Safety and Efficacy of Measles, Mumps, Rubella Vaccination in Juvenile Idiopathic Arthritis (VAART)
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|ClinicalTrials.gov Identifier: NCT00731965|
Recruitment Status : Completed
First Posted : August 11, 2008
Last Update Posted : July 30, 2014
The safety of vaccination in patients with autoimmune diseases using immune suppressive therapy is often discussed. Previous studies in Juvenile Idiopathic Arthritis (JIA) patients showed no increase in disease activity after immunisation with dead vaccines. The safety of the live attenuated Measles, Mumps, Rubella (MMR) vaccination was assessed retrospectively in JIA patients and no increase in disease activity was found. However, this must be prospectively confirmed. In addition, it is unknown whether vaccination is effective, since the immune response to vaccination may be diminished due to immunosuppressive therapy for the underlying disease. Finally, the influence of MMR vaccination on the immune system of JIA patients has not been studied. Among others, regulatory T-cells (Tregs) should control the immune response and prevent destructive autoimmune responses after environmental triggers such as vaccination.
The aim of the present study is to investigate the safety and efficacy of the MMR booster vaccination and its influence on immune regulatory mechanisms in children with Juvenile Idiopathic Arthritis.
JIA patients aged 4 to 8 years and treated by the pediatric rheumatology units from various University Medical Centers in the Netherlands, are asked to participate in a prospective study. In the Netherlands, measles-mumps-rubella (MMR) vaccination is included in the National Vaccination Program and is normally administered at age 9. Included patients will be randomised for early vaccination (age group 4 to 8yr at entry of the study) or at age 9 as is routinely done according to the National Vaccination Program. Prior to and after vaccination the investigators will assess disease activity and collect blood.
During a 12 month follow-up period the investigators will register disease activity and side-effects at different moments in time to determine safety of vaccination. The efficacy of the vaccine will be studied according to antibody levels and function against measles, mumps and rubella in the blood. Tregs will be isolated and their functionality will be determined using the blood cells collected during follow-up. This enables us to study the role influence of vaccination on regulatory mechanisms in our immune system.
|Condition or disease||Intervention/treatment||Phase|
|Arthritis, Juvenile Rheumatoid||Biological: Measles, Mumps, Rubella vaccination||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter Randomized Clinical Trial in Patients With Juvenile Idiopathic Arthritis: Safety and Efficacy of Vaccination With Live Attenuated Measles, Mumps, Rubella Vaccine|
|Study Start Date :||May 2008|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
Measles, mumps, rubella booster vaccination within 3 months after randomisation
Biological: Measles, Mumps, Rubella vaccination
Dosage: 1 dose MMR vaccine, containing 5000 p.f.u. (plaque forming unit) life attenuated mumps virus (Jeryl-Lynn-strain), 1000 p.f.u. life attenuated measles virus (Moraten-strain) and 1000 p.f.u. life attenuated rubella virus (Wistar RA 27/3-strain) + 0.5 ml solution fluid Dosage form: subcutaneously frequency: once
Other Name: RVG 17654, BMR-NVI
No Intervention: 2
Booster vaccination performed by regular health authorities at age 9; at least 1 year after randomisation
- JIA disease activity, defined by the core set criteria for JIA and number of flares [ Time Frame: baseline and after 3, 6,9,12 months ]
- Immunological reaction to MMR vaccination and regulatory mechanisms induced by MMR, measured by number and function of MMR-specific T cells and cytokine profiles [ Time Frame: baseline, 3 and 12 months ]immunogenicity measuring antibody titers and T cell profileration to rubella virus
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00731965
|Academic hospital Maastricht|
|Maastricht, Limburg, Netherlands, 6202 AZ|
|VU University Medical Center Amsterdam|
|Amsterdam, Netherlands, 1007 MB|
|University Medical Center Groningen, Beatrix Children's Hospital|
|Groningen, Netherlands, 9700 RB|
|Erasmus Medical Center Rotterdam; sophia Children's Hospital|
|Rotterdam, Netherlands, 3000 CB|
|University Medical Center Utrecht, Wilhelmina Children's Hospital|
|Utrecht, Netherlands, 3508 AB|
|Principal Investigator:||Nico M. Wulffraat, MD;PhD||UMC Utrecht|