NCT01003093

A Safety and Immunogenicity Trial With an Adjuvanted Tuberculosis(TB) Subunit Vaccine

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Statens Serum Institut · Academic / Other
• Sex: Male
• 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 in healthy BCG-unvaccinated volunteers with no prior history of TB disease or known prior exposure to TB

Conditions

• Tuberculosis

Interventions

Type	Name	Description
BIOLOGICAL	50 microgram antigen (Ag85B + ESAT-6)	0.5 mL suspension for injection x 2 with 2 months interval
BIOLOGICAL	50 microgram antigen (Ag85B + ESAT-6) + 100 nmol KLK + 4 nmol ODN1a	0.5 mL suspension for injection x 2 with 2 months interval
BIOLOGICAL	50 microgram antigen (Ag85B + ESAT-6) + 500 nmol KLK + 20 nmol ODN1a	0.5 mL suspension for injection x 2 with 2 months interval

Timeline

• Start date: 2005-11-01
• Primary completion: 2008-03-01
• Completion: 2008-06-01
• First posted: 2009-10-28
• Last updated: 2013-01-21

Locations

1 site across 1 country: Netherlands