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Efficacy of hepatitis A vaccination in immunocompromised travelers.


- candidate number4335
- NTR NumberNTR1522
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-nov-2008
- Secondary IDs 
- Public TitleEfficacy of hepatitis A vaccination in immunocompromised travelers.
- Scientific TitleEfficacy of hepatitis A vaccination in immunocompromised travelers.
- ACRONYMHEPAVIT
- hypothesisAn extra booster vaccination will improve efficacy of hepatitis A vaccination in travellers using immunosuppressive medication.
- Healt Condition(s) or Problem(s) studiedImmunocompromized patients, Vaccination, Hepatitis A
- Inclusion criteria1. All consecutive patients > 18 years of age using immunosuppressive medication who come to the travel clinics and need vaccination with hepatitis A according to LCR guidelines.
- Immunosuppressive medication is defined as use of cyclosporine A, azathioprine, cyclophosphamide, methotrexate, TNF- blockers, prednisone use eqal to 10 mg/day or a cumulative dose of > 700 mg., tacrolimus, mycophenolate mofetil.

The study group will be compared with travelers > 18 years old that are immunocompetent.
- Exclusion criteria1. Allergy to the advised vaccine or its components.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-mrt-2009
- planned closingdate1-mrt-2013
- Target number of participants600
- InterventionsBoostervaccination of hepatitis A 2 weeks after first vacciantion.
- Primary outcome- Antibody titres after booster vaccination.
- Secondary outcome- Antibody titres after first hepatitis A vaccination
- Antibody production after the booster vaccination for hepatitis A
- Determination of disease or medication related and demographic parameters that are predictive for decreased antibody production to hepatitis A vaccination.
- Timepointspreparation 3 months
inclusion 18 months
follow-up 24 months
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. A. Verbon
- CONTACT for SCIENTIFIC QUERIESDr. A. Verbon
- Sponsor/Initiator University Hospital Maastricht (AZM)
- Funding
(Source(s) of Monetary or Material Support)
University Hospital Maastricht (AZM)
- PublicationsN/A
- Brief summaryTravelers who take immunosuppressive medication have a substantially increased risk of infection compared to the normal population and are thus candidates for preventive measures such as vaccination.
However, immunosuppression often alters the efficacy of vaccination. The antibody titres may be insufficient and even when sufficient may drop more quickly. When no protective antibodies are present after vaccination, the immunocompromised patient may become infected leading to spread of the disease among the population. Therefore, in case of insufficient antibody production the traveller needs passive immunisation with immunoglobulins, which is, however, expensive, has a limited protective duration and has the risk of transmission of blood borne diseases. In this study we propose to compare standard vaccination of hepatitis A with a vaccination regime that includes a booster vaccination in travellers taking immunosuppressive medication.
- Main changes (audit trail)
- RECORD4-nov-2008 - 16-nov-2008


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