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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01979900
Recruitment Status : Completed
First Posted : November 8, 2013
Last Update Posted : June 1, 2018
Sponsor:
Collaborators:
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.
Information provided by (Responsible Party):
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

Study Description
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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.


Condition or disease Intervention/treatment Phase
Tuberculosis Drug: Vaccae Drug: placebo Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Phase III Clinical Study of Efficacy and Safety of Mycobacterium Vaccae to Prevent Tuberculosis in High Risk Groups of Tuberculosis Infection
Study Start Date : October 2013
Actual Primary Completion Date : November 26, 2017
Actual Study Completion Date : November 26, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Vaccae
Experiment group: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: 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.
Other Name: Mycobacterium vaccae for Injection
Placebo Comparator: Placebo
Placebo group: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
 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.
Other Name: Vaccae Lyophilized stabilizers


Outcome Measures
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Primary Outcome Measures :
  1. The whole TB incidence after injection of Vaccae [ Time Frame: 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 Outcome Measures :
  1. Lesion degree (Bacteriology indicators, cavity) of patients [ Time Frame: 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

  2. Systemic and local reactions and adverse events [ Time Frame: within 30 days after last dosing ]
    within 30 days after last dosing

  3. The relation between skin test results and paroxysm of TB-PPD [ Time Frame: 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01979900


Locations
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China, Guangxi
Jin Chengjiang Center for Diseases Control and Prevention, Hechi, Guangxi
Hechi, Guangxi, China, 547000
Liucheng County Diseases Control and Prevention, Liuzhou, Guangxi
Liuzhou, Guangxi, China, 545000
Liuzhou Center for Diseases Control and Prevention, Liuzhou, Guangxi
Liuzhou, Guangxi, China, 545000
Rongshui County Diseases Control and Prevention, Liuzhou, Guangxi
Liuzhou, Guangxi, China, 545000
Sponsors and Collaborators
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
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.
Investigators
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Principal Investigator: Guoai Si, Director Jin Chengjiang Center for Diseases Control and Prevention, Hechi, Guangxi
Principal Investigator: Mingqiang Li, Director Jin Chengjiang Center for Diseases Control and Prevention, Liuzhou, Guangxi
Principal Investigator: Keshua Meng, Director Rongshui County Diseases Control and Prevention, Liuzhou, Guangxi
Principal Investigator: Debiao Qiao, Director Liucheng County Diseases Control and Prevention, Liuzhou, Guangxi
More Information
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Additional Information:

Publications:

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Responsible Party: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
ClinicalTrials.gov Identifier: NCT01979900    
Other Study ID Numbers: LTao
First Posted: November 8, 2013    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: August 2015
Keywords provided by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.:
TB Infection
Lesion Degree
Bacteriology Indicators
 Cavity
Humoral Immunity
Cellular Immunologic Response
Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
 Bacterial Infections
Bacterial Infections and Mycoses
Infections