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

NCT05284812 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-11-28

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Tao Huang, Bachelor · Hunan Provincial Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-10
Primary Completion
2024-06-30
Completion
2024-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05284812 on ClinicalTrials.gov