Influenza, pneumococcal and hepatitis B vaccination in patients with rheumatic autoimmune diseases treated with immunosuppressive therapy

Completed

Conditions: 10003816
Rheumatic autoimmune diseases
Rheuma.

Registration Number: NL-OMON32031

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

All patients and healthy controls must be:
1. 35-75 years of age
2. BMI >= 18.5
3. Willing to give written informed consent
4. Diagnosed with rheumatoid arthritis according to the 1987-revised ACR-classification criteria or poly or dermatomyositis according to the criteria of Bohan and Peter.

Exclusion Criteria

Patients and controls are excluded from the study if he/she meets any of the following criteria:
1. Pregnancy
2. History of vaccination allergy
3. Known allergy to egg products
4. Positive hepatitis B serologyor denial to be tested or informed over the hepatitis B serology results
5. Rheumatic autoimmune disorder other than rheumatoid arthritis or poly or dermatomyositis

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoints are the humoral responses to influenza, pneumococcal<br /><br>and hepatitis B vaccination. The humoral responses will be analysed using the<br /><br>response rates and the geometric mean titres (GMT).<br /><br>For influenza, seroprotection rates are defined as a serum HI titre >=1/40.<br /><br>Seroconversion rates are defined as a 4 fold rise in serum HI titre or serum HI<br /><br>titre changing from <1/40 to >=40.<br /><br>The humoral response to pneumococcal vaccination is defined according to the<br /><br>WHO as a >= 2 fold increase in antibody titers and a postvaccinationtiter of >=<br /><br>0.35 ug/ml.<br /><br>Response to hepatitis B vaccination is defined as an antibody titre higher than<br /><br>10 IU/l after vaccination. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The safety of influenza, pneumococcal and hepatitis B vaccination will be<br /><br>assessed by reporting adverse events on an adverse events registration form.<br /><br>The effects of influenza, pneumococcal and hepatitis B vaccination on disease<br /><br>activity of the rheumatic autoimmune diseases will be assessed by the DAS28<br /><br>score. The Health Assessment Questionnaire (HAQ) will be taken to assess<br /><br>disability.</p><br>