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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Statens Serum Institut · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
BIOLOGICAL	50 µg Ag85B-ESAT-6 alone	0.5 mL solution for injection x 2 (2 months interval)
BIOLOGICAL	50 µg Ag85B-ESAT-6 + 125/25 µg CAF01	0,5 mL suspension for injection x 2 (2 months interval)
BIOLOGICAL	50 µg Ag85B-ESAT-6 + 313/63 µg CAF01	0.5 mL suspension for injection x 2 (2 months interval)
BIOLOGICAL	50 µg Ag85B-ESAT-6 + 625/125 µg CAF01	0.5 mL suspension for injection x 2 (2 months interval)

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2009-06-17
• Last updated: 2013-01-21

Locations

1 site across 1 country: Netherlands