A multicenter, randomized, blind, controlled trial design was used to select 240 tuberculosis (TB) patients, 120 non-tuberculous community population with other lung diseases, and 420 healthy community population without other lung diseases who met the inclusion criteria of this study. Blood supply specific gamma-interferon (T-SPOT) detection was performed first. Then, EC and Purified Protein derivation of tuberculin (TB-PPD) skin tests were performed on both arms, and the recorded results were observed. The first 24 cases of TB patients, the first 12 cases of non-tuberculous community population with other lung diseases, and the first 42 cases of healthy community population without other lung diseases were included in the trial subgroup. Physical examination, blood routine, urine routine, liver and kidney function, and electrocardiogram tests were required before and 7 days after skin test after study number assignment.
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Measure the diameter of redness or induration at the reaction site
Timeframe: The skin test was performed at 0 minute after injection.
Measure the diameter of redness or induration at the reaction site
Timeframe: The skin test was performed at 24 hours after injection.
Measure the diameter of redness or induration at the reaction site
Timeframe: The skin test was performed at 48 hours after injection.
Measure the diameter of redness or induration at the reaction site
Timeframe: The skin test was performed at 72 hours after injection.
Evaluate the incidence of all adverse events
Timeframe: Incidence of all adverse events within 7 days after injection.
Evaluate the incidence of serious adverse event (SAE)
Timeframe: Incidence of SAE within 28 days after full vaccination
In subgroup, count the number of patients with changes in clinical significance of blood routine test before skin test compared with that 7 days after skin test
Timeframe: before injection
In subgroup, count the number of patients with changes in clinical significance of urine routine test before skin test compared with that 7 days after skin test
Timeframe: before injection
In subgroup, count the number of patients with changes in clinical significance of liver and kidney function test before skin test compared with that 7 days after skin test
Timeframe: before injection
In subgroup, count the number of patients with changes in clinical significance of electrocardiogram test before skin test compared with that 7 days after skin test
Timeframe: before injection
In subgroup, count the number of patients with changes in clinical significance of blood routine test 7 days after skin test compared with that before skin test
Timeframe: 7days after injection
In subgroup, count the number of patients with changes in clinical significance of urine routine test 7 days after skin test compared with that before skin test
Timeframe: 7days after injection
In subgroup, count the number of patients with changes in clinical significance of liver and kidney function test 7 days after skin test compared with that before skin test
Timeframe: 7days after injection
In subgroup, count the number of patients with changes in clinical significance of electrocardiogram test 7 days after skin test compared with that before skin test
Timeframe: 7days after injection