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.
Primary Indication: Prevention of TB disease
Target Population(s): Adults, Elderly, and People with Mtb infection
Clinical Trials
ACTIVE TRIALS |
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| Registry Number | NCT05284812 |
| 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)