Rheumatic autoimmune diseases including rheumatoid arthritis and poly or dermatomyositis.
Conditions
Interventions
Trade Name: Influvac
Pharmaceutical Form:
INN or Proposed INN: Influvac
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 0,5-
Trade Name: Pneumovax 23
Pharmaceuti
Sponsors
Radboud University Nijmegen Medical Centre
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the humoral response to influenza, pneumococcal and hepatitis B vaccination in patients with rheumatic autoimmune diseases (reumathoid arthritis and poly- dermato-myositis) treated with immunosuppressive therapy. ;Secondary Objective: The secondary objectives are to evaluate the safety of these vaccinations and to evaluate the humoral response to a two-dose vaccination regimen of influenza vaccination in patients with rheumatic autoimmune diseases (reumathoid arthritis and poly- dermato-myositis) treated with immunosuppressive therapy. ;Primary end point(s): The main study endpoints are the humoral responses to influenza, pneumococcal and hepatitis B vaccination in patients with RA poly- and dermatomyositis. The humoral response to influenza vaccination will be analysed by the haemagglutination-inhibition (HI) test, according to standard procedures. Response to influenza vaccination is defined by the seroprotection rate (the percentage of patients with serum HI titres of > = 1/40 after vaccination) and the seroconversion rate (the percentage of patients with a 4 fold raise of serum HI titres after vaccination, if HI antibodies at baseline are > =1/40, or the percentage of patients with a non-protective baseline level of antibodies of =1/40 after vaccination). The humoral response to pneumococcal vaccination will be analysed using the WHO recommendations, as the percentage with a postvaccination antibody titer = 0.35 ug/ml in combination with at least a twofold increase in antibody titer 4. Response to the hepatitis B vaccination, is defined as an antibody titre higher than 10 IU/l after vaccination. | — |
Countries
Netherlands
Outcome results
None listed