A Safety and Immunogenicity Trial With an Adjuvanted Tuberculosis(TB) Subunit Vaccine
Phase 1
Completed
- Conditions
- Tuberculosis
- Registration Number
- NCT01003093
- Lead Sponsor
- Statens Serum Institut
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 36
Inclusion Criteria
- Male
- Healthy based on medical examination/history at the inclusion
- Age between 18 and 55 years
- Signed informed consent
- Prepared to grant authorized persons access to the medical records
- The volunteer is likely to comply with instructions
Exclusion Criteria
- Known exposure to TB before (or expected during) the trial
- Prior BCG vaccination
- Granulomatous disease (by chest X-ray, autoimmune screen)
- Vaccinated with live vaccine 3 months before first vaccination
- Administration of immune modulating drugs (steroids, immunosuppressive drugs or immunoglobulins) 3 months before the first vaccination
- HBV, HCV or HIV sero-positive (HBsAg, HBsAb, HBc total and IgM ab and HCV, HIV-1 and HIV2 ab)
- Participation in other clinical trials
- Positive Mantoux or QuantiFERON-TB Gold
- Known hypersensitivity to any of the vaccine components
- Laboratory parameters outside of normal ranges considered clinically relevant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Physical examination. Local adverse events. Systemic adverse events. Laboratory safety tests including urine safety tests. From the first vaccination until 8 months after the first vaccination
- Secondary Outcome Measures
Name Time Method Detection by ELISPOT of IFN gamma spot-forming cells in PBMC. Detection by ELISA of IFN gamma production in supernatants of PBMC. Detection of humoral response (IgG) by ELISA. From first vaccination until 36 months after first vaccination
Trial Locations
- Locations (1)
Leiden University Medical Centre
🇳🇱Leiden, RC Leiden, Netherlands
Leiden University Medical Centre🇳🇱Leiden, RC Leiden, Netherlands