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

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

November 30, 2005

Primary Completion Date

March 31, 2008

Study Completion Date

June 30, 2008

Conditions
Tuberculosis
Interventions
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

Trial Locations (1)

2300

Leiden University Medical Centre, Leiden

All Listed Sponsors
lead

Statens Serum Institut

OTHER

NCT01003093 - A Safety and Immunogenicity Trial With an Adjuvanted Tuberculosis(TB) Subunit Vaccine | Biotech Hunter | Biotech Hunter