Tuberculosis Clinical Trial
Official title:
Phase III Clinical Study of Efficacy and Safety of Mycobacterium Vaccae to Prevent Tuberculosis in High Risk Groups of Tuberculosis Infection
Mycobacterium Vaccae for Injection (Trade Name "Vaccae") is a kind of bio-products developed
by Anhui Zhifei Longcom Biopharmaceutical Co.,Ltd.,and got "The New Drug Certificate "in
1999. Vaccae has been approved for adjuvant therapy of tuberculosis(TB), and is also the only
recommended drug in TB immunotherapy by WHO. It was approved for production and sale by Anhui
Zhifei Longcom Biopharmaceutical Co.,Ltd. in 2001, and got favourable comment in therapy of
tuberculosis.
The purpose of this study is to add new indications for Vaccae, mainly to prevent
Tuberculosis for high risk groups of Tuberculosis Infection . In December 2012, China Food
and Drug Administration approved of the plan "Phase III Clinical Study of Efficacy and Safety
of Mycobacterium Vaccae to Prevent Tuberculosis in high risk groups of Tuberculosis
Infection". In the test, 10,000 cases whose skin tests of PPD are strongly positive are
enrolled. Using random, double-blind, and placebo-controlled methods, the study is carried
out to evaluate the efficacy and safety of Vaccae in preventing Tuberculosis. Meanwhile, in
this test, TB incidence and degree of pathological changes of experimental group are lower
than that of control group, and no drug-related SAEs are reported in treatment groups.
The Main Purpose of the Study:
- Evaluation of efficacy of Vaccae to prevent Tuberculosis in high risk groups of
Tuberculosis Infection.
The Secondary Purpose of the Study:
- Evaluation of Lesion Degree ( Bacteriology Indicators, Cavity) of patients and its
relationship with Skin Test results of TB-PPD after Injection of Vaccae into the high
risk groups.
- Evaluation of Changes in Humoral Immunity and Cellular Immunologic Response Before and
After Injection of Vaccae
Test Hypothesis:
In the test, TB incidence and degree of pathological changes of experimental group are lower
than that of control group, and no drug-related SAEs are reported in treatment groups
Blinding and Random:
Using random, double-blind, and placebo-controlled methods, evaluation of the efficacy and
safety of Vaccae.
Using block randomization method, a random sequence was generated by the statistics personnel
in Fourth Military Medical University Clinical Evaluation Center using SAS9.1.3 statistical
software
The Unblinding includes the first time of Unblinding and the second time of Unblinding. The
first time of Unblinding only distinguish groups , and the second time of Unblinding will
uncover the final Blind Codes.
The Blind Codes of the design produce at one time, and unblinding will be carried out
respectively at the first year and the second year after the beginning of the experiment.
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