each enrolled subject received a single intradermal injection of 0.1 ml of the test drug (EEC) in one arm; the Mantoux method was used to inject intradermally into the middle and lower 1/3 of the volar side of the forearm. Receives: Biological: 5μg/ml EEC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of different doses of EEC and control EC in pulmonary tuberculosis patients aged 18 to 65 years ;
Sensitivity (also known as the true positive rate which is defined as the percentage of actual disease that is correctly judged to be diseased according to the diagnostic criteria of the test)of different doses of EEC and control EC in patients with pulmonary tuberculosis aged 18 to 65 years old.
Measured: 7days after injection
specificity of different doses of EEC and control EC in healthy subjects aged 18 to 65 years and patients with non-tuberculous lung disease ;
Specificity (also known as true negative rate which is defined as the percentage of actual disease-free patients correctly judged to be disease-free according to the diagnostic criteria of the test) of different doses of EEC and control EC in healthy people and patients with non-tuberculous lung disease aged 18 to 65 years old.
Measured: 7days after injection
The skin test site specific reaction at 4h,8h (only for stage 2);24h, 48h, 72h, 96h, and 7 days after skin test. Those with average diameter of induration/redness is ≥5 mm will be considered to positive.
Endpoint of skin test site specific response evaluation which is defined as the skin test site symptom at 4 hour(only for stage 2), 8 hour(only for stage 2）, 24 hour ,48 hour,72 hour,96 hour and 7 days after the skin test such as redness, induration, double ring, blister, necrosis, and lymphangitis (any symptoms of double ring, blister, necrosis, and lymphangitis were strongly positive).
Measured: 7days after injection
Secondary outcomes (4)
Receiver operator characteristic curve(ROC) of different doses of EEC to evaluate the optimal diagnostic test cut-off value of the test drug.
Measured: 7days after injection
Area under the curve(AUC) of different doses of EEC to evaluate the optimal diagnostic test cut-off value of the test drug.
Measured: 7days after injection
In healthy people, patients with tuberculosis and patients with non-tuberculous lung diseases, the consistency rates of the three detection reagents EEC , EC and IGRA were evaluated respectively.
The consistency rate of EC, EEC and IGRA detection reagents which is defined as the pairwise KAPPA values of the three detection methods in different dose groups among healthy people, patients with pulmonary tuberculosis and patients with non-tuberculosis pulmonary disease( the Kappa values of the three detection methods in different dose groups were calculated respectively ).
Measured: 7days after injection
Incidence of adverse events and serious adverse events at injection and non-injection sites，abnormal incidence of laboratory indicators and vital signs during the study period.
Safety endpoint including: incidence of adverse events at injection and non-injection sites within 7 days after skin test; abnormal incidence of laboratory indicators (blood routine, blood biochemistry, urine routine, ECG test) at 72 hour after skin test; abnormal incidence of vital signs within 7 days after skin test; incidence of serious adverse events after skin test during the study period.
Measured: 7days after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start18 Jul 2023
- Primary completion30 May 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu CoenBiotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Chest Hospital, Capital Medical University, Wuhan Institute for Tuberculosis Control, Chengdu Public Health Clinical Center, Xuzhou Infectious Disease Hospital, Jiangsu Province Centers for Disease Control and Prevention, Changde First People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06305104
- Sponsor's protocol ID
- KN-EEC-II
- Status last verified
- Feb 2024
- First submitted
- 16 Jan 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Clinical Trial of Randomized, Blinded, Positive-controlled to Explore the Skin Test Dosage of EEC in People Aged 18 to 65 Years Old and the Safety and Preliminary Efficacy in People Aged 3 to 75 Years Old.
- ClinicalTrials.gov ID
- NCT06305104
- Acronym / sponsor ID
- KN-EEC-II
- Conditions
- Tuberculosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Chengdu CoenBiotech Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Beijing Chest Hospital, Capital Medical University, Wuhan Institute for Tuberculosis Control, Chengdu Public Health Clinical Center, Xuzhou Infectious Disease Hospital, Jiangsu Province Centers for Disease Control and Prevention, Changde First People's Hospital
- Study start
- 18 Jul 2023 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 12 Mar 2024 (actual)
- 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.
This is a randomized, blind, positive-controlled study to explore the skin test dosage of recombinant mycobacterium tuberculosis fusion protein ( EEC) in the population aged 18 to 65 years old , and to further evaluate the safety and preliminary efficacy of EEC in the population aged 3 to 75 years old.
In the first stage,180 healthy subjects, 140 tuberculosis（TB）subjects and 40 non-TB subjects with lung diseases aged 18 to 65 years old are divided into different groups through a randomized, blind methods. Every group carry out a low-dose (2.5μg/ml) or high-dose (5μg/ml) study, with 180 subjects in each dose group .Every subject injects intradermally EEC and EC randomly in both arms of the same person. Evaluate the consistency of assay results of EEC, EC and Interferon-Gamma Release Assay（IGRA）.Evaluate the sensitivity, specificity and consistency of assay results of EEC, EC and IGRA in healthy people, TB patients and non-TB patients with lung diseases, and determine the optimal dose of EEC for clinical auxiliary diagnosis of tuberculosis.
In the second stage, 60 healthy subjects and TB subjects aged 3-17 years and 66-75 years old are divided into different groups through a randomized, open, single-arm method with the target dose. Evaluate the safety, tolerance and preliminary efficacy of target dose of EEC in healthy people and TB patients aged 3 to 17 years old and 66 to 75 years old.
Detailed description
In the first stage,180 healthy subjects, 140 TB subjects and 40 non-TB subjects with lung diseases which meet the standard respectively are divided into different groups through a randomized blind methods.Every group carry out a low-dose (2.5μg/ml) or high-dose (5μg/ml) study, with 180 subjects in each dose group.
Each subject's left and right arms will be randomly assigned to receive an intradermal injection of the experimental drug EEC and the control drug inoculated in both arms of the same person. A drug(EEC or EC) is injected in left arm first, observe 30 min and if no obvious adverse reaction ,then another drug (EEC or EC) will be injected in right arm. Observe and record the vital signs (breathing, heart rate, blood pressure ,temperature),the skin specific reaction (diameters of flush and induration of injection site) at 24h, 48h, 72h, 96h, and 7 days after skin test;local reactions (redness, pain, swelling, rash,itching) and a variety of adverse events. Evaluate the sensitivity , specificity and consistency rate of assay results of EEC, EC and IGRA in healthy subjects, TB patients and non-TB patients with lung diseases,determine the optimal dose of EEC for clinical auxiliary diagnosis of tuberculosis,and further evaluate the safety of EEC in healthy subjects, TB patients and non-TB patients with lung diseases.
In the second stage, 60 subjects aged 3-17 years old (30 cases) and 66-75 years old (30 cases) are enrolled, including 30 healthy subjects and 30 TB patients. Every subject is divided into different groups through a randomized, open label method, and receive a single intradermal injection of experimental drug (EEC) in one arm. Observe and record the vital signs (breathing, heart rate and temperature); laboratory examination and electrocardiogram (ECG) ;the skin specific reactions of injection site at 4h,8h,24h, 48h, 72h, 96h, and 7 days after skin test ; local reactions and a variety of adverse events，to further evaluate the safety and preliminary efficacy of EEC in people aged 3 to 75 years old.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| TB subjects in 18-65 years old | Experimental | Biological: 2.5μg/ml EEC, Biological: 5μg/ml EEC, Biological: 5 unit（U） EC140 TB subjects's left and right arms were randomly assigned to receive a single intradermal injection of 0.1 ml of the test drug (EEC,2.5 μg /ml or 5 μg /ml ) and the control drug (inoculated in both arms of the same body); all subjects were intradermally injected into the middle and lower 1/3 of the volar side of the forearm using the Mantoux method. injection. The time between skin tests on the left and right arms must be at least 30 minutes (skin test on the left arm first, then on the right arm). The follow-up visit observation point is based on the completion time of the second dose of injection. |
| healthy subjects in 18-65 years old | Experimental | Biological: 2.5μg/ml EEC, Biological: 5μg/ml EEC, Biological: 5 unit（U） EC180 healthy subjects's left and right arms were randomly assigned to receive a single intradermal injection of 0.1 ml of the test drug (EEC,2.5 μg /ml or 5 μg /ml ) and the control drug (inoculated in both arms of the same body); all subjects were intradermally injected into the middle and lower 1/3 of the volar side of the forearm using the Mantoux method. injection. The time between skin tests on the left and right arms must be at least 30 minutes (skin test on the left arm first, then on the right arm). The follow-up visit observation point is based on the completion time of the second dose of injection. |
| non-TB subjects with lung disease in 18-65 years old | Experimental | Biological: 2.5μg/ml EEC, Biological: 5μg/ml EEC, Biological: 5 unit（U） EC40 non-TB subjects with lung disease in 18-65 years old,each subject's left and right arms were randomly assigned to receive a single intradermal injection of 0.1 ml of the test drug (EEC,2.5 μg /ml or 5 μg /ml ) and the control drug (inoculated in both arms of the same body); all subjects were intradermally injected into the middle and lower 1/3 of the volar side of the forearm using the Mantoux method. injection. The time between skin tests on the left and right arms must be at least 30 minutes (skin test on the left arm first, then on the right arm). The follow-up visit observation point is based on the completion time of the second dose of injection. |
| TB subjects in 3-17 years old and 66-75 years old | Experimental | Biological: 5μg/ml EECEach enrolled subject received a single intradermal injection of 0.1 ml of the test drug (EEC) in one arm; the Mantoux method was used to inject intradermally into the middle and lower 1/3 of the volar side of the forearm. |
| non-TB subjects in 3-17 years old and 66-75 years old | Experimental | Biological: 5μg/ml EECEach enrolled subject received a single intradermal injection of 0.1 ml of the test drug (EEC) in one arm; the Mantoux method was used to inject intradermally into the middle and lower 1/3 of the volar side of the forearm. |
Who may qualify
- Ages
- 3 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (19 listed)
- For healthy subjects:
- For patients with tuberculosis (including pulmonary tuberculosis):
- For patients with non-tuberculous lung disease
Key exclusion criteria (12 listed)
- Those with known or suspected (or high-risk) severe immune diseases, immune function impairment or abnormalities ( except HIV infection /AIDS ), including:
- who have convulsions, epilepsy, a history of mental illness and / or a family history of mental illness (immediate relatives);
- People with allergies, such as those who have a history of allergies to two or more drugs or foods, or those who are known to be allergic to the components of this medicine;
- Those currently suffering from acute infectious diseases (such as measles, whooping cough, influenza, etc.), acute conjunctivitis, acute otitis media, and generalized skin diseases;
- After consultation, have a history of past or current serious heart, liver, kidney, digestive system, respiratory system, nervous system, mental disorder and metabolic disorders;
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 |
|---|---|---|
| 2.5μg/ml EEC0.1ml ,one time, containing low dose of 2.5μg/ml of active ingredients | Biological | TB subjects in 18-65 years old, healthy subjects in 18-65 years old, non-TB subjects with lung disease in 18-65 years old |
| 5μg/ml EEC0.1ml, one time, containing high dose 5μg/ml of active ingredients | Biological | TB subjects in 18-65 years old, TB subjects in 3-17 years old and 66-75 years old, healthy subjects in 18-65 years old, non-TB subjects in 3-17 years old and 66-75 years old, non-TB subjects with lung disease in 18-65 years old |
| 5 unit（U） EC0.1 ml , one time, containing 5U of active ingredients | Biological | TB subjects in 18-65 years old, healthy subjects in 18-65 years old, non-TB subjects with lung disease in 18-65 years old |
Primary outcome
Sensitivity of different doses of EEC and control EC in pulmonary tuberculosis patients aged 18 to 65 years ;
Time frame: 7days after injection
Sensitivity (also known as the true positive rate which is defined as the percentage of actual disease that is correctly judged to be diseased according to the diagnostic criteria of the test)of different doses of EEC and control EC in patients with pulmonary tuberculosis aged 18 to 65 years old.
specificity of different doses of EEC and control EC in healthy subjects aged 18 to 65 years and patients with non-tuberculous lung disease ;
Time frame: 7days after injection
Specificity (also known as true negative rate which is defined as the percentage of actual disease-free patients correctly judged to be disease-free according to the diagnostic criteria of the test) of different doses of EEC and control EC in healthy people and patients with non-tuberculous lung disease aged 18 to 65 years old.
The skin test site specific reaction at 4h,8h (only for stage 2);24h, 48h, 72h, 96h, and 7 days after skin test. Those with average diameter of induration/redness is ≥5 mm will be considered to positive.
Time frame: 7days after injection
Endpoint of skin test site specific response evaluation which is defined as the skin test site symptom at 4 hour(only for stage 2), 8 hour(only for stage 2）, 24 hour ,48 hour,72 hour,96 hour and 7 days after the skin test such as redness, induration, double ring, blister, necrosis, and lymphangitis (any symptoms of double ring, blister, necrosis, and lymphangitis were strongly positive).
4 secondary outcomes
Receiver operator characteristic curve(ROC) of different doses of EEC to evaluate the optimal diagnostic test cut-off value of the test drug.
Time frame: 7days after injection
Area under the curve(AUC) of different doses of EEC to evaluate the optimal diagnostic test cut-off value of the test drug.
Time frame: 7days after injection
In healthy people, patients with tuberculosis and patients with non-tuberculous lung diseases, the consistency rates of the three detection reagents EEC , EC and IGRA were evaluated respectively.
Time frame: 7days after injection
Incidence of adverse events and serious adverse events at injection and non-injection sites，abnormal incidence of laboratory indicators and vital signs during the study period.
Time frame: 7days after injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: Undecided
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Tuberculosis, MDR
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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 2.5μg/ml EEC, 5μg/ml EEC and 5 unit（U） EC in people with Tuberculosis, run by Chengdu CoenBiotech Co., Ltd at 6 sites 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 12 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: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naihui Chu, PhD (13611326573, dongchu1994@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of different doses of EEC and control EC in pulmonary tuberculosis patients aged 18 to 65 years ; (time frame: 7days after injection). 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?
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 12 Mar 2024.