Does booster influenza vaccination improve vaccination efficacy in patients with quiescent systemic lupus erythematosus?

Does booster influenza vaccination improve vaccination efficacy in patients with quiescent systemic lupus erythematosus? - n.v.t.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31124

Enrollment

Registered

2007-08-24

Start date

2007-09-27

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

systemische lupus erythematosus

Interventions

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.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients - patients have to fulfil international disease criteria of SLE - quiescent disease, defined as SLEDAI

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1. Seroconversions and fourfold titre rises after 4 weeks and after 8 weeks. 2. Geometric mean titres after four weeks and after 8 weeks	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)