AEC/BC02

Phase of Development

Phase 2a

Vaccine Platform

Protein / Adjuvant

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
_________________________
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)