Prevention Tuberculosis
Conditions
Interventions
two times a vaccination within two months, intramuscularly into deltoid muscle.
Sponsors
Statens Serum Institut
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: BCG-group: BCG-vaccinated > two years before, PPD+ (range 6-15mm) or any documented value between 6-15mm on medical file in the past, with no active, chronic or past TB disease as confirmed by chest X ray, negative Quantiferon-TB gold in Tube test and negative 6-day lymphocyte tests;Infection-group: known to be diagnosed with latent TB, PPD+, previously TB infected but with no active disease confirmed by chest X ray, may have received chemoprophylaxis but with no TB treatment/chemoprophylaxis within the preceding 2 years, positive Quantiferon-TB Gold In Tube test and or positive 6-day lymphocyte test Healthy based on medical examination/history at the inclusion Age between 18 and 55 ears Signed informed consent
Exclusion criteria
Exclusion criteria: Granulomatous disease other then TB Vaccinated with live vaccine 3 months before the first vaccination Administration of immune modilating drugs 3 months before first vaccination HBV, HCV, or HIV sero-positive Participation in another clinical trial Known hypersensitivity to any of the vaccine components Laboratory parameters outside of normal range judged by PI to be clinically relevant Pregnant women/planned pregnancy and/or breastfeeding within the trail period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary variables: A. Physical examination, including ENT, cardiovasculair, pulmonary, neurological, gastrointestinal, urogenital and dermatological systems, as well as injection sites B. Local adverse events, including pain, erythema, urticaria, asthma, angiooedema, fatigue, fever, arthralgia, myalgia, hoarseness, dizziness, malaise, paleness, sweating, nausea, arrhytmia, headache and anaphylaxis Laboratory safett tests: D. Blood samples will be tested for RBC, differential WBC, platelets, hemoglobin, hematocrit, ASAT, ALAT, alkaline phosphatase, lactate dehydrogenase, gamma GT, albumin, bilirubin, creatine, glucose, potassium, sodium E. Urine samples will be tested for glucose, protein and sediment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary variables: A. Detection by elispot of IFN-gamma spot-forming cells in PBMC's after stimulation with Ag85B, Esat-6 and H1 B. Detection by ELISA of IFN-gamma production in supernatants of PBM stimulated with Ag85B, ESAT and H1. C. Detection by ELISA of IgG antibodies to recombinant proteins Ag85B, ESAT-6 and H! in serum/plasma. D. Detection by ELISA of TNF-gamma in serum before and one day after vaccination. Quantiferon TB-Gold In Tube Test | — |
Countries
Netherlands
Outcome results
None listed