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More info
You can access this
clinical trial
if you have
Tuberculosis
and you are
between 18 and 45
years old
1
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