No registrations found.
ID
Source
Brief title
Health condition
1. Systemic lupus erythematosus;
2. Wegener's granulomatosis.
Sponsors and support
2. J.K. de Cock Foundation, the Netherlands;<br>
3. Solvay Pharmaceuticals, the Netherlands.
Intervention
Outcome measures
Primary outcome
Antibody response to vaccination:
seroprotection rate, fourfold titre rises and geometric mean titres.
Secondary outcome
1. safety: changes in disease activity in terms of SLEDAI (systemic lupus erythematosus) or BVAS (Wegener's granulomatosis).
2. Effect of immunosuppressive drugs on antibody responses to vaccination
3. cell-mediated responses to influenza (vaccination)
Background summary
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.
Study objective
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?
Study design
t = 0
t = 1 month
t = 3-4 months
Intervention
Influenza vaccination.
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
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
Inclusion criteria
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.
Exclusion criteria
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.
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 | NL1096 |
| NTR-old | NTR1130 |
| Other | Medical Ethics Committee - University Medical Center Groningen : 2005-147 |
| ISRCTN | Wordt niet aangevraagd/retrospectief onderzoek |