An open phase 1, 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.
Completed
- Conditions
- Prevention10028440Tuberculosis
- Registration Number
- NL-OMON33959
- Lead Sponsor
- Statens Serum Institut
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 37
Inclusion Criteria
Female and male (18-55 years)
Healthy
Exclusion Criteria
History of tuberculosis or known exposure
Positive Tuberculin Skin Test and/or positive Quantiferon
BCG vaccination
Thyroid dysfunction
Disease affecting the lymphoid organs
ANA-titer, HBV, HCV, HIV
C-reactive protein level >50 mg/l
Live vaccine vaccination within 3 months before the first vaccination
Intake of another clinical trial product/vaccine within 3 months from the first vaccination or participation in previous clinical trials with the Ag85B-Esat-6 antigen.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method