A Phase ⅠStudy of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried

PHASE1CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

April 16, 2018

Primary Completion Date

September 4, 2018

Study Completion Date

October 30, 2019

Conditions
Tuberculosis
Interventions
BIOLOGICAL

Placebo

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

BIOLOGICAL

Low dose adjuvant

Population I and polulation IV are coxal muscle injection of low dose adjuvant.

BIOLOGICAL

High dose adjuvant

Population II ,Population III and Population IV are coxal muscle injection of high dose adjuvant.

BIOLOGICAL

Low dose vaccine

Population I and population IV are coxal muscle injection of low dose vaccine.

BIOLOGICAL

High dose vaccine

Population II,population III and population IV are coxal muscle injection of high dose vaccine .

Trial Locations (1)

Unknown

Shanghai Public Health clinical Center, Shanghai

All Listed Sponsors
collaborator

Shanghai Public Health Clinical Center

OTHER_GOV

collaborator

Beijing Simoonrecord Pharmaceutical Information Consulting Co.,Ltd

UNKNOWN

lead

Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

INDUSTRY

NCT03026972 - A Phase ⅠStudy of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried | Biotech Hunter | Biotech Hunter