Multicenter randomized clinical trial in Patients with Juvenile Idiopathic Athritis: Safety and efficacy of vaccination with live attenuated Measles, Mumps, Rubella vaccine
- Conditions
- juvenile chronic arthritisjuvenile Idiopathic arthritis1000381610023213
- Registration Number
- NL-OMON38254
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 135
- all subtypes of juvenile idiopathic arthritis
- ages 4-9 (this is at least 2,5 years after initial MMR and before the scheduled booster, usually given between age 9-10)
- fifteen healthy adults (age 18-65)
- use of Infliximab (anti-TNF alpha therapy).
- primary immunodeficiency
- fever less than 48 hour prior to vaccination (here the moment of vaccination will be postponed for 1 month)
- evidence of viral or bacterial infection less than 48hours prior to vaccination (here the moment of vaccination will be postponed for 1 month)
- methylprednisolon pulse therapy less than 1 month prior to vaccination (in these cases, the moment of vaccination will be postponed for 1 month)
- transfusion of blood or bloodprocudts (e.g.) intravenous immunoglobulines (IVIG) in the 3 months prior to vaccination. (in these cases, the moment of vaccination will be postponed for 3 months);for healthy controls:
-serious adverse events to previous MMR vaccination
-Use of immunosuppressive drugs
-Primary immunodeficiency
-Fever less than 48 hour prior to vaccination (here the moment of vaccination will be postponed for 1 month)
-Evidence of viral or bacterial infection less than 48hours prior to vaccination (here the moment of vaccination will be postponed for 1 month)
-Methylprednisolon pulse therapy less than 1 month prior to vaccination (in these cases, the moment of vaccination will be postponed for 1 month)
-Pregnancy
-Lactation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome is safety of vaccination according to:<br /><br>- disease activity, measured using international validated core set criteria.<br /><br>During a 12 month follow-up period we will register disease activity<br /><br>- side-effects as overt measles, mumps or rubella infection due to vaccination.<br /><br><br /><br>The second primary outcome is efficacy of the vaccine in eliciting an<br /><br>serological response, this will be studied according to antibody levels against<br /><br>measles, mumps and rubella in the blood and presence of MMR neutralizing<br /><br>antibodies. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints are immunological changes. These are number of Tregs,<br /><br>capable to suppress proliferation in vitro; presence of anti-inflammatory<br /><br>cytokine profiles following MMR booster; number of MMR-specific T cells. Tregs<br /><br>will be isolated and their functionality will be determined using the blood<br /><br>cells collected during follow-up. the samples of five healthy controls will be<br /><br>used to construct the necessary immuno assays.</p><br>