drugset / Trial / NCT00922363

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

NCT00922363

Phase 1 Completed 38 enrolled Statens Serum Institut
Non-randomizedParallel-groupOpen-labelPrevention

Summary

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.

Timeline

Start
2009-10
Primary completion
2011-10
Completion
2011-10

Drugs

EvaluationDrugModalityDoseRoute
Subject AFO-18 Vaccine 25 ug
Subject AFO-18 Vaccine 63 ug
Subject AFO-18 Vaccine 125 ug
Subject AFO-18 Vaccine 313 ug
Subject AFO-18 Vaccine 625 ug
Background Ag85B-ESAT-6 Vaccine 50 ug

Indications