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Intradermal Hepatitis-B-vaccination in non-responders after application of imiquimod 5% at the site of vaccination.


- candidate number2716
- NTR NumberNTR1043
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-aug-2007
- Secondary IDsWordt nog doorgegeven 
- Public TitleIntradermal Hepatitis-B-vaccination in non-responders after application of imiquimod 5% at the site of vaccination.
- Scientific TitleIntradermal Hepatitis-B-vaccination in non-responders after topical application of imiquimod 5%.
- ACRONYMN/A
- hypothesisImiquimod stimulates dendritic cell antigen presentation and migration to lymphnodes. Since dendritic cells are present in the dermis and epidermis, vaccination in the dermis could target these cells and, with simultaneous topical imiquimod treatment elicit an immune response in previously non-responders to hepatitis B vaccination.
- Healt Condition(s) or Problem(s) studiednon-responsiveness to hepatitis B vaccination
- Inclusion criteria1. >18 yrs;
2. Minimal 2 series of Hepatitis B vaccination (= minimal 6 intramuscular injections of 10microgr recombinant hepatitis B vaccine) with antibody titre <10IU/ml.
- Exclusion criteria1. Carrier of hepatitis B virus;
2. Known immunosuppressive state due to illness or medication;
3. Autoimmune disorder;
4. Pregnancy.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlPlacebo
- groupParallel
- Type[default]
- Studytypeintervention
- planned startdate 1-mei-2007
- planned closingdate1-mei-2008
- Target number of participants26
- InterventionsIntradermal hepatitis B vaccination with recombinant vaccine after topical treatment with imiquimod 5% cream
- Primary outcomeSerologic response after vaccination
- Secondary outcomeAdverse events Cellular immunity
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. A.H.E. Roukens
- CONTACT for SCIENTIFIC QUERIESMD. PhD. L.G. Visser
- Sponsor/Initiator Leiden University Medical Center (LUMC), Department of Infectious Diseases
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC), Department of Infectious Diseases
- Publications
- Brief summaryIn this trial we investigate whether intradermal Hepatitis B vaccination in previously non-responders elicit an antibody response after application of imiquimod 5% at the site of vaccination.
- Main changes (audit trail)
- RECORD31-aug-2007 - 6-mrt-2008


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