BCG vaccine tuberculosis vaccine
Conditions
Interventions
Group 1: standard dose BCG + standard dose BCG (0,1 ml intracuteneous injection
of BCG vaccin (SSI, AJ vaccines) 0.75 mg/ml)
Group 2: placebo + high dose BCG (0,1 ml intracuteneous injection of BCG v
BCG vaccin
High dose BCG vaccination
Revaccination
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Healthy. Age between 18 and 55 years old.
Exclusion criteria
Exclusion criteria: Medical history associated with immunological deficiency. History of BCG vaccination. Chronic use of systemic drugs other than oral contraceptives. Use of NSAIDS less than 4 weeks prior to the start of the study. For female subjects: a positive pregnancy test at screening. Receipt of vaccination 3 months prior to the start of the study or plans to receive any other vaccination during the study period Acute illness two weeks prior to the start of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To assess the function of monocytes measured by cytokine responses after stimulation with unrelated antigens at different timepoints a. before and after single standard BCG vaccination b. before and after BCG revaccination c. before and after high dose BCG vaccination 2. To compare cytokine responses at different timepoints a. Between standard single dose vaccination and revaccination b. Between standard single dose vaccination and high dose vaccination. 3. To compare transcription and epigenetic profiles of monocytes before and after BCG (re)vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Identifying SNP variants of genes relevant for innate immune function. Cellular metabolism of peripheral monocytes | — |
Countries
The Netherlands
Outcome results
None listed