AEC/BC02
Candidate Overview
AEC/BC02 is made from the Ag85b protein and ESAT6-CFP10 protein expressed by recombinant Escherichia coli as the active antigen component (AEC) and the complex adjuvant system (BC02) composed of cytosine guanine dinucleotide (BCG-cpg-DNA) and aluminum hydroxide of BCG.
Sponsor / Lead Developer: Anhui Zhifei Longcom Biopharmaceutical Co., Ltd.
Clinical Trial Status: Active Trials
Primary Indication: Prevention of TB disease
Target Population(s): Adults, Elderly, and People with Mtb infection
Clinical Trials
ACTIVE TRIALS |
|
| Registry Number | NCT05284812 (SUSPENDED) |
| Clinical Trial Phase | Phase 2a |
| Clinical Trial Sponsor | Anhui Zhifei Longcom Biologic Pharmacy Co, Ltd. |
| Primary endpoint(s) for this clinical trial | Safety |
| Target population(s) for clinical trial | Adults |
| Elderly | |
| People with Mtb infection | |
COMPLETED TRIALS |
|
| Registry Number | NCT04239313 |
| Clinical Trial Phase | Phase 1 |
| Clinical Trial Sponsor | Anhui Zhifei Longcom Biologic Pharmacy Co, Ltd. |
| Primary endpoint(s) for this clinical trial | Safety |
| Target population(s) for clinical trial | Adults |
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|
| Registry Number | NCT03026972 |
| Clinical Trial Phase | Phase 1 |
| Clinical Trial Sponsor | Anhui Zhifei Longcom Biologic Pharmacy Co, Ltd. |
| Primary endpoint(s) for this clinical trial | Safety |
| Target population(s) for clinical trial | Adults |
Related Publications
- Therapeutic evaluation of antibiotics combined with recombinant tuberculosis vaccine AEC/BC02 in a guinea pig model of Mycobacterium tuberculosis infection (Chin J Microbiol Immunol, 2018, Chinese)
- Therapeutic evaluation of isoniazid in combination with recombinant tuberculosis vaccine AEC/BC02 in guinea pigs infected with Mycobacterium tuberculosis (Chin J Antibuberc, 2017, Chinese)
- 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)
Additional Information
The Phase 2a trial is temporarily suspended. Per the registry listing in ClinicalTrials.gov “It is planned to restart the clinical study after the completion of the clinical trial protocol modification.”