Prevention Tuberculosis
Conditions
Interventions
Two vaccinations over a two month period, intramuscularly into deltoid muscle.
Sponsors
Statens Serum Institut
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Female and male (18-55 years) Healthy
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety variables: - Adverse reactions with onset between the first vaccination and 24 weeks after the second vaccination either identified during medical examinations, as diary records, or during safety interviews - Changes form baseline in safety laboratory test values 1 day, 7 days and 6 weeks after the first and second vaccinations and 24 weeks after the second vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity variables - Changes from baseline in Ag85B-Esat-6 induced IFN-gamma release from PBMC's measured by ELISA, 1 week and 6 weeks after the first and second vaccinations and 24 and 44 weeks after the second vaccination. - Changes from baseline in Ag85B-ESAT6 IFN-gamma spot forming cells measured by ELISPOT, 1 week and 6 weeks after the first and second vaccinations and 24 and 44 weeks after the second vaccination. - Changes from baseline in serum Ig-G antibodies against Ag85B-ESAT-6, 6 weeks after the first and second vaccinations and 24 and 44 weeks after the second vaccination. | — |
Countries
Netherlands
Outcome results
None listed