TuberculosisPhase 3NCT01979900
Phase III Clinical Study of Efficacy and Safety of Vaccae™ to Prevent Tuberculosis
A Phase 3 study testing Vaccae in people with Tuberculosis, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Vaccae
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10,000 participants
- Where
- 4 sitesChina
- Study dates
- Oct 2013to 26 Nov 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 1 country.
China4 sites
Jin Chengjiang Center for Diseases Control and Prevention, Hechi, Guangxi
Hechi, Guangxi, 547000
Liucheng County Diseases Control and Prevention, Liuzhou, Guangxi
Liuzhou, Guangxi, 545000
Liuzhou Center for Diseases Control and Prevention, Liuzhou, Guangxi
Liuzhou, Guangxi, 545000
Rongshui County Diseases Control and Prevention, Liuzhou, Guangxi
Liuzhou, Guangxi, 545000
About this study
Official title: Phase III Clinical Study of Efficacy and Safety of Mycobacterium Vaccae to Prevent Tuberculosis in High Risk Groups of Tuberculosis Infection
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.
Read the 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.
- Conditions
- Tuberculosis
- Being tested
- Vaccae, placebo
- Keywords
- TB Infection, Lesion Degree, Bacteriology Indicators, Cavity, Humoral Immunity, Cellular Immunologic Response
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VaccaeDrug
Also called Mycobacterium vaccae for Injection
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.
placeboDrug
Also called Vaccae Lyophilized stabilizers
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Terminal Stage: two years after the last group of subjects enrolled
Secondary outcomes (3)
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
Measured: 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
Measured: within 30 days after last dosing
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
Measured: Terminal Stage: two years after the last group of subjects enrolled or after observation of 76 cases of the disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startOct 2013
- Primary completion26 Nov 2017
- Study completion26 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- 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.
- Responsible party
- Sponsor
- Investigators
- Guoai Si, Director, Principal investigator, Jin Chengjiang Center for Diseases Control and Prevention, Hechi, GuangxiMingqiang Li, Director, Principal investigator, Jin Chengjiang Center for Diseases Control and Prevention, Liuzhou, GuangxiKeshua Meng, Director, Principal investigator, Rongshui County Diseases Control and Prevention, Liuzhou, GuangxiDebiao Qiao, Director, Principal investigator, Liucheng County Diseases Control and Prevention, Liuzhou, Guangxi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979900
- Sponsor's protocol ID
- LTao
- Status last verified
- Aug 2015
- First submitted
- 4 Nov 2013
- Last updated
- 1 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17705981
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Clinical Study of Efficacy and Safety of Mycobacterium Vaccae to Prevent Tuberculosis in High Risk Groups of Tuberculosis Infection
- ClinicalTrials.gov ID
- NCT01979900
- Acronym / sponsor ID
- LTao
- Conditions
- Tuberculosis
- Keywords
- TB Infection, Lesion Degree, Bacteriology Indicators, Cavity, Humoral Immunity, Cellular Immunologic Response
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Industry (pharma, biotech, devices)
- 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.
- Study start
- Oct 2013
- Primary completion
- 26 Nov 2017 (actual)
- Study completion
- 26 Nov 2017 (actual)
- First posted
- 8 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccae | Experimental | Drug: VaccaeExperiment 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. |
| Placebo | Placebo comparator | Drug: placeboPlacebo 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 |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VaccaeAlso: Mycobacterium vaccae for InjectionOne 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 |
| placeboAlso: Vaccae Lyophilized stabilizersOne 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 |
Primary outcome
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
3 secondary outcomes
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
Systemic and local reactions and adverse events
Time frame: within 30 days after last dosing
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2018.
- Background: PubMed 17705981Moran-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.
- Center for drug evaluation, CFDA ,ChinaLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guoai Si, Director principal investigator
Jin Chengjiang Center for Diseases Control and Prevention, Hechi, Guangxi
Mingqiang Li, Director principal investigator
Jin Chengjiang Center for Diseases Control and Prevention, Liuzhou, Guangxi
Keshua Meng, Director principal investigator
Rongshui County Diseases Control and Prevention, Liuzhou, Guangxi
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vaccae in people with Tuberculosis, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The whole TB incidence after injection of Vaccae (time frame: Terminal Stage: two years after the last group of subjects enrolled). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01979900, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2018.