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More info
You can access this
clinical trial
if you have
and you are
between 18 and 45
years old
This is an early phase trial to determine
the dosage and safety of the new treatment.
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The purpose

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.

Provided treatments

  • Biological: Placebo
  • Biological: Low dose adjuvant
  • Biological: High dose adjuvant
  • Biological: Low dose vaccine
  • Biological: High dose vaccine

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT03026972. The sponsor of the trial is Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. and it is looking for 25 volunteers for the current phase.
Official trial title:
A Phase ⅠStudy of the Human Body Tolerance Research of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried