The primary goal of this study is to evaluate the efficacy and safety of influenza, pneumococcal and hepatitis B vaccination in patients with rheumatic autoimmune diseases treated with immunosuppressive therapy compared to healthy controls. The…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Increase in titer of:
- Haemagglutination inhibition test for influenza
- ELISA for pneumococcal
- ELISA for hepatitis B
Secondary outcome
- Potential adverse events
- Disease activity
Background summary
Patients with rheumatic autoimmune disorders often require therapy with agents
that potentially compromise the immune response and subsequently increase the
risk for morbidity and mortality due to infections. Influenza and pneumococcal
vaccination is therefore indicated in these patients, but often forgotten.
The disease itself and immunosuppressive therapy may influence the response to
vaccination. However, little is known about this influence. Therefore, in this
study we want to investigate the response to vaccination during
immunosuppressive therapy. This may lead do adjustments to the current
vaccination policy.
Study objective
The primary goal of this study is to evaluate the efficacy and safety of
influenza, pneumococcal and hepatitis B vaccination in patients with rheumatic
autoimmune diseases treated with immunosuppressive therapy compared to healthy
controls.
The secondary goal of this study is to evaluate the efficacy of a two-dose
vaccination regimen of influenza vaccination in patients with rheumatic
autoimmune diseases treated with immunosuppressive therapy.
Study design
In this open-label study the response to influenza, pneumococcal and hepatitis
B vaccination will be investigated in patients with rheumatic autoimmune
diseases treated with immunosuppressive therapy. This response will be compared
with the response to these vaccinations in healthy controls. The response to a
second influenza vaccination will also be examined in the patients. The
response to influenza vaccination is T cell dependent and the response to
pneumococcal vaccination is T cell independent with stimulation of B cells. A
part of the patients with rheumatic autoimmune disorders will have received
these vaccinations prior to start of this study. Hepatitis B vaccination is
chosen to investigate the response to a de-novo antigen. The response to
influenza vaccination will be assessed by a haemagglutination inhibition test.
The response to pneumococcal and hepatitis B vaccination will be assessed by
standard ELISAs (enzyme-linked immunosorbent assays). In total 90 patients will
be included in the study: 30 treated with rituximab, 30 treated with TNFα
blocking agents and 30 treated with traditional DMARDs. The responses of these
patients will be compared with the response to the same vaccinations in 30
healthy controls.
Study burden and risks
Burden patients:
- Drawing of extra blood samples (in total 4 times, total 40 ml blood).
- Extra time investment (5 times of 30 minutes = 2,5 hours).
- Extra hospital visits (about 2-3 times).
Burden healthy controls:
- Drawing of extra blood samples (in total 2 times, total 20 ml blood).
- Extra time investment (2 times 15 minutes = 0,5 hour).
- Extra hospital visit (1 time).
Risks:
- Venapunction: adverse events are rare.
- Intramuscular injections: most people will not experience adverse events.
Mild local reactions at the injection site may occur (including pain, mild
redness, swelling, bruises and a stiff arm). Sometimes systemic side effects
occur, including fever, chills, sweating, malaise, tiredness and muscle or
joint pain. The complaints often resolve within 1 to 2 days without
intervention. Serious side effects are rare.
Geert Grooteplein 8
6525 GA Nijmegen
Nederland
Geert Grooteplein 8
6525 GA Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
In general: willing to give written informed consent.
Per group:
1. Patients with rheumatic autoimmune diseases, including rheumatoid arthritis, poly or dermatomyositis, systemic lupus erythematosus, Sjögren*s syndrome, treated with rituximab within 3-9 months prior to start of the study with or without concomitant treatment with traditional DMARDs and/or corticosteroids.
2. Patients with rheumatic autoimmune diseases, including rheumatoid arthritis, poly or dermatomyositis, systemic lupus erythematosus, Sjögren*s syndrome, treated with TNFα blocking agents as single therapy or combined with DMARDs and/or corticosteroids on stable therapy of 3 or more months.
3. Patients with rheumatic autoimmune disease, including rheumatoid arthritis, poly or dermatomyositis, systemic lupus erythematosus, Sjögren*s syndrome, on stable therapy with only traditional DMARDs and/or corticosteroids for 3 or more months.
4. Age and gender matched healthy controls
Exclusion criteria
- Age under 18 years
- No informed consent
- Pregnancy
- History of vaccination allergy
- Known allergy to egg products
- Patients known with positive hepatitis B serology
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 |
|---|---|
| EudraCT | EUCTR2007-005309-23-NL |
| CCMO | NL19268.000.07 |