Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2026-01-17 @ 10:22 AM
Study NCT ID:
NCT05284812
Status:
SUSPENDED
Last Update Posted:
2023-11-28
First Post:
2022-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase Ⅱ Clinical Trial of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried (AEC/BC02)
Sponsor:
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase Ⅱ Study on the Safety, Tolerability and Immunogenicity of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried
Status:
SUSPENDED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
It is planned to restart the clinical study after the completion of the clinical trial protocol modification.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: