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More info
You can access this
clinical trial
if you have
Tuberculosis
and you are
between 18 and 55
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

The purpose of this study is to evaluate the safety profile of CAF01, administering 50 µg Ag85B-ESAT-6 alone and 50 µg Ag85B-ESAT-6 with three escalating CAF01 dose levels, to four groups of healthy volunteers, injecting two doses with two months interval.

Provided treatments

  • Biological: 50 µg Ag85B-ESAT-6 alone
  • Biological: 50 µg Ag85B-ESAT-6 + 125/25 µg CAF01
  • Biological: 50 µg Ag85B-ESAT-6 + 313/63 µg CAF01
  • Biological: 50 µg Ag85B-ESAT-6 + 625/125 µg CAF01
Tris trial is registered with FDA with number: NCT00922363. The sponsor of the trial is Statens Serum Institut and it is looking for 38 volunteers for the current phase.
Official trial title:
An Open Phase I, Dose-escalating, Clinical Trial on the Safety of a New Liposomal Adjuvant System, CAF01, When Given With the Tuberculosis Subunit Vaccine Ag85B-ESAT-6 as Two Injections With Two Months Interval to Healthy Adult Volunteers