BCG vaccination / immune respons
Conditions
Interventions
Trade Name: RVG 17661
Product Name: BCG vaccination
Product Code: BCG 1331
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: BCG vaccine
Concentration unit: ml millilitre(s)
Concentra
Sponsors
LUMC, Department Infection Disease
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy Age 18-55 year Naieve tuberculose volunteers (negaitve TST and negative QFN-test) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: History of TB disease or treatment BCG vaccination HIV-positive Pregancy breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective is to characterize the anti-mycobacterial immune responses during vaccination with live-attenuated M.Bovis BCG Danish strian 1331, in order to provide a framework for using biomarkers in future TB vaccine trials.;Secondary Objective: To evaluate wheter biomarkers, specific for BCG can be detected in the circulations and in the urine following vaccination. ;Primary end point(s): Vaccine induced changes in the antigen-specific immune response and in BCG-specific biomarkers following vaccination with BCG Changes in biomarkers for T-cells;Timepoint(s) of evaluation of this end point: 2014 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Vaccine induced changes in the antigen-specific immune response and in BCG-specific biomarkers following vaccination with BCG Changes in biomarkers for T-cells;Timepoint(s) of evaluation of this end point: 2014 | — |
Countries
Netherlands
Contacts
Public ContactDepartment of Infection Disease
Leids Universitair Medisch Centrum
Outcome results
None listed