TuberculosisPhase 2NCT05284812
A Phase Ⅱ Clinical Trial of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried (AEC/BC02)
A Phase 2 study testing Low-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02), High-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02) and High-dose adjuvant for freeze-dried recombinant tuberculosis vaccine (AEC / BC02) in people with Tuberculosis, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 1 site in China.
Trial summary
The safety, tolerability and immunogenicity of lyophilized recombinant tuberculosis vaccine (AEC/BC02) were studied in a randomized, blind, controlled phase ⅱ A clinical study in patients 18 years and older with latent infection of Mycobacterium tuberculosis.Twenty patients with negative control group and 180 patients… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Low-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02), High-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02) and High-dose adjuvant for freeze-dried recombinant tuberculosis vaccine (AEC / BC02)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2022to 31 Dec 2024
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The age is 18 years old and above, and the gender is not limited;
- I agree to participate in this study and sign the informed consent;
- I can complete the whole process of clinical research in accordance with the requirements of the clinical research program;
- Vital signs (reference range of normal values of vital signs: systolic blood pressure <160 mmHg and diastolic blood pressure <100 mmHg (which can be controlled by taking medicine), pulse 60-100 beats/min, axillary temperature <37.3 ℃ in a quiet state), Physical examination results show no abnormality or abnormality without clinical significance;
- Negative control population: the test results are EC- and PPD- (the average diameter of EC skin test induration and flush is less than 5mm, and the PPD skin test induration is less than 5mm), and the chest imaging is normal;
- People with latent infection of Mycobacterium tuberculosis: the test result is EC+ (EC skin test induration or flush ≥5mm), and the chest imaging is normal;
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- Laboratory tests including blood routine, urine routine, blood biochemistry and other tests are all normal or have no clinical significance;
- There is no abnormality in the electrocardiogram examination or the abnormality has no clinical significance;
- Those who have no history of tuberculosis after medical history inquiry.
Who cannot join
- Those who are currently diagnosed with tuberculosis or have a history of tuberculosis and/or tuberculosis treatment;
- There are serious chronic diseases or the disease is in the advanced stage and cannot be controlled smoothly, such as diabetes and thyroid disease;
- Currently suffering from or within 2 years of any of the following serious diseases, such as: advanced tumor, autoimmune disease, progressive atherosclerosis, acute exacerbation of chronic obstructive pulmonary disease, acute or progressive liver or kidney disease, congestive heart failure exhaustion, etc.;
- Those with known or suspected (or high-risk) immune function impairments or abnormalities, such as those receiving systemic glucocorticoids, immunosuppressants or immunosuppressants within 3 months, and within 3 months Those who received protein preparations or blood products or plasma extracts outside the gastrointestinal tract;
- Existing mental/neurological diseases or history of mental/neurological diseases: those with convulsions, epilepsy, encephalopathy, or family history of mental illness;
- Those who currently suffer from biliary obstruction;
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- People with allergic constitution, such as those with a history of allergy to two or more drugs or foods; a history of severe allergy to any component of the test vaccine, such as: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenia Purpura, dyspnea, angioedema, etc.; or a history of the above-mentioned serious side effects after using any vaccine or drug in the past; a history of allergy to isoniazid tablets, rifampicin and rifamycin antibiotics;
- Patients with severe liver insufficiency, or patients with drug-induced hepatitis and acute liver disease caused by any cause;
- Difficulty swallowing, active or clinically significant digestive system diseases, and affecting drug absorption;
- Current patients with active viral hepatitis and/or HIV antibody positive for human immunodeficiency virus and/or current or past syphilis;
- Women who are pregnant, breastfeeding, or have a positive urine pregnancy test during the screening period, or before vaccination, or who have childbearing plans during the study period;
- Those who are vaccinated with inactivated vaccine within 14 days before oral administration of chemical drugs, and those who are vaccinated with live attenuated vaccine within 30 days;
- Those who have participated in any other clinical research and used the investigational drug within 3 months before this clinical research;
- Any other situation that the researcher believes may affect the evaluation of the research.
Trial locations and contacts
1 site in 1 country.
China1 site
Hunan Provincial Center for Disease Control and Prevention
Changsha, Hunan, 410005
About this study
Official title: A Phase Ⅱ Study on the Safety, Tolerability and Immunogenicity of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried
The safety, tolerability and immunogenicity of lyophilized recombinant tuberculosis vaccine (AEC/BC02) were studied in a randomized, blind, controlled phase ⅱ A clinical study in patients 18 years and older with latent infection of Mycobacterium tuberculosis.Twenty patients with negative control group and 180 patients with latent mycobacterium tuberculosis infection were divided into sentinel group, placebo group, high-dose adjuvant group, low-dose vaccine group, high-dose vaccine group and high-dose vaccine group (three doses).During the test, each subject shall not change groups or receive drugs.The negative control group did not take chemical drugs and did not get vaccinated after enrollment, and was only used as immunogenicity control.The latent infection group was given orally Koch inhibitor chemical drugs (Ifu tablet or Ifu capsule) or placebo twice a week, and then received placebo, adjuvant or vaccine every two weeks (0-2-4-6-8-10 weeks), with a total of 6 doses injected intramuscular alternately in the left and right arms of the upper arm deltoid muscle.
- Conditions
- Tuberculosis
- Being tested
- Low-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02), High-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02), High-dose adjuvant for freeze-dried recombinant tuberculosis vaccine (AEC / BC02), Lyophilized recombinant tuberculosis vaccine (AEC / BC02) placebo
- Keywords
- Tuberculosis, Vaccine
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02)Biological
Subjects receive low-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02) injection into the deltoid muscle of the upper arm
High-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02)Biological
Subjects receive high-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02) injection into the deltoid muscle of the upper arm
High-dose adjuvant for freeze-dried recombinant tuberculosis vaccine (AEC / BC02)Biological
Subjects receive high-dose adjuvant for freeze-dried recombinant tuberculosis vaccine (AEC / BC02) injection into the deltoid muscle of the upper arm
Lyophilized recombinant tuberculosis vaccine (AEC / BC02) placeboBiological
Subjects receive Lyophilized recombinant tuberculosis vaccine (AEC / BC02) placebo injection into the deltoid muscle of the upper arm
| Study group | Role | What they receive |
|---|---|---|
| Negative control population group | No intervention | In population I, 20 subjects were considered to be recombinant mycobacterium tuberculosis fusion protein (EC) and BCG pure protein derivative (BCG-PPD) skin test results were negative.The type I population did not take chemical drugs and was not vaccinated, and was only used as immunogenicity control. |
| Sentinel group | Other | In Population Ⅱ, 20 subjects were considered to be recombinant mycobacterium tuberculosis fusion protein (EC) was positive. First, 5 people aged 18-59 years were selected for low dose injection, 5 people aged 18-59 years were selected for high dose injection, 5 people aged ≥60 years were selected for low dose injection, and 5 people aged ≥60 years were selected for high dose injection.The subjects received a total of 6 doses of the vaccine, 1 dose every 2 weeks. Receives: Biological: Low-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02); Biological: High-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02) |
| Low-dose group | Experimental | In population Ⅲ, 40 subjects were considered to be recombinant mycobacterium tuberculosis fusion protein (EC) was positive. The type Ⅲ population were injected Low-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02).The subjects received a total of 6 doses of the vaccine, 1 dose every 2 weeks. Receives: Biological: Low-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02) |
| High-dose group | Experimental | In population Ⅳ, 40 subjects were considered to be recombinant mycobacterium tuberculosis fusion protein (EC) was positive. The type Ⅳ population were injected High-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02).The subjects received a total of 6 doses of the vaccine, 1 dose every 2 weeks. Receives: Biological: High-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02) |
| 3 dose of High-dose group | Experimental | In population Ⅴ, 40 subjects were considered to be recombinant mycobacterium tuberculosis fusion protein (EC) was positive. The type Ⅴ population were injected 3 dose of High-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02) and 3 dose of Lyophilized recombinant tuberculosis vaccine (AEC / BC02) placebo.The first, third, and sixth doses of the subjects were High-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02), and the second, fourth, and fifth doses were Lyophilized recombinant tuberculosis vaccine (AEC / BC02) placebo. Each dose is 2 weeks apart. Receives: Biological: High-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02); Biological: Lyophilized recombinant tuberculosis vaccine (AEC / BC02) placebo |
| Placebo group | Placebo comparator | In population Ⅵ, 20 subjects were considered to be recombinant mycobacterium tuberculosis fusion protein (EC) was positive. The type Ⅵ population were injected Lyophilized recombinant tuberculosis vaccine (AEC / BC02) placebo.The subjects received a total of 6 doses of the vaccine, 1 dose every 2 weeks. Receives: Biological: Lyophilized recombinant tuberculosis vaccine (AEC / BC02) placebo |
| Adjuvant group | Active comparator | In population Ⅶ, 20 subjects were considered to be recombinant mycobacterium tuberculosis fusion protein (EC) was positive. The type Ⅶ population were injected High-dose adjuvant for freeze-dried recombinant tuberculosis vaccine (AEC / BC02).The subjects received a total of 6 doses of the vaccine, 1 dose every 2 weeks. Receives: Biological: High-dose adjuvant for freeze-dried recombinant tuberculosis vaccine (AEC / BC02) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of adverse events after intramuscular injection
The observation of adverse events mainly come from vital sign detection and laboratory examination (including blood routine/urine routine/blood biochemistry/electrocardiogram and chest X-ray), local reactions and systemic reactions after injection.
Measured: Up to 6 months after the sixth time injection
Secondary outcomes (3)
Laboratory markers of immunity
Changes in the levels of antigen-specific total IgG antibodies and IgG subclasses (IgG1 and IgG2).
Measured: Up to 3 months after the sixth time injection
Laboratory markers of immunity
Changes in the levels of antigen-specific IFN-γ levels.
Measured: Up to 3 months after the sixth time injection
Laboratory markers of immunity
The changes of the proportion of antigen-specific T cells in PBMCs.
Measured: Up to 3 months after the sixth time injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start10 Feb 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Why it stopped: It is planned to restart the clinical study after the completion of the clinical trial protocol modification.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tao Huang, Bachelor, Principal investigator, Hunan Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284812
- Sponsor's protocol ID
- LKM-2021-BJH01
- Status last verified
- Nov 2023
- First submitted
- 21 Feb 2022
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pulendran B, Ahmed R. Immunological mechanisms of vaccination. Nat Immunol. 2011 Jun;12(6):509-17. doi: 10.1038/ni.2039.
PubMed 21739679Chen L, Xu M, Wang ZY, Chen BW, Du WX, Su C, Shen XB, Zhao AH, Dong N, Wang YJ, Wang GZ. The development and preliminary evaluation of a new Mycobacterium tuberculosis vaccine comprising Ag85b, HspX and CFP-10:ESAT-6 fusion protein with CpG DNA and aluminum hydroxide adjuvants. FEMS Immunol Med Microbiol. 2010 Jun 1;59(1):42-52. doi: 10.1111/j.1574-695X.2010.00660.x. Epub 2010 Feb 17.
PubMed 20298499Li J, Fu L, Guo X, Yang Y, Dong J, Wang G, Zhao A. Novel BC02 Compound Adjuvant Enhances Adaptive and Innate Immunity Induced by Recombinant Glycoprotein E of Varicella-Zoster Virus. Vaccines (Basel). 2022 Dec 15;10(12):2155. doi: 10.3390/vaccines10122155.
PubMed 36560565
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅱ Study on the Safety, Tolerability and Immunogenicity of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried
- ClinicalTrials.gov ID
- NCT05284812
- Acronym / sponsor ID
- LKM-2021-BJH01
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis, Vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: It is planned to restart the clinical study after the completion of the clinical trial protocol modification.
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 17 Mar 2022 (actual)
- 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.
The safety, tolerability and immunogenicity of lyophilized recombinant tuberculosis vaccine (AEC/BC02) were studied in a randomized, blind, controlled phase ⅱ A clinical study in patients 18 years and older with latent infection of Mycobacterium tuberculosis.Twenty patients with negative control group and 180 patients with latent mycobacterium tuberculosis infection were divided into sentinel group, placebo group, high-dose adjuvant group, low-dose vaccine group, high-dose vaccine group and high-dose vaccine group (three doses).During the test, each subject shall not change groups or receive drugs.The negative control group did not take chemical drugs and did not get vaccinated after enrollment, and was only used as immunogenicity control.The latent infection group was given orally Koch inhibitor chemical drugs (Ifu tablet or Ifu capsule) or placebo twice a week, and then received placebo, adjuvant or vaccine every two weeks (0-2-4-6-8-10 weeks), with a total of 6 doses injected intramuscular alternately in the left and right arms of the upper arm deltoid muscle.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Negative control population group | No intervention | –In population I, 20 subjects were considered to be recombinant mycobacterium tuberculosis fusion protein (EC) and BCG pure protein derivative (BCG-PPD) skin test results were negative.The type I population did not take chemical drugs and was not vaccinated, and was only used as immunogenicity control. |
| Sentinel group | Other | Biological: Low-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02), Biological: High-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02)In Population Ⅱ, 20 subjects were considered to be recombinant mycobacterium tuberculosis fusion protein (EC) was positive. First, 5 people aged 18-59 years were selected for low dose injection, 5 people aged 18-59 years were selected for high dose injection, 5 people aged ≥60 years were selected for low dose injection, and 5 people aged ≥60 years were selected for high dose injection.The subjects received a total of 6 doses of the vaccine, 1 dose every 2 weeks. |
| Low-dose group | Experimental | Biological: Low-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02)In population Ⅲ, 40 subjects were considered to be recombinant mycobacterium tuberculosis fusion protein (EC) was positive. The type Ⅲ population were injected Low-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02).The subjects received a total of 6 doses of the vaccine, 1 dose every 2 weeks. |
| High-dose group | Experimental | Biological: High-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02)In population Ⅳ, 40 subjects were considered to be recombinant mycobacterium tuberculosis fusion protein (EC) was positive. The type Ⅳ population were injected High-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02).The subjects received a total of 6 doses of the vaccine, 1 dose every 2 weeks. |
| 3 dose of High-dose group | Experimental | Biological: High-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02), Biological: Lyophilized recombinant tuberculosis vaccine (AEC / BC02) placeboIn population Ⅴ, 40 subjects were considered to be recombinant mycobacterium tuberculosis fusion protein (EC) was positive. The type Ⅴ population were injected 3 dose of High-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02) and 3 dose of Lyophilized recombinant tuberculosis vaccine (AEC / BC02) placebo.The first, third, and sixth doses of the subjects were High-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02), and the second, fourth, and fifth doses were Lyophilized recombinant tuberculosis vaccine (AEC / BC02) placebo. Each dose is 2 weeks apart. |
| Placebo group | Placebo comparator | Biological: Lyophilized recombinant tuberculosis vaccine (AEC / BC02) placeboIn population Ⅵ, 20 subjects were considered to be recombinant mycobacterium tuberculosis fusion protein (EC) was positive. The type Ⅵ population were injected Lyophilized recombinant tuberculosis vaccine (AEC / BC02) placebo.The subjects received a total of 6 doses of the vaccine, 1 dose every 2 weeks. |
| Adjuvant group | Active comparator | Biological: High-dose adjuvant for freeze-dried recombinant tuberculosis vaccine (AEC / BC02)In population Ⅶ, 20 subjects were considered to be recombinant mycobacterium tuberculosis fusion protein (EC) was positive. The type Ⅶ population were injected High-dose adjuvant for freeze-dried recombinant tuberculosis vaccine (AEC / BC02).The subjects received a total of 6 doses of the vaccine, 1 dose every 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The age is 18 years old and above, and the gender is not limited;
- I agree to participate in this study and sign the informed consent;
- I can complete the whole process of clinical research in accordance with the requirements of the clinical research program;
- Vital signs (reference range of normal values of vital signs: systolic blood pressure <160 mmHg and diastolic blood pressure <100 mmHg (which can be controlled by taking medicine), pulse 60-100 beats/min, axillary temperature <37.3 ℃ in a quiet state), Physical examination results show no abnormality or abnormality without clinical significance;
- Negative control population: the test results are EC- and PPD- (the average diameter of EC skin test induration and flush is less than 5mm, and the PPD skin test induration is less than 5mm), and the chest imaging is normal;
Key exclusion criteria (14 listed)
- Those who are currently diagnosed with tuberculosis or have a history of tuberculosis and/or tuberculosis treatment;
- There are serious chronic diseases or the disease is in the advanced stage and cannot be controlled smoothly, such as diabetes and thyroid disease;
- Currently suffering from or within 2 years of any of the following serious diseases, such as: advanced tumor, autoimmune disease, progressive atherosclerosis, acute exacerbation of chronic obstructive pulmonary disease, acute or progressive liver or kidney disease, congestive heart failure exhaustion, etc.;
- Those with known or suspected (or high-risk) immune function impairments or abnormalities, such as those receiving systemic glucocorticoids, immunosuppressants or immunosuppressants within 3 months, and within 3 months Those who received protein preparations or blood products or plasma extracts outside the gastrointestinal tract;
- Existing mental/neurological diseases or history of mental/neurological diseases: those with convulsions, epilepsy, encephalopathy, or family history of mental illness;
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 |
|---|---|---|
| Low-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02)Subjects receive low-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02) injection into the deltoid muscle of the upper arm | Biological | Low-dose group, Sentinel group |
| High-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02)Subjects receive high-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02) injection into the deltoid muscle of the upper arm | Biological | 3 dose of High-dose group, High-dose group, Sentinel group |
| High-dose adjuvant for freeze-dried recombinant tuberculosis vaccine (AEC / BC02)Subjects receive high-dose adjuvant for freeze-dried recombinant tuberculosis vaccine (AEC / BC02) injection into the deltoid muscle of the upper arm | Biological | Adjuvant group |
| Lyophilized recombinant tuberculosis vaccine (AEC / BC02) placeboSubjects receive Lyophilized recombinant tuberculosis vaccine (AEC / BC02) placebo injection into the deltoid muscle of the upper arm | Biological | 3 dose of High-dose group, Placebo group |
Primary outcome
The number of adverse events after intramuscular injection
Time frame: Up to 6 months after the sixth time injection
The observation of adverse events mainly come from vital sign detection and laboratory examination (including blood routine/urine routine/blood biochemistry/electrocardiogram and chest X-ray), local reactions and systemic reactions after injection.
3 secondary outcomes
Laboratory markers of immunity
Time frame: Up to 3 months after the sixth time injection
Laboratory markers of immunity
Time frame: Up to 3 months after the sixth time injection
Laboratory markers of immunity
Time frame: Up to 3 months after the sixth time injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Background: PubMed 21739679Pulendran B, Ahmed R. Immunological mechanisms of vaccination. Nat Immunol. 2011 Jun;12(6):509-17. doi: 10.1038/ni.2039.
- Background: PubMed 20298499Chen L, Xu M, Wang ZY, Chen BW, Du WX, Su C, Shen XB, Zhao AH, Dong N, Wang YJ, Wang GZ. The development and preliminary evaluation of a new Mycobacterium tuberculosis vaccine comprising Ag85b, HspX and CFP-10:ESAT-6 fusion protein with CpG DNA and aluminum hydroxide adjuvants. FEMS Immunol Med Microbiol. 2010 Jun 1;59(1):42-52. doi: 10.1111/j.1574-695X.2010.00660.x. Epub 2010 Feb 17.
- Derived from this study: PubMed 36560565Li J, Fu L, Guo X, Yang Y, Dong J, Wang G, Zhao A. Novel BC02 Compound Adjuvant Enhances Adaptive and Innate Immunity Induced by Recombinant Glycoprotein E of Varicella-Zoster Virus. Vaccines (Basel). 2022 Dec 15;10(12):2155. doi: 10.3390/vaccines10122155.
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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.
Tao Huang, Bachelor principal investigator
Hunan Provincial Center for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02), High-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02) and High-dose adjuvant for freeze-dried recombinant tuberculosis vaccine (AEC / BC02) in people with Tuberculosis, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 1 site 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 9 inclusion and 14 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: paused, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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 number of adverse events after intramuscular injection (time frame: Up to 6 months after the sixth time injection). 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 NCT05284812, which also lists 3 linked publications.
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 28 Nov 2023.