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

Summary

There are four populations in Recombinant Mycobacterium tuberculosis Vaccine Freeze-dried (AEC/BC02) phase I clinical research. The clinical study adopt open research design.

Population I have 25 subjects who received Tuberculin purified protein derivative(TB-PPD) skin test and specific gamma-interferon (γ-IFN)detection whose results are both negative ;Population II have 30 subjects who received Tuberculin purified protein derivative(TB-PPD) and ESAT6-CFP10 skin test in different arms , specific gamma-interferon (γ-IFN) detection whose results are all negative.We call polulation III as uninfected TB PPD positve population.This group screened 30 subjects whose ESAT6-CFP10 skin test and specific gamma-interferon (γ-IFN)detection results are both negative,but Tuberculin purified protein derivative(TB-PPD) skin test positive.50 subjects whose three kinds of detection results are all positive γ-IFN,TB-PPD and ESAT6-CFP10 ) are named as population IV.

After filtrating, injecting of population I start firstly.After ensure the safety of the population I,the population II～polulation IV carry out in turn the implementation at the same time.

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 .

Sponsors & Collaborators

• Shanghai Public Health Clinical Center

  collaborator OTHER_GOV

• Beijing Simoonrecord Pharmaceutical Information Consulting Co.,Ltd

  collaborator UNKNOWN

• Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

  lead INDUSTRY

Principal Investigators

• Shuihua Lu · Shanghai Public Health Clinical Center

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

2018-04-16

Primary Completion

2018-09-04

Completion

2019-10-30

Countries

• China

Study Locations