1. a. Does influenza vaccination in SLE and Wegener patients result in a decreased humoral immune response compared to healthy age-matched controls?; b. Does influenza vaccination in SLE and Wegener patients result in a decreased cellular immune…
ID
Bron
Verkorte titel
Aandoening
1. Systemic lupus erythematosus;
2. Wegener's granulomatosis.
Ondersteuning
2. J.K. de Cock Foundation, the Netherlands;<br>
3. Solvay Pharmaceuticals, the Netherlands.
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Antibody response to vaccination:<br> seroprotection rate, fourfold titre rises and geometric mean titres.
Achtergrond van het onderzoek
Influenza vaccination in patients with systemic lupus erythematosus (SLE) and Wegener's granulomatosis (WG) seems indicated, as they are at increased risk for infections and have a higher risk of morbidity and mortality following influenza infection. However, questions regarding safety and efficacy of vaccination remain.
In this study we will address the questions concerning safety and immunogenicity of influenza vaccination in our (immuno-suppressed) cohorts of SLE and WG patients. Patients with different immuno-suppressive regimes will be vaccinated and disease activity and antibody response will be monitored thereafter.
Patients will be randomized to receive either a vaccination or to participate as patient control. Furthermore a group of healthy controls will be vaccinated. Follow-up will be at 1 month and 3-4 months following vaccination.
Primary outcomes is the antibody response to vaccination, secondary outcomes are disease activity as measured by disease activity indexes and cell-mediated immune responses to influenza.
Doel van het onderzoek
1. a. Does influenza vaccination in SLE and Wegener patients result in a decreased humoral immune response compared to healthy age-matched controls?;
b. Does influenza vaccination in SLE and Wegener patients result in a decreased cellular immune respons compared to healthy age-matched controls?;
c. Do different immuno-suppressive therapies in these patients influence the immune responses after vaccination?;
2. Does influenza vaccination in SLE and Wegener patients increase disease activity?
Onderzoeksopzet
t = 0
t = 1 month
t = 3-4 months
Onderzoeksproduct en/of interventie
Influenza vaccination.
Publiek
University Medical Center Groningen, University of Groningen
PO Box 30.001
A. Holvast
Groningen 9700 RB
The Netherlands
31) 50-3612945,
B.Holvast@int.umcg.nl
Wetenschappelijk
University Medical Center Groningen, University of Groningen
PO Box 30.001
A. Holvast
Groningen 9700 RB
The Netherlands
31) 50-3612945,
B.Holvast@int.umcg.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Patients have to fulfil international disease criteria of SLE or WG;
2. quiescent disease, defined as SLEDAI under 6 or BVAS under 2;
3. informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
SLE patients are not eligible for the study in case of:
1. active disease, defined as SLEDAI >5;
2. a yearly influenza vaccination is concerned mandatory by the patient's physician;
3. use of prednisone >30 mg/day;
4. pregnancy;
5. no informed consent.
WG patients are not eligible for the study in case of:
1. active disease, defined as BVAS >1;
2. a yearly influenza vaccination is concerned mandatory by the patient's physician;
3. use of prednisone >30 mg/day;
4. use of cyclofosfamide >100 mg/day;
5. pregnancy.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1096 |
| NTR-old | NTR1130 |
| Ander register | Medical Ethics Committee - University Medical Center Groningen : 2005-147 |
| ISRCTN | Wordt niet aangevraagd/retrospectief onderzoek |