NCT05284812

A Phase Ⅱ Clinical Trial of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried (AEC/BC02)

A Phase Ⅱ Study on the Safety, Tolerability and Immunogenicity of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 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

Interventions

Type	Name	Description
BIOLOGICAL	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	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	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	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

Timeline

• Start date: 2022-02-10
• Primary completion: 2024-06-30
• Completion: 2024-12-31
• First posted: 2022-03-17
• Last updated: 2023-11-28

Locations

1 site across 1 country: China