A Phase Ⅱ Clinical Trial of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried (AEC/BC02)
NCT ID: NCT05284812
Last Updated: 2023-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
SUSPENDED
PHASE2
200 participants
INTERVENTIONAL
2022-02-10
2024-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Negative control population group
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.
No interventions assigned to this group
Sentinel group
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 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
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
Low-dose group
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.
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
High-dose group
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.
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
3 dose of High-dose group
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.
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
Lyophilized recombinant tuberculosis vaccine (AEC / BC02) placebo
Subjects receive Lyophilized recombinant tuberculosis vaccine (AEC / BC02) placebo injection into the deltoid muscle of the upper arm
Placebo group
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.
Lyophilized recombinant tuberculosis vaccine (AEC / BC02) placebo
Subjects receive Lyophilized recombinant tuberculosis vaccine (AEC / BC02) placebo injection into the deltoid muscle of the upper arm
Adjuvant group
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.
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
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
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
Lyophilized recombinant tuberculosis vaccine (AEC / BC02) placebo
Subjects receive Lyophilized recombinant tuberculosis vaccine (AEC / BC02) placebo injection into the deltoid muscle of the upper arm
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. I agree to participate in this study and sign the informed consent;
3. I can complete the whole process of clinical research in accordance with the requirements of the clinical research program;
4. 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;
5. 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;
6. 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;
7. Laboratory tests including blood routine, urine routine, blood biochemistry and other tests are all normal or have no clinical significance;
8. There is no abnormality in the electrocardiogram examination or the abnormality has no clinical significance;
9. Those who have no history of tuberculosis after medical history inquiry.
Exclusion Criteria
2. There are serious chronic diseases or the disease is in the advanced stage and cannot be controlled smoothly, such as diabetes and thyroid disease;
3. 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.;
4. 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;
5. Existing mental/neurological diseases or history of mental/neurological diseases: those with convulsions, epilepsy, encephalopathy, or family history of mental illness;
6. Those who currently suffer from biliary obstruction;
7. 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;
8. Patients with severe liver insufficiency, or patients with drug-induced hepatitis and acute liver disease caused by any cause;
9. Difficulty swallowing, active or clinically significant digestive system diseases, and affecting drug absorption;
10. Current patients with active viral hepatitis and/or HIV antibody positive for human immunodeficiency virus and/or current or past syphilis;
11. 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;
12. 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;
13. Those who have participated in any other clinical research and used the investigational drug within 3 months before this clinical research;
14. Any other situation that the researcher believes may affect the evaluation of the research.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tao Huang, Bachelor
Role: PRINCIPAL_INVESTIGATOR
Hunan Provincial Center for Disease Control and Prevention
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hunan Provincial Center for Disease Control and Prevention
Changsha, Hunan, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Pulendran B, Ahmed R. Immunological mechanisms of vaccination. Nat Immunol. 2011 Jun;12(6):509-17. doi: 10.1038/ni.2039.
Chen 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.
Li 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LKM-2021-BJH01
Identifier Type: -
Identifier Source: org_study_id