NCT04239313View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

May 27, 2020

Primary Completion Date

February 24, 2021

Study Completion Date

June 20, 2022

Conditions
Tuberculosis
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.

Trial Locations (1)

30040

Wuhan Infectious Disease Hospital, Wuhan

All Listed Sponsors
lead

Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

INDUSTRY

NCT04239313 - A Phase Ib Study of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried (AEC/BC02) | Biotech Hunter | Biotech Hunter