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
NCT number | NCT01979900 |
Other study ID # | LTao |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | October 2013 |
Est. completion date | November 26, 2017 |
Verified date | August 2015 |
Source | Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10000 |
Est. completion date | November 26, 2017 |
Est. primary completion date | November 26, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 15 Years to 65 Years |
Eligibility |
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 exclusion criteria : - Suffering from any other serious disease, e.g. during cancer treatment, autoimmune disease, progressive atherosclerosis, diabetes accompanied with complications, chronic obstructive pulmonary disease (COPD) needing oxygen therapy, acute or progressive liver or kidney disease, congestive heart failure, etc. - Known allergy to experiment drugs - People with history of specific diagnosis of TB, extrapulmonary tuberculosis or have been cured - People have history of allergy, convulsions, epilepsy, cerebropathy, neurological symptoms and signs - Patients who have impaired or abnormal immune function, e.g. patients treated with immunosuppressor or immunopotentiator, received immunoglobulin preparation or blood products or plasma extraction outside the gastrointestinal tract in 3 months, human immunodeficiency virus or related diseases - Oral corticosteroids - Patients who have been using oral corticosteroids for more than 1 week, or hormone medication in vitro for a long time - Acute febrile illness and infection - Pregnant or lactating women, or women who have birth plan in following 2 years - Any other cases that may influence the test evaluation The second-sixth injection drug exclusion criteria : - Subjects whose compliance is poor, and can not take medicine on time or according to the amount - Patients who are using medicine and food that can influence the result - Pregnant subjects during the test - Patients who are reluctant to continue and require exit |
Country | Name | City | State |
---|---|---|---|
China | Jin Chengjiang Center for Diseases Control and Prevention, Hechi, Guangxi | Hechi | Guangxi |
China | Liucheng County Diseases Control and Prevention, Liuzhou, Guangxi | Liuzhou | Guangxi |
China | Liuzhou Center for Diseases Control and Prevention, Liuzhou, Guangxi | Liuzhou | Guangxi |
China | Rongshui County Diseases Control and Prevention, Liuzhou, Guangxi | Liuzhou | Guangxi |
Lead Sponsor | Collaborator |
---|---|
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. | 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, Rongshui County Disease Control and Prevention,China |
China,
Morán-Mendoza O, Marion SA, Elwood K, Patrick DM, FitzGerald JM. Tuberculin skin test size and risk of tuberculosis development: a large population-based study in contacts. Int J Tuberc Lung Dis. 2007 Sep;11(9):1014-20. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The whole TB incidence after injection of Vaccae | 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 | Terminal Stage: two years after the last group of subjects enrolled | |
Secondary | Lesion degree (Bacteriology indicators, cavity) of patients | 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 | two years after the last group of subjects enrolled or after observation of 76 cases of the disease | |
Secondary | Systemic and local reactions and adverse events | within 30 days after last dosing | within 30 days after last dosing | |
Secondary | The relation between skin test results and paroxysm of TB-PPD | 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 | Terminal Stage: two years after the last group of subjects enrolled or after observation of 76 cases of the disease |
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