NCT01979900

Phase III Clinical Study of Efficacy and Safety of Vaccae™ to Prevent Tuberculosis

Phase III Clinical Study of Efficacy and Safety of Mycobacterium Vaccae to Prevent Tuberculosis in High Risk Groups of Tuberculosis Infection

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 10,000 (actual)
• Sponsor: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. · Industry
• Sex: All
• Age: 15 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
DRUG	Vaccae	One vial of Vaccae diluted with 1.0ml sterile water for injection, take deep coxal muscle injection after shaking well, once every 2 weeks, 6 times totally.
DRUG	placebo	One vial of placebo diluted with 1.0ml sterile water for injection, take deep coxal muscle injection after shaking well，once every 2 weeks, 6 times totally.

Timeline

• Start date: 2013-10-01
• Primary completion: 2017-11-26
• Completion: 2017-11-26
• First posted: 2013-11-08
• Last updated: 2018-06-01

Locations

4 sites across 1 country: China