Phase III Clinical Study of Efficacy and Safety of Vaccae™ to Prevent Tuberculosis
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Vaccae; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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.
Other intervention name(s): Mycobacterium vaccae for Injection; Vaccae Lyophilized stabilizers
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: TB Infection; Lesion Degree; Bacteriology Indicators; Cavity; Humoral Immunity; Cellular Immunologic Response