Tuberculosis Clinical Trial
Official title:
Phase IIa Clinical Study of Recombinant Mycobacterium Tuberculosis Antigen ESAT6-CFP10
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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