Tuberculosis
Conditions
Keywords
TB Infection, Lesion Degree, Bacteriology Indicators, Cavity, Humoral Immunity, Cellular Immunologic Response
Brief 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.
Interventions
DRUGVaccae
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.
DRUGplacebo
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.
Sponsors
Guangxi Center for Disease Control and Prevention
Liuzhou Center for Disease Control and Prevention,China
Rongshui County Disease Control and Prevention,China
Liucheng County Disease Control and Prevention,China
Jin Chengjiang Center for Disease Control and Prevention,China
National Institutes for Food and Drug Control, China
Air Force Military Medical University, China
Simoon Record Pharma Information Consulting Co., Ltd.
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
15 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged from 15 to 65 years old, all genders. * Skin test of Tuberculin Pure Protein Derivative (TB-PPD) is strongly positive ( the average diameter of PPD skin test induration is greater than or equal to 15mm,and（or）local blisters, necrosis). * Agreed to participate in the test and sign the informed consent. * Subjects agreed to participate in the experiments and voluntarily signed the informed consent. (guardians of 15-17- year-old subjects should agree, meanwhile). * The subjects should comply with the requirements of the clinical trial protocol and be Followed. * Have not participated in any other clinical trial for nearly three months. * Women of childbearing age from 15 to 49 years should agree with urine pregnancy tests and take effective birth control measures in two years after the medication. * Axillary temperature is normal.
Exclusion criteria
The first injection drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The whole TB incidence after injection of Vaccae | Terminal Stage: two years after the last group of subjects enrolled | Medium-term: one year after the last group of subjects enrolled or after observation of 38 cases of the disease, Terminal Stage: two years after the last group of subjects enrolled or after observation of 76 cases of the disease |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lesion degree (Bacteriology indicators, cavity) of patients | two years after the last group of subjects enrolled or after observation of 76 cases of the disease | Medium-term: one year after the last group of subjects enrolled or after observation of 38 cases of the disease, Terminal Stage: two years after the last group of subjects enrolled or after observation of 76 cases of the disease |
| Systemic and local reactions and adverse events | within 30 days after last dosing | within 30 days after last dosing |
| The relation between skin test results and paroxysm of TB-PPD | Terminal Stage: two years after the last group of subjects enrolled or after observation of 76 cases of the disease | Medium-term: one year after the last group of subjects enrolled or after observation of 38 cases of the disease, Terminal Stage: two years after the last group of subjects enrolled or after observation of 76 cases of the disease |
Countries
China
Outcome results
None listed