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

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.

Conditions

• Tuberculosis

Interventions

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.

Sponsors & Collaborators

• Guangxi Center for Disease Control and Prevention

  collaborator OTHER_GOV

• Liuzhou Center for Disease Control and Prevention,China

  collaborator UNKNOWN

• Rongshui County Disease Control and Prevention,China

  collaborator UNKNOWN

• Liucheng County Disease Control and Prevention,China

  collaborator UNKNOWN

• Jin Chengjiang Center for Disease Control and Prevention,China

  collaborator UNKNOWN

• National Institutes for Food and Drug Control, China

  collaborator OTHER

• Air Force Military Medical University, China

  collaborator OTHER

• Simoon Record Pharma Information Consulting Co., Ltd.

  collaborator INDUSTRY

• Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

  lead INDUSTRY

Principal Investigators

• Guoai Si, Director · Jin Chengjiang Center for Diseases Control and Prevention, Hechi, Guangxi

• Mingqiang Li, Director · Jin Chengjiang Center for Diseases Control and Prevention, Liuzhou, Guangxi

• Keshua Meng, Director · Rongshui County Diseases Control and Prevention, Liuzhou, Guangxi

• Debiao Qiao, Director · Liucheng County Diseases Control and Prevention, Liuzhou, Guangxi

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-10-31

Primary Completion

2017-11-26

Completion

2017-11-26

Countries

• China

Study Locations