No registrations found.
ID
Source
Brief title
Health condition
local pain, irritation or discomfort at the injection site (immediately after the injection)=common
uncommon= headache, fever local; enlargement of regional lymph node >1cm. Ulceration with a severe discharging ulcer at the site of injection.
Rare: disseminated BCG complications such as osteitis or osteomyelitis, allergic reactions, including anaphylactic reactions. Local suppurative lymphadenitis, abscess formation.
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
to evaluate whether biomarkers, specific for BCG can be detected in the circulation and in the urine following vaccination.
Background summary
Tuberculosis is a growing global health problem. The only available vaccine is Bacille Calmette-Querin (BCG). It protects young childeren from severe forms of tuberculosis, but it is of limited value in adults.We hypothesize that the antigen expression profile of BCG during intradermal vaccination is different form that of Mycobacterium tuberculosis. The partial failure of BCG may be related to this difference.
Study objective
THE LACK OF PROTECTION BY BCG MAY BE THE CONSEQUENCE OF REGULATORY T CELL INDUCTION OR ACTIVATION. SECONDLY, RECOGNITION OF MYCOBACTERIAL ANTIGENS MAY BE DIFFERENT AFTER INFECTION AND VACCINATION.
Study design
heparine blood, (paxgene, serum): -2 week, 0, +1 day, +3 day, +7 day, 4, 8, 12, 52 weeks
Urine sample: -2 week, +1, +3, +7, 8 weeks
QFN; -2 weeks
Intervention
BCG VACCINE SSI (DANISH STRAIN 1331; RVG NUMBER 17661)
[default]
The Netherlands
[default]
The Netherlands
Inclusion criteria
HEALTHY
AGE 18-55 YEAR
SIGNED WRITTEN INFORMED CONSENT
NAIVE FOR TUBERCULOSE (NEGATIVE TST AND NEGATIVE QFN)
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4101 |
| NTR-old | NTR4245 |
| Other | : BCG-study |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |