Contact information
Type
Scientific
Primary contact
Ms M.W. Heijstek
ORCID ID
Contact details
University Medical Centre Utrecht
Wilhelmina Children's Hospital
Utrecht
3584 EA
Netherlands
+31 (0)88 75 549 68
M.W.Heijstek@umcutrecht.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00731965
Protocol/serial number
N/A
Study information
Scientific title
Acronym
VAART
Study hypothesis
The primary objective of the study is to study the safety of Measles, Mumps, Rubella (MMR) booster vaccination in Juvenile Idiopathic Arthritis (JIA) patients by measuring JIA disease activity and the occurrence of measles, mumps or rubella infection.
The next primary objective is to evaluate the efficacy of the MMR booster vaccination in JIA patients by measuring protective immunity responses (specific anti measles, rubella, mumps antibodies by Enzyme-Linked Immunosorbent Assay [ELISA]) and functional antibody assays (measles neutralising antibodies) before and after MMR vaccination.
The secondary aim of the vaccination study is to analyse the influence on immune regulatory mechanisms capable of inducing JIA disease remission.
Ethics approval
Ethics approval received from the Centrale Commissie Mensgebonden Onderzoek (CCMO) and the Medical Ethics Committee of the participating centres for local feasibility on the 7th February 2008 (ref: NL 17376.000.07).
Study design
Multi-centre prospective randomised controlled open-label vaccination study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Juvenile Idiopathic Arthritis (JIA)
Intervention
Please note that as of 29/04/08 the anticipated start and end dates of this trial were updated to the above. The previous start and end dates were:
Previous anticipated start date: 01/12/2007
Previous anticipated end date: 01/12/2010
Included patients will be randomised for one extra MMR booster vaccination (at age 4 to 8) or no additional vaccination (controls). Placebo vaccines will not be used in the control group.
N.B. In the Netherlands all children receive MMR booster vaccination at 9 years of age. Patients in both groups will also receive their usual MMR booster vaccine at age 9 according to the National Vaccination Program.
Intervention type
Drug
Phase
Not Specified
Drug names
Measles, Mumps, Rubella vaccine
Primary outcome measure
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), measured at baseline, and 3, 6 and 12 months after vaccination
2. Efficacy of MMR booster, defined by specific antibodies against measles, mumps and rubella, measured at baseline and 3 and 12 months after vaccination
Secondary outcome measures
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
These are measured at baseline and three months after vaccination.
Overall trial start date
15/05/2008
Overall trial end date
15/05/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. All subtypes of JIA according to International League of Associations for Rheumatology (ILAR) criteria
2. Ages 4 to 8
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
280
Participant exclusion criteria
1. Use of Infliximab (Remicade, anti-Tumour Necrotising Factor [anti-TNF] alpha therapy)
2. Participation in another (drug) trial
3. Primary immunodeficiency
4. Fever less than 48 hour prior to vaccination (here the moment of vaccination will be postponed for one month)
5. Evidence of viral or bacterial infection less than 48 hours prior to vaccination (here the moment of vaccination will be postponed for one month)
6. Methylprednisolone pulse therapy less than one month prior to vaccination (in these cases, the moment of vaccination will be postponed for one month)
Please note that, as of 11/09/2008, the following exclusion criterion has been removed:
Use of Anakinra (Kineret, human interleukine-1-receptor antagonist)
Recruitment start date
15/05/2008
Recruitment end date
15/05/2011
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Centre Utrecht
Utrecht
3584 EA
Netherlands
Sponsor information
Organisation
University Medical Centre Utrecht (UMCU) (Netherlands)
Sponsor details
Wilhelmina Children's Hospital (WKZ)
P.O. Box 85090
KC.03.063.0
Utrecht
3508 AB
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
University Medical Centre Utrecht (UMCU) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list