To determine whether a second, booster, influenza vaccination leads to a higher seroprotection rate in SLE patients, as compared to a single vaccination.
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Seroprotection rate (the percentage of SLE patients with a titre equal to or
greater than 40 against all three vaccine strains) in SLE patients after two
influenza vaccinations as compared to a single vaccination.
Secondary outcome
1. Seroconversions and fourfold titre rises after 4 weeks and after 8 weeks.
2. Geometric mean titres after four weeks and after 8 weeks
Background summary
Systemic lupus erythematosus (SLE) is an autoimmune disease, patients are often
treated with immunosuppressive drugs to control disease activity. This causes
patients to be susceptible for infections, like influenza. Former research
showed influenza vaccination to be safe in SLE, however fewer patients reached
protective titres as compared to healthy controls. It is desirable to increase
this seroprotection rate. A second, booster vaccination, administered 4 weeks
after the first vaccination is a possible approach to achief a higher
seroprotection rate.
Study objective
To determine whether a second, booster, influenza vaccination leads to a higher
seroprotection rate in SLE patients, as compared to a single vaccination.
Study design
Fifty-two SLE patients and 30 healthy controls will be included. Patients will
receive an influenza vaccination in October - December 2007. Four weeks later
a second, booster, vaccination will be given. Healthy controls will receive a
single vaccination, in October - December 2007. Evaluation of titres will be
done before vaccination and four weeks following the first vaccination. In
patients a second titre evaluation will be done four weeks after the second
vaccination.
Intervention
Administration of a trivalent subunit influenza vaccine: Influvac. In SLE
patients this vaccine will be given for a second time, four weeks after the
first vaccination.
Study burden and risks
Patients
Receiving an influenza vaccination gives SLE patients a good chance to have
sufficient protection against influenza in the following influenza season. The
non-regular outpatient visit after 28 days is a burden, furthermore a total of
30 ml of blood will be drawn. The adverse effects of influenza vaccination are
usually mild, though SLE patients have to experience an extra time.
Healthy controls
Influenza vaccination will be done as part of the hospital campaign to
vaccinate health care workers. Therefore this is not an extra burden. Two times
10 ml of blood will be drawn, which is considered as a small burden.
Postbus 30.001
9700 RB Groningen
Nederland
Postbus 30.001
9700 RB Groningen
Nederland
Listed location countries
Age
Inclusion criteria
Patients
- patients have to fulfil international disease criteria of SLE
- quiescent disease, defined as SLEDAI <=5
- informed consent;Healthy controls
- informed consent
Exclusion criteria
Patients
- active disease, defined as SLEDAI >5
- use of prednisone >30 mg/day
- pregnancy
- malignancy
- no informed consent;Healthy controls
- use of immunosuppressives
- malignancy
- pregnancy
- no informed consent
Design
Recruitment
Medical products/devices used
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 | EUCTR2007-004579-21-NL |
| CCMO | NL18929.042.07 |