Phase III Clinical Study of Efficacy and Safety of Vaccae™ to Prevent Tuberculosis
Status:
Completed
Trial end date:
2017-11-26
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Collaborators:
Air Force Military Medical University, China Bei Jing SImoonrecord Pharma Information Consulting Co,.Ltd Fourth Military Medical University Guangxi Center for Disease Control and Prevention Jin Chengjiang Center for Disease Control and Prevention,China Liucheng County Disease Control and Prevention,China Liuzhou Center for Disease Control and Prevention,China National Institutes for Food and Drug Control, China National Institution for Food and Drug Control,China Rongshui County Disease Control and Prevention,China Simoon Record Pharma Information Consulting Co., Ltd.