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IMMUNE RESPONSE INDUCED BY VACCINATION WITH BCG


- candidate number15603
- NTR NumberNTR4245
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-okt-2013
- Secondary IDsBCG-study 
- Public TitleIMMUNE RESPONSE INDUCED BY VACCINATION WITH BCG
- Scientific TitleIMMUNE RESPONSE INDUCED BY VACCINATION WITH BCG
- ACRONYMBCG-VACCIN
- hypothesisTHE 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.
- Healt Condition(s) or Problem(s) studied
- Inclusion criteriaHEALTHY
AGE 18-55 YEAR
SIGNED WRITTEN INFORMED CONSENT
NAIVE FOR TUBERCULOSE (NEGATIVE TST AND NEGATIVE QFN)
- Exclusion criteriaHISTORY 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-okt-2012
- planned closingdate1-dec-2014
- Target number of participants25
- InterventionsBCG VACCINE SSI (DANISH STRAIN 1331; RVG NUMBER 17661)
- Primary outcometo 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 outcometo evaluate whether biomarkers, specific for BCG can be detected in the circulation and in the urine following vaccination.
- Timepointsheparine 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
- Trial web siteN/A
- status[default]
- CONTACT FOR PUBLIC QUERIES
- CONTACT for SCIENTIFIC QUERIES
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryTuberculosis 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.
- Main changes (audit trail)
- RECORD29-okt-2013 - 19-nov-2013


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