NCT00929396

A Safety and Immunogenicity Trial With an Adjuvanted Tuberculosis (TB) Subunit Vaccine in Purified Protein Derivative (PPD) Positive Volunteers

A Safety and Immunogenicity Phase 1 Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31)Administered in PPD Positive Volunteers at 0 and 2 Months

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (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 an adjuvanted TB subunit vaccine administered at 0 and 2 months.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
BIOLOGICAL	50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)	o,5 mL suspension for injection x 2 with 2 months interval
BIOLOGICAL	50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)	o,5 mL suspension for injection x 2 with 2 months interval

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2009-06-29
• Last updated: 2013-01-21

Locations

1 site across 1 country: Netherlands