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

NCT01979900 | Completed Phase 3 DMC

• 1 other identifier: LTao
• Study Type: interventional
• Target: 10,000
• Locations: 1 country
• Sites: 4

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.

Conditions

Tuberculosis

Keywords

TB Infection; Lesion Degree; Bacteriology Indicators; Cavity; Humoral Immunity; Cellular Immunologic Response

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Systemic and local reactions and adverse events

  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

Study Arms (2)

Vaccae

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Vaccae DRUG

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.

Also known as: Mycobacterium vaccae for Injection

Vaccae

placebo DRUG

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.

Also known as: Vaccae Lyophilized stabilizers

Placebo

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.: lead
• Guangxi Center for Disease Control and Prevention: collaborator
• Liuzhou Center for Disease Control and Prevention,China: collaborator
• Rongshui County Disease Control and Prevention,China: collaborator
• Liucheng County Disease Control and Prevention,China: collaborator
• Jin Chengjiang Center for Disease Control and Prevention,China: collaborator
• National Institutes for Food and Drug Control, China: collaborator
• Air Force Military Medical University, China: collaborator
• Simoon Record Pharma Information Consulting Co., Ltd.: collaborator

Study Sites (4)

Jin Chengjiang Center for Diseases Control and Prevention, Hechi, Guangxi

Hechi, Guangxi, 547000, China

Location

Liucheng County Diseases Control and Prevention, Liuzhou, Guangxi

Liuchow, Guangxi, 545000, China

Location

Liuzhou Center for Diseases Control and Prevention, Liuzhou, Guangxi

Liuchow, Guangxi, 545000, China

Location

Rongshui County Diseases Control and Prevention, Liuzhou, Guangxi

Liuchow, Guangxi, 545000, China

Location

Related Publications (1)

• Moran-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.

  PMID: 17705981 BACKGROUND

Related Links

• Center for drug evaluation, CFDA ,China

MeSH Terms

Conditions

Tuberculosis

Interventions

Injections

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 8, 2013
• Study Start: October 1, 2013
• Primary Completion: November 26, 2017
• Study Completion: November 26, 2017
• Last Updated: June 1, 2018

Record last verified: 2015-08

Locations

CN (4)