No registrations found.
ID
Source
Brief title
Health condition
non-responsiveness to hepatitis B vaccination (with recombinant vaccine).
Sponsors and support
L.G. Visser, MD, PhD
Intervention
Outcome measures
Primary outcome
Serologic response after vaccination
Secondary outcome
Adverse events
Cellular immunity
Background summary
In 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.
Study objective
Imiquimod 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.
Intervention
Intradermal hepatitis B vaccination with recombinant vaccine after topical treatment with imiquimod 5% cream
P.O. Box 9600
A.H.E. Roukens
Albinusdreef 2
Leiden 2300 RC
The Netherlands
a.h.e.roukens@lumc.nl
P.O. Box 9600
A.H.E. Roukens
Albinusdreef 2
Leiden 2300 RC
The Netherlands
a.h.e.roukens@lumc.nl
Inclusion criteria
1. >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 criteria
1. Carrier of hepatitis B virus;
2. Known immunosuppressive state due to illness or medication;
3. Autoimmune disorder;
4. Pregnancy.
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 | NL1014 |
| NTR-old | NTR1043 |
| Other | : Wordt nog doorgegeven |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |