NCT01049282

A Safety and Immunogenicity Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31)

A Safety and Immunogenicity Phase 1 Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31) Administered in Different Antigen/Adjuvant Formulations in TST Negative and TST Positive Volunteers at 0 and 2 Months

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Statens Serum Institut · Academic / Other
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The study has the following objectives: Primary objective To evaluate the safety profile of an adjuvanted TB subunit vaccine administered in different antigen/adjuvant formulations at 0 and 2 months Secondary objective To determine the immunogenicity profile of an adjuvanted TB subunit vaccine administered in different antigen/adjuvant formulations at 0 and 2 months.

Detailed description

Number of trial subjects=48 Investigational product=Ag85B - ESAT-6 + IC31 Dosage Group 1: TST negative, 50 µg antigen Group 2: TST negative, 50 µg antigen + fixed adjuvant Group 3: BCG vaccinated, 50 µg antigen + fixed adjuvant Group 4 : Latent TB, 50 µg antigen + fixed adjuvant Dosage volume 0.5 ml Administration Intramuscularly into deltoid muscle, alternate arms at day 0 (right) and day 56 (left).

Conditions

• Tuberculosis

Interventions

Type	Name	Description
BIOLOGICAL	Antigen (Ag85B-ESAT-6)	Solution for injection, 0.5 mL, 50 ug antigen, 2 vaccinations with 2 months interval
BIOLOGICAL	Antigen (Ag85B-ESAT-6) with adjuvant (IC31)	Suspension for injection, 0.5 mL, 50 ug antigen, 2 vaccinations with 2 months interval

Timeline

• Start date: 2008-12-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2010-01-14
• Last updated: 2015-04-17