VAccination in ARThritis (VAART-onderzoek) - multicentre randomised clinical trial in patients with juvenile idiopathic arthritis: safety and efficacy of vaccination with live attenuated Measles, Mumps, Rubella vaccine

ISRCTN	ISRCTN12271664
DOI	https://doi.org/10.1186/ISRCTN12271664
ClinicalTrials.gov (NCT)	NCT00731965
Protocol serial number	N/A
Sponsor	University Medical Centre Utrecht (UMCU) (Netherlands)
Funder	University Medical Centre Utrecht (UMCU) (Netherlands)

Submission date: 23/08/2007
Registration date: 23/08/2007
Last edited: 14/02/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms M.W. Heijstek
Scientific

University Medical Centre Utrecht
Wilhelmina Children's Hospital
Utrecht
3584 EA
Netherlands

Phone	+31 (0)88 75 549 68
Email	M.W.Heijstek@umcutrecht.nl

Study information

Primary study design	Interventional
Study design	Multi-centre prospective randomised controlled open-label vaccination study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	VAccination in ARThritis (VAART-onderzoek) - multicentre randomised clinical trial in patients with juvenile idiopathic arthritis: safety and efficacy of vaccination with live attenuated Measles, Mumps, Rubella vaccine
Study acronym	VAART
Study objectives	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(s)	Centrale Commissie Mensgebonden Onderzoek (CCMO) and the Medical Ethics Committee of the participating centres for local feasibility, 07/02/2008, ref: NL 17376.000.07
Health condition(s) or problem(s) studied	Juvenile Idiopathic Arthritis (JIA)
Intervention	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	Biological/Vaccine
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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.
Completion date	15/05/2011

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	4 Years
Upper age limit	8 Years
Sex	All
Target sample size at registration	280
Key inclusion criteria	1. All subtypes of JIA according to International League of Associations for Rheumatology (ILAR) criteria 2. Ages 4 to 8
Key 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)
Date of first enrolment	15/05/2008
Date of final enrolment	15/05/2011

Locations

Countries of recruitment

Netherlands

Study participating centre

University Medical Centre Utrecht

Utrecht
3584 EA
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	19/06/2013	14/02/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

14/02/2019: Publication reference added.
29/04/2008: The overall trial start and end dates of this trial were updated. The previous start and end dates were:
Previous overall trial start date: 01/12/2007
Previous overall trial end date: 01/12/2010