Trial Outcomes & Findings for Phase IIa Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 (NCT NCT02329730)

Results Overview

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 .

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

144 participants

Primary outcome timeframe

24 hours after intradermal injection

Results posted on

2015-04-09

Participant Flow

Participant milestones

Participant milestones
Measure	Healthy Subjects-1μg/ml ESAT6-CFP10 & TB-PPD The same healthy subjects inject 1μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects. 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 inject ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and TB-PPD only one time in every healthy subjects .	Healthy Subjects-5μg/ml ESAT6-CFP10 & TB-PPD The same healthy subjects inject 5μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects. 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 inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every healthy subjects .	Healthy Subjects-10μg/ml ESAT6-CFP10 & TB-PPD The same healthy subjects inject 10μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects. 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 inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every healthy subjects .	Healthy Subjects-20μg/ml ESAT6-CFP10 & TB-PPD The same healthy subjects inject 20μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects. 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 inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every healthy subjects .	Tuberculosis Subjects-1μg/ml ESAT6-CFP10 & TB-PPD The same tuberculosis subjects inject 1μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects. 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 inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every subjects .	Tuberculosis Subjects-5μg/ml ESAT6-CFP10 & TB-PPD The same tuberculosis subjects inject 5μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects. 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 inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every subjects .	Tuberculosis Subjects-10μg/ml ESAT6-CFP10 & TB-PPD The same tuberculosis subjects inject 10μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects. 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 inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every subjects .	Tuberculosis Subjects-20μg/ml ESAT6-CFP10 & TB-PPD The same tuberculosis subjects inject 20μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects. 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 inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every subjects .	Tuberculosis Subjects-1μg/ml ESAT6-CFP10 & Placebo The tuberculosis subjects inject 1μg/ml ESAT6-CFP10 and placebo of ESAT6-CFP10 only one time .Right arm inject ESAT6-CFP10 and left arm inject placebo. Two drugs must be use in the same subjects. Left arm intradermal injection of the placebo of ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in same tuberculosis subjects.	Tuberculosis Subjects-5μg/ml ESAT6-CFP10 & Placebo The tuberculosis subjects inject 5μg/ml ESAT6-CFP10 and placebo of ESAT6-CFP10 only one time .Right arm inject ESAT6-CFP10 and left arm inject placebo. Two drugs must be use in the same subjects. Left arm intradermal injection of the placebo of ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in same tuberculosis subjects.	Tuberculosis Subjects-10μg/ml ESAT6-CFP10 & Placebo The tuberculosis subjects inject 10μg/ml ESAT6-CFP10 and placebo of ESAT6-CFP10 only one time .Right arm inject ESAT6-CFP10 and left arm inject placebo. Two drugs must be use in the same subjects. Left arm intradermal injection of the placebo of ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in same tuberculosis subjects.	Tuberculosis Subjects-20μg/ml ESAT6-CFP10 & Placebo The tuberculosis subjects inject 20μg/ml ESAT6-CFP10 and placebo of ESAT6-CFP10 only one time .Right arm inject ESAT6-CFP10 and left arm inject placebo. Two drugs must be use in the same subjects. Left arm intradermal injection of the placebo of ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in same tuberculosis subjects.
Overall Study STARTED	14	14	14	14	14	14	14	14	8	8	8	8
Overall Study COMPLETED	14	14	14	14	11	12	13	13	7	7	8	8
Overall Study NOT COMPLETED	0	0	0	0	3	2	1	1	1	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Healthy Subjects-1μg/ml ESAT6-CFP10 & TB-PPD The same healthy subjects inject 1μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects. 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 inject ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and TB-PPD only one time in every healthy subjects .	Healthy Subjects-5μg/ml ESAT6-CFP10 & TB-PPD The same healthy subjects inject 5μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects. 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 inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every healthy subjects .	Healthy Subjects-10μg/ml ESAT6-CFP10 & TB-PPD The same healthy subjects inject 10μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects. 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 inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every healthy subjects .	Healthy Subjects-20μg/ml ESAT6-CFP10 & TB-PPD The same healthy subjects inject 20μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects. 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 inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every healthy subjects .	Tuberculosis Subjects-1μg/ml ESAT6-CFP10 & TB-PPD The same tuberculosis subjects inject 1μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects. 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 inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every subjects .	Tuberculosis Subjects-5μg/ml ESAT6-CFP10 & TB-PPD The same tuberculosis subjects inject 5μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects. 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 inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every subjects .	Tuberculosis Subjects-10μg/ml ESAT6-CFP10 & TB-PPD The same tuberculosis subjects inject 10μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects. 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 inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every subjects .	Tuberculosis Subjects-20μg/ml ESAT6-CFP10 & TB-PPD The same tuberculosis subjects inject 20μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects. 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 inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every subjects .	Tuberculosis Subjects-1μg/ml ESAT6-CFP10 & Placebo The tuberculosis subjects inject 1μg/ml ESAT6-CFP10 and placebo of ESAT6-CFP10 only one time .Right arm inject ESAT6-CFP10 and left arm inject placebo. Two drugs must be use in the same subjects. Left arm intradermal injection of the placebo of ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in same tuberculosis subjects.	Tuberculosis Subjects-5μg/ml ESAT6-CFP10 & Placebo The tuberculosis subjects inject 5μg/ml ESAT6-CFP10 and placebo of ESAT6-CFP10 only one time .Right arm inject ESAT6-CFP10 and left arm inject placebo. Two drugs must be use in the same subjects. Left arm intradermal injection of the placebo of ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in same tuberculosis subjects.	Tuberculosis Subjects-10μg/ml ESAT6-CFP10 & Placebo The tuberculosis subjects inject 10μg/ml ESAT6-CFP10 and placebo of ESAT6-CFP10 only one time .Right arm inject ESAT6-CFP10 and left arm inject placebo. Two drugs must be use in the same subjects. Left arm intradermal injection of the placebo of ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in same tuberculosis subjects.	Tuberculosis Subjects-20μg/ml ESAT6-CFP10 & Placebo The tuberculosis subjects inject 20μg/ml ESAT6-CFP10 and placebo of ESAT6-CFP10 only one time .Right arm inject ESAT6-CFP10 and left arm inject placebo. Two drugs must be use in the same subjects. Left arm intradermal injection of the placebo of ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in same tuberculosis subjects.
Overall Study Protocol Violation	0	0	0	0	2	2	0	0	0	0	0	0
Overall Study Withdrawal by Subject	0	0	0	0	1	0	1	1	1	1	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1μg/ml ESAT6-CFP10 n=35 Participants The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	5μg/ml ESAT6-CFP10 n=34 Participants The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	10μg/ml ESAT6-CFP10 n=36 Participants The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	20μg/ml ESAT6-CFP10 n=36 Participants The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	Total n=141 Participants Total of all reporting groups
Age, Continuous	40.12 years STANDARD_DEVIATION 12.83 • n=5 Participants	38.46 years STANDARD_DEVIATION 11.98 • n=7 Participants	43.81 years STANDARD_DEVIATION 12.53 • n=5 Participants	44.63 years STANDARD_DEVIATION 12.37 • n=4 Participants	41.76 years STANDARD_DEVIATION 12.42 • n=21 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	20 Participants n=7 Participants	16 Participants n=5 Participants	17 Participants n=4 Participants	70 Participants n=21 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	14 Participants n=7 Participants	20 Participants n=5 Participants	19 Participants n=4 Participants	71 Participants n=21 Participants
height	166.83 cm STANDARD_DEVIATION 7.06 • n=5 Participants	166.32 cm STANDARD_DEVIATION 7.59 • n=7 Participants	167.44 cm STANDARD_DEVIATION 8.23 • n=5 Participants	165.47 cm STANDARD_DEVIATION 7.81 • n=4 Participants	166.52 cm STANDARD_DEVIATION 7.67 • n=21 Participants
weight	62.20 kg STANDARD_DEVIATION 9.70 • n=5 Participants	62.15 kg STANDARD_DEVIATION 9.83 • n=7 Participants	59.33 kg STANDARD_DEVIATION 9.40 • n=5 Participants	59.42 kg STANDARD_DEVIATION 11.56 • n=4 Participants	60.78 kg STANDARD_DEVIATION 10.12 • n=21 Participants

PRIMARY outcome

Timeframe: 24 hours after intradermal injection

Population: The percentage of negative(negative number/total number\*100%) is the specificity of 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 .

Outcome measures

Outcome measures
Measure	1μg/ml ESAT6-CFP10 n=14 Participants The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	5μg/ml ESAT6-CFP10 n=14 Participants The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	10μg/ml ESAT6-CFP10 n=14 Participants The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	20μg/ml ESAT6-CFP10 n=14 Participants The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
Number of Healthy Participants Negative for Reaction at 24 Hours After Intradermal Injection With ESAT6-CFP10	13 participants	13 participants	14 participants	13 participants

PRIMARY outcome

Timeframe: 24 hours after intradermal injection

Population: The percentage of positive(positive number/total number\*100%) is the sensitivity of 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.

Outcome measures

Outcome measures
Measure	1μg/ml ESAT6-CFP10 n=18 Participants The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	5μg/ml ESAT6-CFP10 n=19 Participants The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	10μg/ml ESAT6-CFP10 n=21 Participants The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	20μg/ml ESAT6-CFP10 n=21 Participants The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
Number of Tuberculosis (TB) Participants Positive for Reaction at 24 Hours After Intradermal Injection With ESAT6-CFP10	15 participants	19 participants	17 participants	19 participants

PRIMARY outcome

Timeframe: 48 hours after intradermal injection

Population: The percentage of negative(negative number/total number\*100%) is the specificity of 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.

Outcome measures

Outcome measures
Measure	1μg/ml ESAT6-CFP10 n=14 Participants The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	5μg/ml ESAT6-CFP10 n=14 Participants The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	10μg/ml ESAT6-CFP10 n=14 Participants The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	20μg/ml ESAT6-CFP10 n=14 Participants The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
Number of Healthy Participants Negative for Reaction at 48 Hours After Intradermal Injection With ESAT6-CFP10	13 participants	13 participants	13 participants	13 participants

PRIMARY outcome

Timeframe: 48 hours after intradermal injection

Population: The percentage of positive(positive number/total number\*100%) is the sensitivity of 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.

Outcome measures

Outcome measures
Measure	1μg/ml ESAT6-CFP10 n=18 Participants The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	5μg/ml ESAT6-CFP10 n=19 Participants The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	10μg/ml ESAT6-CFP10 n=21 Participants The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	20μg/ml ESAT6-CFP10 n=21 Participants The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
Number of Tuberculosis (TB) Participants Positive for Reaction at 48 Hours After Intradermal Injection With ESAT6-CFP10	15 participants	17 participants	17 participants	16 participants

PRIMARY outcome

Timeframe: 72 hours after intradermal injection

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

Outcome measures

Outcome measures
Measure	1μg/ml ESAT6-CFP10 n=14 Participants The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	5μg/ml ESAT6-CFP10 n=14 Participants The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	10μg/ml ESAT6-CFP10 n=14 Participants The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	20μg/ml ESAT6-CFP10 n=14 Participants The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
Number of Healthy Participants Negative for Reaction at 72 Hours After Intradermal Injection With ESAT6-CFP10	13 participants	13 participants	13 participants	13 participants

PRIMARY outcome

Timeframe: 72 hours after intradermal injection

Population: The percentage of positive(positive number/total number\*100%) is the sensitivity of 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.

Outcome measures

Outcome measures
Measure	1μg/ml ESAT6-CFP10 n=18 Participants The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	5μg/ml ESAT6-CFP10 n=19 Participants The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	10μg/ml ESAT6-CFP10 n=21 Participants The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	20μg/ml ESAT6-CFP10 n=21 Participants The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
Number of Tuberculosis (TB) Participants Positive for Reaction at 72 Hours After Intradermal Injection With ESAT6-CFP10	15 participants	17 participants	17 participants	16 participants

PRIMARY outcome

Timeframe: 96 hours after intradermal injection

Population: The percentage of negative(negative number/total number\*100%) is the specificity of 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.

Outcome measures

Outcome measures
Measure	1μg/ml ESAT6-CFP10 n=14 Participants The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	5μg/ml ESAT6-CFP10 n=14 Participants The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	10μg/ml ESAT6-CFP10 n=14 Participants The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	20μg/ml ESAT6-CFP10 n=14 Participants The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
Number of Healthy Participants Negative for Reaction at 96 Hours After Intradermal Injection With ESAT6-CFP10	13 participants	13 participants	13 participants	13 participants

PRIMARY outcome

Timeframe: 96 hours after intradermal injection

Population: The percentage of positive(positive number/total number\*100%) is the sensitivity of 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.

Outcome measures

Outcome measures
Measure	1μg/ml ESAT6-CFP10 n=18 Participants The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	5μg/ml ESAT6-CFP10 n=19 Participants The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	10μg/ml ESAT6-CFP10 n=21 Participants The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	20μg/ml ESAT6-CFP10 n=21 Participants The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
Number of Tuberculosis (TB) Participants Positive for Reaction at 96 Hours After Intradermal Injection With ESAT6-CFP10	14 participants	17 participants	17 participants	15 participants

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	1μg/ml ESAT6-CFP10 n=36 Participants The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	5μg/ml ESAT6-CFP10 n=36 Participants The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	10μg/ml ESAT6-CFP10 n=36 Participants The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	20μg/ml ESAT6-CFP10 n=36 Participants The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
the Number of Participants With Adverse Events	16 participants	19 participants	19 participants	14 participants

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	1μg/ml ESAT6-CFP10 n=14 Participants The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	5μg/ml ESAT6-CFP10 n=14 Participants The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	10μg/ml ESAT6-CFP10 n=14 Participants The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	20μg/ml ESAT6-CFP10 n=14 Participants The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
the Number of Healthy Participants Negative for IFN-γ(Gamma Interferon ) Before Injection	12 participants	13 participants	13 participants	13 participants

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	1μg/ml ESAT6-CFP10 n=18 Participants The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	5μg/ml ESAT6-CFP10 n=19 Participants The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	10μg/ml ESAT6-CFP10 n=21 Participants The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	20μg/ml ESAT6-CFP10 n=21 Participants The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
the Number of Tuberculosis (TB) Participants Positive for IFN-γ(Gamma Interferon ) Before Injection	18 participants	17 participants	18 participants	19 participants

SECONDARY outcome

Timeframe: 72 hours after 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.

Outcome measures

Outcome measures
Measure	1μg/ml ESAT6-CFP10 n=14 Participants The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	5μg/ml ESAT6-CFP10 n=14 Participants The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	10μg/ml ESAT6-CFP10 n=14 Participants The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	20μg/ml ESAT6-CFP10 n=14 Participants The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
the Number of Healthy Participants Negative for IFN-γ(Gamma Interferon ) at 72 Hours After Intradermal Injection With ESAT6-CFP10	13 participants	12 participants	13 participants	13 participants

SECONDARY outcome

Timeframe: 72 hours after injection

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.

Outcome measures

Outcome measures
Measure	1μg/ml ESAT6-CFP10 n=18 Participants The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	5μg/ml ESAT6-CFP10 n=19 Participants The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	10μg/ml ESAT6-CFP10 n=21 Participants The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	20μg/ml ESAT6-CFP10 n=21 Participants The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
the Number of Tuberculosis (TB) Participants Positive for IFN-γ(Gamma Interferon ) at 72 Hours After Intradermal Injection With ESAT6-CFP10	18 participants	19 participants	18 participants	19 participants

SECONDARY outcome

Timeframe: 144 hours after injection

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.

Outcome measures

Outcome measures
Measure	1μg/ml ESAT6-CFP10 n=14 Participants The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	5μg/ml ESAT6-CFP10 n=14 Participants The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	10μg/ml ESAT6-CFP10 n=14 Participants The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).	20μg/ml ESAT6-CFP10 n=14 Participants The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
the Number of Healthy Participants Negative for IFN-γ(Gamma Interferon ) at 144 Hours After Intradermal Injection With ESAT6-CFP10	12 participants	11 participants	12 participants	13 participants

SECONDARY outcome

Timeframe: 144 hours after injection

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.