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CompletedNCT02329730Updated Apr 9, 2015Results posted

Phase IIa Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10

A Phase 2 interventional study of 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative and 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative in Tuberculosis, sponsored by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.. Completed. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-09.

Sponsored by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. · Phase 2, Interventional, and Diagnostic

Phase
Phase 2
Study type
Interventional
Enrollment
144
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Choose healthy subjects and patients with TB, distribute them into different dose groups according to the recombinant EC allergen dose from low to high average. Conducting clinical trials of TB-PPD or placebo as controlled arms intradermal injection. Do specific interferon gamma detection before the skin test，after the test 72h±2h and 144h±2h. Evaluate the safety of the recombinant EC allergy , and provide the appropriate dose range for phase IIb clinical trials.

Read the detailed description

First, 56 healthy subjects are distributed into different dose groups according to the recombinant EC allergen dose from low to high.Conducting clinical trials of TB-PPD as controlled arms intradermal injection.Do specific interferon gamma detection before the skin test，after the test 72h±2h and 144h±2h. The vital signs (breathing, heart rate, blood pressure and temperature), skin reaction at injection site (flush and induration) , local reactions (rash, pain, itching and skin mucous membrane) and a variety of adverse events; The vital signs, blood routine, urine routine, liver and kidney function, electrocardiogram （before the skin test,after skin test 144h ）are the main test items,Evaluate the safety of the recombinant EC allergy in the expansion of the healthy people , and provide the appropriate dose range for phase IIb clinical trials.

Second，56 patients of TB are distributed different dose groups according to the recombinant EC allergen dose from low to high. Conducting clinical trials of TB-PPD as controlled arms intradermal injection.Do specific interferon gamma detection before the skin test，after the test 72h±2h and 144h±2h. The vital signs (breathing, heart rate, blood pressure and temperature),skin reaction at injection site (flush and induration) , local reactions (rash, pain, itching and skin mucous membrane) and a variety of adverse events; The vital signs, blood routine, urine routine, liver and kidney function, electrocardiogram （before the skin test,after skin test 144h ）are the main test items,Evaluate the safety of the recombinant EC allergy in patients of TB,and provide the appropriate dose range for phase IIb clinical trials.

Third，32 patients of TB are distributed into different dose groups according to the recombinant EC allergen dose from low to high. Conducting clinical trials of placebo as controlled arms intradermal injection.Do specific interferon gamma detection before the skin test，after the test 72h±2h and 144h±2h. The vital signs (breathing, heart rate, blood pressure and temperature), skin reaction at injection site (flush and induration), local reactions (rash, pain, itching and skin mucous membrane) and a variety of adverse events; The vital signs, blood routine, urine routine, liver and kidney function, electrocardiogram （before the skin test,after skin test 144h ）are the main test items,Evaluate the safety of the recombinant EC allergy in patients of TB on safety.

02

Conditions studied

  • Tuberculosis

Browse trials for

Keywords

  • diagnosis of Tuberculosis (TB)
  • ESAT6
  • CFP10
  • Phase IIa Clinical Trial
03

In context

Tuberculosis

1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.

This study's enrollment of 144 is close to the median of 150 across 952 interventional studies indexed under Tuberculosis.

Browse Tuberculosis studies →

Lead sponsor

Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. is the lead sponsor of 45 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria of healthy subjects:

  1. 18 to 65 years old
  2. Consent and signed ICF(informed consent forms)
  3. Comply with follow-up
  4. No history or family history of TB(tuberculosis)
  5. Without the internal and external of pulmonary tuberculosis ; no symptoms of respiratory tract and other body parts for TB
  6. The examination such as X-ray chest radiograph, sputum bacteria confirmed non-tuberculosis (TB)
  7. No uncontrolled kinds of acute or chronic disease or acute infectious diseases or skin disease or skin allergies due to a variety of causes
  8. 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
  9. Did not attend any other new drug clinical trials and not vaccinate prevention products and immunoglobulin for nearly 3 months
  10. Normal axillary temperature(quiet condition ≤37.0 ℃)
  11. No smoking, no alcohol and drinking caffeinated beverages during the study

Exclusion Criteria of Healthy volunteers:

  1. 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
  2. Have seizures, epilepsy, brain and nervous system symptoms or signs of history
  3. 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
  4. Has acute febrile diseases and infectious diseases
  5. Participate in other new drug clinical trials
  6. Participated in any other new drug clinical trials in 3 months
  7. Allergic people who have histories of allergy to two or more drugs/food allergy and physical scars, are allergic to alcohol or drugs known to the group of points
  8. Women who are in pregnancy or lactation
  9. People with mental or physical disabilities
  10. Researchers consider that any conditions may affect the trial evaluation

Inclusion Criteria of TB (tuberculosis)subjects:

  1. Diagnosis TB according to the health of the People's Republic of China industry standard WS 288-2008 tuberculosis diagnostic criteria
  2. Aged 18 to 65 years old
  3. Consent and signed ICF to participate in this study
  4. Comply with the requirements of the clinical research plan for follow-up

Exclusion Criteria of TB volunteers:

  1. Have 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
  2. Have seizures, epilepsy, brain and nervous system symptoms or signs of history;
  3. Have 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
  4. People in the pyrogenic stage with febrile diseases or infectious diseases (non tuberculosis)
  5. Participate in other new drug clinical trials
  6. Participated in any other new drug clinical trials in 3 months;
  7. Allergic people who have histories of allergy to two or more drugs/food allergy and physical scars, are allergic to alcohol or drugs known to the group of points;
  8. Women who are in pregnancy or lactation;
  9. People with mental or physical disabilities;
  10. Researchers consider that any conditions may affect the trial evaluation.
05

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
144 participants (actual)

Study arms

  • Experimental
    the healthy subjects

    The healthy subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative only one time , or 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative only one time , or 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative only one time , or 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative only one time .Right arm inject ESAT6-CFP10 and left arm inject tuberculin purified protein derivative. Two drugs must be use in the same subjects.

    Biological: 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative · Biological: 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative · Biological: 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative · Biological: 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative

  • Experimental
    the first part of tuberculosis subjects

    The first part kind of tuberculosis subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative only one time , or 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative only one time , or 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative only one time , or 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative only one time .Right arm inject ESAT6-CFP10 and left arm inject tuberculin purified protein derivative. Two drugs must be use in the same subjects.

    Biological: 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative · Biological: 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative · Biological: 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative · Biological: 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative

  • Experimental
    the second part of tuberculosis subjects

    The second part of tuberculosis subjects inject 1μg/ml ESAT6-CFP10 and placebo only one time , or 5μg/ml ESAT6-CFP10 and placebo only one time , or 10μg/ml ESAT6-CFP10 and placebo only one time , or 20μg/ml ESAT6-CFP10 and placebo only one time .Right arm inject ESAT6-CFP10 and left arm inject placebo. Two drugs must be use in the same subjects.

    Biological: 1μg/ml ESAT6-CFP10 and placebo · Biological: 5μg/ml ESAT6-CFP10 and placebo · Biological: 10μg/ml ESAT6-CFP10 and placebo · Biological: 20μg/ml ESAT6-CFP10 and placebo

Interventions

  • Biological1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative

    Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal injection 1μg/ml ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 Allergen and TB-PPD only one time in the healthy subjects and the first part of tuberculosis subjects respectively.

    Also known as: Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 /TB-PPD

  • Biological5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative

    Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal injection 5g/ml ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 Allergen and TB-PPD only one time in the healthy subjects and the first part of tuberculosis subjects respectively.

    Also known as: Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10/TB-PPD

  • Biological10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative

    Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal injection 10g/ml ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 Allergen and TB-PPD only one time in the healthy subjects and the first part of tuberculosis subjects respectively.

    Also known as: Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 /TB-PPD

  • Biological20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative

    Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal injection 20/ml ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 Allergen and TB-PPD only one time in the healthy subjects and the first part of tuberculosis subjects respectively.

    Also known as: Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 /TB-PPD

  • Biological1μg/ml ESAT6-CFP10 and placebo

    Left arm intradermal injection of the placebo of 1μg/ml ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal injection 1μg/ml ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in the second part of tuberculosis subjects.

    Also known as: Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10

  • Biological5μg/ml ESAT6-CFP10 and placebo

    Left arm intradermal injection of the placebo of 5μg/ml ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal injection 5μg/ml ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in the second part of tuberculosis subjects.

    Also known as: Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10

  • Biological10μg/ml ESAT6-CFP10 and placebo

    Left arm intradermal injection of the placebo of 10μg/ml ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal injection 10μg/ml ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in the second part of tuberculosis subjects.

    Also known as: Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10

  • Biological20μg/ml ESAT6-CFP10 and placebo

    Left arm intradermal injection of the placebo of 20μg/ml ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal injection 20μg/ml ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in the second part of tuberculosis subjects.

    Also known as: Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10

06

What researchers measure

Primary outcomes

  1. Number of Healthy Participants Negative for Reaction at 24 Hours After Intradermal Injection With ESAT6-CFP10

    The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in healthy participants at 24 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the healthy participants' arm are positive reaction. The percentage of negative(negative number/total number\*100%) is the specificity of ESAT6-CFP10 .

    Time frame: 24 hours after intradermal injection

  2. Number of Tuberculosis (TB) Participants Positive for Reaction at 24 Hours After Intradermal Injection With ESAT6-CFP10

    The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in TB participants at 24 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the participants' arm are positive reaction.

    Time frame: 24 hours after intradermal injection

  3. Number of Healthy Participants Negative for Reaction at 48 Hours After Intradermal Injection With ESAT6-CFP10

    The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in healthy participants at 48 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the healthy participants' arm are positive reaction.

    Time frame: 48 hours after intradermal injection

  4. Number of Tuberculosis (TB) Participants Positive for Reaction at 48 Hours After Intradermal Injection With ESAT6-CFP10

    The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in TB participants at 48 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the participants' arm are positive reaction.

    Time frame: 48 hours after intradermal injection

  5. Number of Healthy Participants Negative for Reaction at 72 Hours After Intradermal Injection With ESAT6-CFP10

    The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in healthy participants at 72 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the healthy participants' arm are positive reaction. The percentage of negative(negative number/total number\*100%) is the specificity of ESAT6-CFP10

    Time frame: 72 hours after intradermal injection

  6. Number of Tuberculosis (TB) Participants Positive for Reaction at 72 Hours After Intradermal Injection With ESAT6-CFP10

    The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in TB participants at 72 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the participants' arm are positive reaction.

    Time frame: 72 hours after intradermal injection

  7. Number of Healthy Participants Negative for Reaction at 96 Hours After Intradermal Injection With ESAT6-CFP10

    The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in healthy participants at 96 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the healthy participants' arm are positive reaction.

    Time frame: 96 hours after intradermal injection

  8. Number of Tuberculosis (TB) Participants Positive for Reaction at 96 Hours After Intradermal Injection With ESAT6-CFP10

    The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in TB participants at 96 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the participants' arm are positive reaction.

    Time frame: 96 hours after intradermal injection

Secondary outcomes

  1. the Number of Participants With Adverse Events

    evaluate specific time point of vital signs, skin test reaction, blood routine, urine routine, liver and kidney function, electrocardiogram and adverse events as the incidence of adverse events in the participants . Skin test reaction observation time: at the end of the skin test, skin test after 15 minutes, 1 hour, 4 hours, 24 hours, 48 hours, 72 hours, 96 hours; Vital signs evaluation time: 0 minutes before the subjects were intradermal injection, intradermal injection after 15 minutes, 1 hour, 4 hours, 24 hours, 48 hours, 72 hours, 96 hours, 144 hours. Blood routine, urine routine, liver and kidney function, electrocardiogram (ecg) evaluation time: skin test before and 144 h after injection; adverse events evaluation time: participants signed a written informed consent to finish all the follow-up.

    Time frame: before injection to 144 hours (plus or minus 2 hours) after injection

  2. the Number of Healthy Participants Negative for IFN-γ(Gamma Interferon ) Before Injection

    The investigator draw 5ml venous blood for detection of IFN-γ four hours before injection with drug.The percentage of negative(negative number/total number\*100%) is the specificity of IFN-γ in healthy participants.

    Time frame: before injection and after signed ICF(informed consent forms)

  3. the Number of Tuberculosis (TB) Participants Positive for IFN-γ(Gamma Interferon ) Before Injection

    The investigator draw 5ml venous blood for detection of IFN-γ four hours before injection with drug. The percentage of positive(positive number/total number\*100%) is the sensitivity of IFN-γ in TB Participants.

    Time frame: 4 hours before injection and after signed ICF(informed consent forms)

  4. the Number of Healthy Participants Negative for IFN-γ(Gamma Interferon ) at 72 Hours After Intradermal Injection With ESAT6-CFP10

    The investigator draw 5ml venous blood for detection of IFN-γ four hours before injection with drug.The percentage of negative(negative number/total number\*100%) is the specificity of IFN-γ in healthy participants.

    Time frame: 72 hours after injection

  5. the Number of Tuberculosis (TB) Participants Positive for IFN-γ(Gamma Interferon ) at 72 Hours After Intradermal Injection With ESAT6-CFP10

    The investigator draw 5ml venous blood for detection of IFN-γ 72 hours after injection with drug.The percentage of positive(positivenumber/total number\*100%) is the sensitivity of IFN-γ in in TB participants.

    Time frame: 72 hours after injection

  6. the Number of Healthy Participants Negative for IFN-γ(Gamma Interferon ) at 144 Hours After Intradermal Injection With ESAT6-CFP10

    The investigator draw 5ml venous blood for detection of IFN-γ 144 hours after injection with drug.The percentage of negative(negative number/total number\*100%) is the specificity of IFN-γ in healthy participants.

    Time frame: 144 hours after injection

  7. the Number of Tuberculosis (TB) Participants Positive for IFN-γ(Gamma Interferon ) at 144 Hours After Intradermal Injection With ESAT6-CFP10

    The investigator draw 5ml venous blood for detection of IFN-γ 144 hours before injection with drug.The percentage of positive(positive number/total number\*100%) is the sensitivity of IFN-γ in in TB participants.

    Time frame: 144 hours after injection

07

Results

Posted Apr 9, 2015

Participant flow

Participant flow — Overall Study
MilestoneHealthy Subjects-1μg/ml ESAT6-CFP10 & TB-PPDHealthy Subjects-5μg/ml ESAT6-CFP10 & TB-PPDHealthy Subjects-10μg/ml ESAT6-CFP10 & TB-PPDHealthy Subjects-20μg/ml ESAT6-CFP10 & TB-PPDTuberculosis Subjects-1μg/ml ESAT6-CFP10 & TB-PPDTuberculosis Subjects-5μg/ml ESAT6-CFP10 & TB-PPDTuberculosis Subjects-10μg/ml ESAT6-CFP10 & TB-PPDTuberculosis Subjects-20μg/ml ESAT6-CFP10 & TB-PPDTuberculosis Subjects-1μg/ml ESAT6-CFP10 & PlaceboTuberculosis Subjects-5μg/ml ESAT6-CFP10 & PlaceboTuberculosis Subjects-10μg/ml ESAT6-CFP10 & PlaceboTuberculosis Subjects-20μg/ml ESAT6-CFP10 & Placebo
Started14141414141414148888
Completed14141414111213137788
Not completed000032111100
Withdrew: Protocol violation000022000000
Withdrew: Withdrawal by subject000010111100

Outcome measures

PrimaryNumber of Healthy Participants Negative for Reaction at 24 Hours After Intradermal Injection With ESAT6-CFP10

The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in healthy participants at 24 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the healthy participants' arm are positive reaction. The percentage of negative(negative number/total number\*100%) is the specificity of ESAT6-CFP10 .

Time frame:
24 hours after intradermal injection
Reported as:
Number · participants
Number of Healthy Participants Negative for Reaction at 24 Hours After Intradermal Injection With ESAT6-CFP10
participants1μg/ml ESAT6-CFP105μg/ml ESAT6-CFP1010μg/ml ESAT6-CFP1020μg/ml ESAT6-CFP10
Number of Healthy Participants Negative for Reaction at 24 Hours After Intradermal Injection With ESAT6-CFP1013131413
Secondarythe Number of Participants With Adverse Events

evaluate specific time point of vital signs, skin test reaction, blood routine, urine routine, liver and kidney function, electrocardiogram and adverse events as the incidence of adverse events in the participants . Skin test reaction observation time: at the end of the skin test, skin test after 15 minutes, 1 hour, 4 hours, 24 hours, 48 hours, 72 hours, 96 hours; Vital signs evaluation time: 0 minutes before the subjects were intradermal injection, intradermal injection after 15 minutes, 1 hour, 4 hours, 24 hours, 48 hours, 72 hours, 96 hours, 144 hours. Blood routine, urine routine, liver and kidney function, electrocardiogram (ecg) evaluation time: skin test before and 144 h after injection; adverse events evaluation time: participants signed a written informed consent to finish all the follow-up.

Time frame:
before injection to 144 hours (plus or minus 2 hours) after injection
Reported as:
Number · participants
the Number of Participants With Adverse Events
participants1μg/ml ESAT6-CFP105μg/ml ESAT6-CFP1010μg/ml ESAT6-CFP1020μg/ml ESAT6-CFP10
the Number of Participants With Adverse Events16191914
Secondarythe Number of Healthy Participants Negative for IFN-γ(Gamma Interferon ) Before Injection

The investigator draw 5ml venous blood for detection of IFN-γ four hours before injection with drug.The percentage of negative(negative number/total number\*100%) is the specificity of IFN-γ in healthy participants.

Time frame:
before injection and after signed ICF(informed consent forms)
Reported as:
Number · participants
the Number of Healthy Participants Negative for IFN-γ(Gamma Interferon ) Before Injection
participants1μg/ml ESAT6-CFP105μg/ml ESAT6-CFP1010μg/ml ESAT6-CFP1020μg/ml ESAT6-CFP10
the Number of Healthy Participants Negative for IFN-γ(Gamma Interferon ) Before Injection12131313
Secondarythe Number of Tuberculosis (TB) Participants Positive for IFN-γ(Gamma Interferon ) Before Injection

The investigator draw 5ml venous blood for detection of IFN-γ four hours before injection with drug. The percentage of positive(positive number/total number\*100%) is the sensitivity of IFN-γ in TB Participants.

Time frame:
4 hours before injection and after signed ICF(informed consent forms)
Reported as:
Number · participants
the Number of Tuberculosis (TB) Participants Positive for IFN-γ(Gamma Interferon ) Before Injection
participants1μg/ml ESAT6-CFP105μg/ml ESAT6-CFP1010μg/ml ESAT6-CFP1020μg/ml ESAT6-CFP10
the Number of Tuberculosis (TB) Participants Positive for IFN-γ(Gamma Interferon ) Before Injection18171819
Secondarythe Number of Healthy Participants Negative for IFN-γ(Gamma Interferon ) at 72 Hours After Intradermal Injection With ESAT6-CFP10

The investigator draw 5ml venous blood for detection of IFN-γ four hours before injection with drug.The percentage of negative(negative number/total number\*100%) is the specificity of IFN-γ in healthy participants.

Time frame:
72 hours after injection
Reported as:
Number · participants
the Number of Healthy Participants Negative for IFN-γ(Gamma Interferon ) at 72 Hours After Intradermal Injection With ESAT6-CFP10
participants1μg/ml ESAT6-CFP105μg/ml ESAT6-CFP1010μg/ml ESAT6-CFP1020μg/ml ESAT6-CFP10
the Number of Healthy Participants Negative for IFN-γ(Gamma Interferon ) at 72 Hours After Intradermal Injection With ESAT6-CFP1013121313
Secondarythe Number of Tuberculosis (TB) Participants Positive for IFN-γ(Gamma Interferon ) at 72 Hours After Intradermal Injection With ESAT6-CFP10

The investigator draw 5ml venous blood for detection of IFN-γ 72 hours after injection with drug.The percentage of positive(positivenumber/total number\*100%) is the sensitivity of IFN-γ in in TB participants.

Time frame:
72 hours after injection
Reported as:
Number · participants
the Number of Tuberculosis (TB) Participants Positive for IFN-γ(Gamma Interferon ) at 72 Hours After Intradermal Injection With ESAT6-CFP10
participants1μg/ml ESAT6-CFP105μg/ml ESAT6-CFP1010μg/ml ESAT6-CFP1020μg/ml ESAT6-CFP10
the Number of Tuberculosis (TB) Participants Positive for IFN-γ(Gamma Interferon ) at 72 Hours After Intradermal Injection With ESAT6-CFP1018191819
Secondarythe Number of Healthy Participants Negative for IFN-γ(Gamma Interferon ) at 144 Hours After Intradermal Injection With ESAT6-CFP10

The investigator draw 5ml venous blood for detection of IFN-γ 144 hours after injection with drug.The percentage of negative(negative number/total number\*100%) is the specificity of IFN-γ in healthy participants.

Time frame:
144 hours after injection
Reported as:
Number · participants
the Number of Healthy Participants Negative for IFN-γ(Gamma Interferon ) at 144 Hours After Intradermal Injection With ESAT6-CFP10
participants1μg/ml ESAT6-CFP105μg/ml ESAT6-CFP1010μg/ml ESAT6-CFP1020μg/ml ESAT6-CFP10
the Number of Healthy Participants Negative for IFN-γ(Gamma Interferon ) at 144 Hours After Intradermal Injection With ESAT6-CFP1012111213
Secondarythe Number of Tuberculosis (TB) Participants Positive for IFN-γ(Gamma Interferon ) at 144 Hours After Intradermal Injection With ESAT6-CFP10

The investigator draw 5ml venous blood for detection of IFN-γ 144 hours before injection with drug.The percentage of positive(positive number/total number\*100%) is the sensitivity of IFN-γ in in TB participants.

Time frame:
144 hours after injection
Reported as:
Number · participants
the Number of Tuberculosis (TB) Participants Positive for IFN-γ(Gamma Interferon ) at 144 Hours After Intradermal Injection With ESAT6-CFP10
participants1μg/ml ESAT6-CFP105μg/ml ESAT6-CFP1010μg/ml ESAT6-CFP1020μg/ml ESAT6-CFP10
the Number of Tuberculosis (TB) Participants Positive for IFN-γ(Gamma Interferon ) at 144 Hours After Intradermal Injection With ESAT6-CFP1017191519
PrimaryNumber of Tuberculosis (TB) Participants Positive for Reaction at 24 Hours After Intradermal Injection With ESAT6-CFP10

The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in TB participants at 24 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the participants' arm are positive reaction.

Time frame:
24 hours after intradermal injection
Reported as:
Number · participants
Number of Tuberculosis (TB) Participants Positive for Reaction at 24 Hours After Intradermal Injection With ESAT6-CFP10
participants1μg/ml ESAT6-CFP105μg/ml ESAT6-CFP1010μg/ml ESAT6-CFP1020μg/ml ESAT6-CFP10
Number of Tuberculosis (TB) Participants Positive for Reaction at 24 Hours After Intradermal Injection With ESAT6-CFP1015191719
PrimaryNumber of Healthy Participants Negative for Reaction at 48 Hours After Intradermal Injection With ESAT6-CFP10

The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in healthy participants at 48 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the healthy participants' arm are positive reaction.

Time frame:
48 hours after intradermal injection
Reported as:
Number · participants
Number of Healthy Participants Negative for Reaction at 48 Hours After Intradermal Injection With ESAT6-CFP10
participants1μg/ml ESAT6-CFP105μg/ml ESAT6-CFP1010μg/ml ESAT6-CFP1020μg/ml ESAT6-CFP10
Number of Healthy Participants Negative for Reaction at 48 Hours After Intradermal Injection With ESAT6-CFP1013131313
PrimaryNumber of Tuberculosis (TB) Participants Positive for Reaction at 48 Hours After Intradermal Injection With ESAT6-CFP10

The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in TB participants at 48 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the participants' arm are positive reaction.

Time frame:
48 hours after intradermal injection
Reported as:
Number · participants
Number of Tuberculosis (TB) Participants Positive for Reaction at 48 Hours After Intradermal Injection With ESAT6-CFP10
participants1μg/ml ESAT6-CFP105μg/ml ESAT6-CFP1010μg/ml ESAT6-CFP1020μg/ml ESAT6-CFP10
Number of Tuberculosis (TB) Participants Positive for Reaction at 48 Hours After Intradermal Injection With ESAT6-CFP1015171716
PrimaryNumber of Healthy Participants Negative for Reaction at 72 Hours After Intradermal Injection With ESAT6-CFP10

The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in healthy participants at 72 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the healthy participants' arm are positive reaction. The percentage of negative(negative number/total number\*100%) is the specificity of ESAT6-CFP10

Time frame:
72 hours after intradermal injection
Reported as:
Number · participants
Number of Healthy Participants Negative for Reaction at 72 Hours After Intradermal Injection With ESAT6-CFP10
participants1μg/ml ESAT6-CFP105μg/ml ESAT6-CFP1010μg/ml ESAT6-CFP1020μg/ml ESAT6-CFP10
Number of Healthy Participants Negative for Reaction at 72 Hours After Intradermal Injection With ESAT6-CFP1013131313
PrimaryNumber of Tuberculosis (TB) Participants Positive for Reaction at 72 Hours After Intradermal Injection With ESAT6-CFP10

The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in TB participants at 72 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the participants' arm are positive reaction.

Time frame:
72 hours after intradermal injection
Reported as:
Number · participants
Number of Tuberculosis (TB) Participants Positive for Reaction at 72 Hours After Intradermal Injection With ESAT6-CFP10
participants1μg/ml ESAT6-CFP105μg/ml ESAT6-CFP1010μg/ml ESAT6-CFP1020μg/ml ESAT6-CFP10
Number of Tuberculosis (TB) Participants Positive for Reaction at 72 Hours After Intradermal Injection With ESAT6-CFP1015171716
PrimaryNumber of Healthy Participants Negative for Reaction at 96 Hours After Intradermal Injection With ESAT6-CFP10

The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in healthy participants at 96 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the healthy participants' arm are positive reaction.

Time frame:
96 hours after intradermal injection
Reported as:
Number · participants
Number of Healthy Participants Negative for Reaction at 96 Hours After Intradermal Injection With ESAT6-CFP10
participants1μg/ml ESAT6-CFP105μg/ml ESAT6-CFP1010μg/ml ESAT6-CFP1020μg/ml ESAT6-CFP10
Number of Healthy Participants Negative for Reaction at 96 Hours After Intradermal Injection With ESAT6-CFP1013131313
PrimaryNumber of Tuberculosis (TB) Participants Positive for Reaction at 96 Hours After Intradermal Injection With ESAT6-CFP10

The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in TB participants at 96 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the participants' arm are positive reaction.

Time frame:
96 hours after intradermal injection
Reported as:
Number · participants
Number of Tuberculosis (TB) Participants Positive for Reaction at 96 Hours After Intradermal Injection With ESAT6-CFP10
participants1μg/ml ESAT6-CFP105μg/ml ESAT6-CFP1010μg/ml ESAT6-CFP1020μg/ml ESAT6-CFP10
Number of Tuberculosis (TB) Participants Positive for Reaction at 96 Hours After Intradermal Injection With ESAT6-CFP1014171715

Adverse events

Collected over We collect all kinds of adverse events related to the study drugs from signed ICF to the seventh day after injection with skin drugs.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Healthy Subjects-1μg/ml ECand TB-PPD—0/14 (0%)3/14 (21.4%)
Healthy Subjects-5μg/ml EC and TB-PPD—0/14 (0%)6/14 (42.9%)
Healthy Subjects-10μg/ml EC and TB-PPD—0/14 (0%)1/14 (7.1%)
Healthy Subjects-20μg/ml EC and TB-PPD—0/14 (0%)1/14 (7.1%)
Tuberculosis Subjects- 1μg/mlEC and TB-PPD—0/14 (0%)4/14 (28.6%)
Tuberculosis Subjects- 5μg/ml EC and TB-PPD—0/14 (0%)4/14 (28.6%)
Tuberculosis Subjects- 10μg/ml EC and TB-PPD—0/14 (0%)2/14 (14.3%)
Tuberculosis Subjects- 20μg/ml EC and TB-PPD—0/14 (0%)3/14 (21.4%)
Tuberculosis Subjects- 1μg/ml EC and Placebo—0/8 (0%)0/8 (0%)
Tuberculosis Subjects- 5μg/ml EC and Placebo—0/8 (0%)3/8 (37.5%)
Tuberculosis Subjects- 10μg/ml EC and Placebo—0/8 (0%)4/8 (50%)
Tuberculosis Subjects- 20μg/ml EC and Placebo—0/8 (0%)3/8 (37.5%)
Most frequent other events
Most frequent other events
EventHealthy Subjects-1μg/ml ECand TB-PPDHealthy Subjects-5μg/ml EC and TB-PPDHealthy Subjects-10μg/ml EC and TB-PPDHealthy Subjects-20μg/ml EC and TB-PPDTuberculosis Subjects- 1μg/mlEC and TB-PPDTuberculosis Subjects- 5μg/ml EC and TB-PPDTuberculosis Subjects- 10μg/ml EC and TB-PPDTuberculosis Subjects- 20μg/ml EC and TB-PPDTuberculosis Subjects- 1μg/ml EC and PlaceboTuberculosis Subjects- 5μg/ml EC and PlaceboTuberculosis Subjects- 10μg/ml EC and PlaceboTuberculosis Subjects- 20μg/ml EC and Placebo
Itching at the injection siteSkin and subcutaneous tissue disorders3/143/141/141/143/143/141/143/140/82/83/83/8
Pain at the injection siteSkin and subcutaneous tissue disorders2/143/140/140/142/141/140/140/140/80/82/82/8
High blood pressureVascular disorders0/142/140/140/140/140/140/140/140/80/80/80/8
feverInvestigations0/140/140/140/140/140/140/140/140/80/80/81/8
vasculitisVascular disorders0/140/140/140/140/140/141/140/140/80/81/81/8
phlebitisVascular disorders0/140/140/140/140/141/140/140/140/81/80/80/8
Percentage abnormal of EosinophilsBlood and lymphatic system disorders0/140/140/140/140/140/140/140/140/80/80/81/8

Baseline characteristics

Each group of baseline analysis population apply full analysis set (FAS).FAS are the participant, following the principle of ITT, who receive at least once drug and have curative effect evaluation of drug treatment .Missing data of the curative effect part in FAS population use Last observation carried forward(LOCF)method to supplement.

Age, Continuous
Age, Continuous(years)1μg/ml ESAT6-CFP105μg/ml ESAT6-CFP1010μg/ml ESAT6-CFP1020μg/ml ESAT6-CFP10Total
Mean40.12 ± 12.8338.46 ± 11.9843.81 ± 12.5344.63 ± 12.3741.76 ± 12.42
Sex: Female, Male
Sex: Female, Male(Participants)1μg/ml ESAT6-CFP105μg/ml ESAT6-CFP1010μg/ml ESAT6-CFP1020μg/ml ESAT6-CFP10Total
Female1720161770
Male1814201971
height
height(cm)1μg/ml ESAT6-CFP105μg/ml ESAT6-CFP1010μg/ml ESAT6-CFP1020μg/ml ESAT6-CFP10Total
Mean166.83 ± 7.06166.32 ± 7.59167.44 ± 8.23165.47 ± 7.81166.52 ± 7.67
weight
weight(kg)1μg/ml ESAT6-CFP105μg/ml ESAT6-CFP1010μg/ml ESAT6-CFP1020μg/ml ESAT6-CFP10Total
Mean62.20 ± 9.7062.15 ± 9.8359.33 ± 9.4059.42 ± 11.5660.78 ± 10.12
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Study locations

No study locations are listed for this record.

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References and documents

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 10702486 ↗
  • Ravn P, Munk ME, Andersen AB, Lundgren B, Lundgren JD, Nielsen LN, Kok-Jensen A, Andersen P, Weldingh K. Prospective evaluation of a whole-blood test using Mycobacterium tuberculosis-specific antigens ESAT-6 and CFP-10 for diagnosis of active tuberculosis. Clin Diagn Lab Immunol. 2005 Apr;12(4):491-6. doi: 10.1128/CDLI.12.4.491-496.2005. PubMed 15817755 ↗
  • Brusasca PN, Colangeli R, Lyashchenko KP, Zhao X, Vogelstein M, Spencer JS, McMurray DN, Gennaro ML. Immunological characterization of antigens encoded by the RD1 region of the Mycobacterium tuberculosis genome. Scand J Immunol. 2001 Nov;54(5):448-52. doi: 10.1046/j.1365-3083.2001.00975.x. PubMed 11696195 ↗
  • Weldingh K, Andersen P. ESAT-6/CFP10 skin test predicts disease in M. tuberculosis-infected guinea pigs. PLoS One. 2008 Apr 23;3(4):e1978. doi: 10.1371/journal.pone.0001978. PubMed 18431468 ↗
  • Aagaard C, Govaerts M, Meikle V, Vallecillo AJ, Gutierrez-Pabello JA, Suarez-Guemes F, McNair J, Cataldi A, Espitia C, Andersen P, Pollock JM. Optimizing antigen cocktails for detection of Mycobacterium bovis in herds with different prevalences of bovine tuberculosis: ESAT6-CFP10 mixture shows optimal sensitivity and specificity. J Clin Microbiol. 2006 Dec;44(12):4326-35. doi: 10.1128/JCM.01184-06. Epub 2006 Sep 27. PubMed 17005738 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02329730
Lead sponsor
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Collaborators
Shanghai Public Health Clinical Center, Tianjin Haihe Hospital, Air Force Military Medical University, China, Proswell Medical Corporation
Responsible party
Sponsor
First posted
Jan 1, 2015
Start date
Feb 2014
Primary completion
Jun 2014
Completion
Aug 2014
Results posted
Apr 9, 2015
Last update
Apr 9, 2015

Study contacts

Shuihua Lu, Bachelor
principal investigator · Shanghai Public Health Clinical Center
Qi Wu, Master
principal investigator · Tianjin Haihe Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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