VAART-onderzoek (VAccination in ARTritis).

Multicenter randomized clinical trial in Patients with Juvenile Idiopathic Athritis: Safety and efficacy of vaccination with live attenuated Measles, Mumps, Rubella vaccine

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26319

Enrollment

280

Registered

2007-07-03

Start date

2007-08-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Juvenile Idiopathic Arthritis (JIA) Measles, Mumps, Rubella Vaccination

Interventions

Included patients will be randomized for one extra MMR booster vaccination (at age 4-8) or no additional vaccination (controls). Placebo vaccines will not be used in the control group. N.B. In the N

Eligibility

Inclusion criteria

Inclusion criteria: 1. All subtypes of JIA according to ILAR criteria; 2. Ages 4 to 8

Exclusion criteria

Exclusion criteria: 1. Use of Infliximab (Remicade, anti-TNF alpha therapy). 2. Use of Anakinra (Kineret, human interleukine-1-receptorantagonist) 3. Participation in another (drug) trial 4. Primary immunodeficiency 5. Fever less than 48 hour prior to vaccination (here the moment of vaccination will be postponed for 1 month) 6. Evidence of viral or bacterial infection less than 48hours prior to vaccination (here the moment of vaccination will be postponed for 1 month) 7. Methylprednisolon pulse therapy less than 1 month prior to vaccination (in these cases, the moment of vaccination will be postponed for 1 month)

Design outcomes

Primary

Measure	Time frame
Safety of MMR vaccination, according to: 1. JIA disease activity (defined by internationally validated core set criteria, number of disease flares in the 12 months after MMR vaccination and medication use) Measles, mumps or rubella infections 2. Efficacy of MMR booster, defined by specific antibodies against measles, mumps and rubella.	—

Secondary

Measure	Time frame
Secondary outcome measures are: 1. Number of Tregs, that are capable to suppress proliferation in vitro. 2. Presence of anti-inflammatory cytokine profiles following MMR booster 3. Number and function of MMR-specific T cells	—

Contacts

Public ContactM.W. Heijstek

Universitary Medical Center Utrecht, Wilhelmina Children's Hospital

M.W.Heijstek@umcutrecht.nl+31(0)30 2504968

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)