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ID
Source
Brief title
Health condition
hepatits A
vaccination
immunosuppression
Hepatitis A
vaccinatie
immuunsuppressie
Sponsors and support
fund=initiator=sponsor
fund=initiator=sponsor
Intervention
Outcome measures
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.
Background summary
Travelers 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.
Study objective
An extra booster vaccination will improve efficacy of hepatitis A vaccination in travellers using immunosuppressive medication.
Study design
preparation 3 months
inclusion 18 months
follow-up 24 months
Intervention
Boostervaccination of hepatitis A 2 weeks after first vacciantion.
Department of Medical Microbiology <br>
PO Box 5800
A. Verbon
Maastricht 6202 AZ
The Netherlands
+31 (0)43 3876644
a.verbon@mumc.nl
Department of Medical Microbiology <br>
PO Box 5800
A. Verbon
Maastricht 6202 AZ
The Netherlands
+31 (0)43 3876644
a.verbon@mumc.nl
Inclusion criteria
1. 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-รก 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 criteria
1. Allergy to the advised vaccine or its components.
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 | NL677 |
| NTR-old | NTR1522 |
| Other | : |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |