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Sponsors and Collaborators: |
UMC Utrecht National Institute for Public Health and the Environment (RIVM) |
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Information provided by: | UMC Utrecht |
ClinicalTrials.gov Identifier: | NCT00815282 |
In the Netherlands, the human Papillomavirus (HPV) vaccination will be added to the National Vaccination Program for girls to protect against the development of cervical cancer. The vaccine protects against HPV type 16 & 18, which cause about 75% of cervical cancer. Studies have shown that the vaccine is effective in healthy subjects in preventing infection by HPV 16 & 18. However, no evidence exists on the immunogenicity and safety of HPV vaccination in patients with an immune sytem disorder, such as primary humoral immunodeficiency (i.e. hypogammaglobulineamia) or autoimmune diseases. Concerns exist that vaccination may cause an aggravation of the underlying disease. In addition, the immune response to vaccination may be diminished due to immunosuppressive therapy or the underlying disease.
Objective: The primary goal of the current study is to study the immunogenicity of HPV vaccination in patients with an autoimmune disease and a primary humoral immunodeficiency.
Based on retrospective analysis with other vaccines we hypothesize that patients with autoimmune diseases who are under immunosuppressive medication and patients with a immunesystem disorder have a decreased serological response to HPV vaccination, and that the produced HPV antibodies titers decrease more rapidly than in healthy individuals.
The secondary objective is to explore safety of HPV vaccination and immune regulatory mechanisms induced by vaccination in a subset of patients. The investigotors hypothesize that HPV vaccination is safe and that HPV-induced regulatory T cells are able to prevent an increase in the activity of an autoimmune disease.
Condition | Intervention |
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Juvenile Idiopathic Artrhritis Systemic Lupus Erythematosus Juvenile Dermatomyositis |
Drug: Human papilloma virus vaccine (cervarix) |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Immune Response After Human Papillomavirus Vaccination in Patients With Autoimmune Disease |
serum and lymphocytes
Estimated Enrollment: | 333 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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JIA, SLE, JDM
females with auto-immune diseases (juvenile idiopathic artritis, SLE, Juvenile Dermatomyositis
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Drug: Human papilloma virus vaccine (cervarix)
vaccination at 0, 1 and 6 months
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Healthy females
Age matched controls 12-17 yr.
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Drug: Human papilloma virus vaccine (cervarix)
vaccination at 0, 1 and 6 months
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Study design: prospective observational cohort study.
Study population: Females aged 12 - 17 years with one of the autoimmune diseases Juvenile Idiopathic Arthritis (JIA), Systemic Lupus Erythematosus (SLE) and Juvenile Dermatomyositis (JDM) are included. Included females are treated at the rheumatology unit from the University Medical Center Utrecht. A small controlgroup of healthy girls aged 13 -17 years will also be included to compare the kinetics of HPV serology with healthy individuals.
Intervention: Starting from September 2009 all girls aged 12 years will be offered a HPV vaccination via the National Vaccination Program. Prior to this, a national campaign will be started in March 2009 to vaccinate all girls aged 13-17 years at once..We will use this national vaccination campaign as an opportunity to analyze the serological response and safety of this vaccine in a large group of with an immunesystem disorder.
Main study parameters/endpoints:
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Burden: included patients will be asked to visit the hospital 4 times in a period of 12 months. During these visits, physical examination will be performed and blood will be obtained for serological and immunological analysis. Most of these visits are combined with routine follow-up and venous punctures of the patients. However, one extra visit to the hospital and vena puncture is expected. 5 ml (extra) blood is obtained four times from all patients for serological analysis. Included healthy controls will be asked to visit one plenary information meeting in the evening. Controls will have a venous punctures four times during the study, during which 5 ml of blood is obtained. These samples will be obtained at the hospital during evening clinics or at school. In a subset of patients (n=50) and healthy controls (n=10), an additional 15 ml is obtained for immunological analysis.
Risks: participants may experience adverse events of the HPV vaccination. Benefits: Protection against human Papillomavirusinfection and therefore reduced risk of cervix carcinoma, certainty about protection against HPV 16 & 18 and about safety of HPV vaccination.
Group relatedness: This study can only be done in patients who need this vaccination (i.e. females in the age group 12-24 years) and have an immunesystem disorder, such as JIA, SLE or JDM. Appropriate comparison with healthy controls must be performed in age-matched healthy females who are also recruited for the National HPV vaccination campaign, in this case girls in the age group 13-17 years.
Ages Eligible for Study: | 12 Years to 17 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
tertiary university referral center for children with rheumatological disorders. The healthy controls will be selected from local secondary schools.
Inclusion Criteria:
And who are in the following age groups:
Exclusion Criteria:
Contact: Nico M Wulffraat, MD | (31)887554003 | n.wulffraat@umcutrecht.nl |
Contact: Marloes W Heijstek, MD | (31)887554003 | m.w.heijstek@umctrecht.nl |
Netherlands | |
UMC Utrecht, department of peiatrics | |
Utrecht, Netherlands, 3508AB |
Principal Investigator: | Nico M Wulffraat, MD, PhD | University medical Center Utrecht |
Study Director: | Fiona van der KLis, MD, PhD | National Institute for public health and the environment |
Study Director: | Guy Berbers, PhD | National Institute for public health and the environment |
Responsible Party: | University Medical Center Utrecht, department of pediatrics ( NM Wulffraat, MD, PhD ) |
Study ID Numbers: | NL26.113.000.08, EUDRACT number 2008-008169-36 |
Study First Received: | December 24, 2008 |
Last Updated: | December 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00815282 |
Health Authority: | Netherlands: Ministry of Health, Welfare and Sport; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Myositis Juvenile dermatomyositis Dermatomyositis Muscular Diseases Autoimmune Diseases Skin Diseases |
Neuromuscular Diseases Musculoskeletal Diseases Lupus Erythematosus, Systemic Connective Tissue Diseases Polymyositis Idiopathic myopathy |
Immune System Diseases Nervous System Diseases |