local pain, irritation or discomfort at the injection site (immediately after the injection)=common uncommon= headache, fever local
Conditions
Interventions
BCG VACCINE SSI (DANISH STRAIN 1331
RVG NUMBER 17661)
Sponsors
Performer; University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: HEALTHY AGE 18-55 YEAR SIGNED WRITTEN INFORMED CONSENT NAIVE FOR TUBERCULOSE (NEGATIVE TST AND NEGATIVE QFN)
Exclusion criteria
Exclusion criteria: HISTORY OF TB DISEASE OR TREATMENT BCG VACCINATION LIVE VACCINATION TREATMENT WITH IMMUNE MODULATING DRUGS (HISTORY OF) DISEASE AFFECTING THE LYMPHOID ORGANS KNOWN CONGENITAL OR ACQUIRED IMMUNE DEFICIENSIES POSITIVE HIV TEST FEVER OR ANTIBIOTIC TREATMENT 2 WEEKS OR LESS PRIOR TO ENROLMENT KNOWNHYPERSENSITIVITY TO ANY OF THE VACCINE COMPONENTS POSITIVE PREGNANCY TEST AT SCREENING FEMALES NOT WILLING TO USE CONTRACEPTIVES DURING THE FIRST 8 WEEKS FOLLOWING VACCINATION, OR IF BREASTFEEDING ACTIVE PARTICIPATION IN OTHER CLINICAL TRIALS DOES NOT CONSENT TO US INFORMING THE PARTICIPANT'S GENERAL PRACTIONER OF THE BCG VACCINATION AND OF ANY UNCOMMON, RARE OR SERIOUS ADVERSE EVENTS HAS A CONDITION WHICH IN THE OPINION OF THE INVESTIGATOR IS NOT SUITABLE FOR PARTICIPATION IN THE CLINICAL TRIAL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| to evaluate whether biomarkers, specific for BCG can be detected in the circulation and in the urine following vaccination. | — |
Outcome results
None listed