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A Phase Ib Study of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried (AEC/BC02)

NCT04239313 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-09-06

No results posted yet for this study

Summary

Single-center, single-dose, placebo-controlled, open-label trials were used to evaluate the safety and immunogenicity of low-dose adjuvants and low-dose vaccines in the upper arm deltoid muscle intramuscularly in the double negative population. Thirty (PPD-QFT-) healthy adult subjects aged 18-45 were selected and divided into placebo group, low-dose adjuvant group, and low-dose vaccine group. During the test, each subject must not change groups and inoculate drugs. Every two weeks (0-2-4-6-8-10 weeks), alternately inject a dose of placebo or left and right upper arm deltoid muscles. Low-dose adjuvant or low-dose vaccine, a total of 6 doses.

Conditions

Interventions

BIOLOGICAL

Low-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02)

Population I are coxal muscle injection of low dose vaccine.

BIOLOGICAL

Low-dose adjuvant for freeze-dried recombinant tuberculosis vaccine (AEC / BC02)

Population I are coxal muscle injection of low dose adjuvant.

BIOLOGICAL

Lyophilized recombinant tuberculosis vaccine (AEC / BC02) placebo

The placebo drug contains 20mg mannitol and 10 millimole(mM) phosphate buffer(PB).population I are coxal muscle injection of placebo.

Sponsors & Collaborators

  • Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Zhaolin Huang · Wuhan infectious disease hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-27
Primary Completion
2021-02-24
Completion
2022-06-20

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 NCT04239313 on ClinicalTrials.gov