Immune Response After Human Papillomavirus Vaccination in Patients With Autoimmune Disease

NCT00815282 | Completed Phase 4

• 2 other identifiers: NL26.113.000.08EUDRACT number 2008-008169-36
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 3

Brief Summary

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 system disorder, such as primary humoral immunodeficiency (i.e. hypogammaglobulinemia) 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 immune system 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 investigators 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.

Conditions

Juvenile Idiopathic Arthritis; Systemic Lupus Erythematosus; Juvenile Dermatomyositis

Outcome Measures

Primary Outcomes (1)

• the immunogenicity of HPV vaccination in patients with immune system disorders. The immunogenicity of HPV vaccination in patients will be compared to healthy controls, measured by antibody levels against HPV serotype 16 & 18.

  0, 3, 7, 12 months

Secondary Outcomes (1)

• difference in the activity of underlying disease before versus after vaccination. A difference in the activity of underlying autoimmune disease, will be measured according to specific criteria for each autoimmune disease.

  0,3,7,12 months

Study Arms (1)

Patients

OTHER

patients were girls aged 15 to 18 immunised with the HPV vaccine according to dutch vaccination guidelines

Other: Human papilloma virus vaccine (cervarix)

Interventions

Human papilloma virus vaccine (cervarix) OTHER

vaccination at 0, 1 and 6 months

Also known as: Cervarix vaccine (GlaxoSmithKLine)

Patients

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Females
• Clinical diagnosis of JIA, SLE or JDM
• And who are in the following age groups:
• years (these girls are vaccinated via the National Vaccination Program from September 2009)
• years (these girls are vaccinated during a national vaccination campaign from March-May 2009)
• Current co-medication: all co-medication prescribed may be continued
• And in the control group: healthy girls aged 13-17 years (these girls are vaccinated during a national vaccination campaign from March-May 2009)

You may not qualify if:

• No HPV vaccination
• Refusal to allow venous puncture
• Proven or suspected cervical carcinoma

Sponsors & Collaborators

• N.M. Wulffraat: lead
• National Institute for Public Health and the Environment (RIVM): collaborator

Study Sites (3)

University Medical center Groningen

Groningen, 9700RB, Netherlands

Location

Erasmus Medical Center Rotterdam

Rotterdam, 3000CB, Netherlands

Location

UMC Utrecht, department of pediatrics

Utrecht, 3508AB, Netherlands

Location

Related Publications (3)

• Heijstek MW, Pileggi GC, Zonneveld-Huijssoon E, Armbrust W, Hoppenreijs EP, Uiterwaal CS, Kuis W, Wulffraat NM. Safety of measles, mumps and rubella vaccination in juvenile idiopathic arthritis. Ann Rheum Dis. 2007 Oct;66(10):1384-7. doi: 10.1136/ard.2006.063586. Epub 2007 Feb 6.

  PMID: 17284544 RESULT

• Zonneveld-Huijssoon E, Ronaghy A, Van Rossum MA, Rijkers GT, van der Klis FR, Sanders EA, Vermeer-De Bondt PE, Hoes AW, van der Net JJ, Engels C, Kuis W, Prakken BJ, Van Tol MJ, Wulffraat NM. Safety and efficacy of meningococcal c vaccination in juvenile idiopathic arthritis. Arthritis Rheum. 2007 Feb;56(2):639-46. doi: 10.1002/art.22399.

  PMID: 17265499 RESULT

• Heijstek MW, Scherpenisse M, Groot N, Tacke C, Schepp RM, Buisman AM, Berbers GA, van der Klis FR, Wulffraat NM. Immunogenicity and safety of the bivalent HPV vaccine in female patients with juvenile idiopathic arthritis: a prospective controlled observational cohort study. Ann Rheum Dis. 2014 Aug;73(8):1500-7. doi: 10.1136/annrheumdis-2013-203429. Epub 2013 May 30.

  PMID: 23723319 RESULT

MeSH Terms

Conditions

Arthritis, Juvenile; Lupus Erythematosus, Systemic; Dermatomyositis

Interventions

Papillomavirus Vaccines; human papillomavirus vaccine, L1 type 16, 18; halofantrine

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Polymyositis; Myositis; Muscular Diseases; Neuromuscular Diseases; Nervous System Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Nico M Wulffraat, MD, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 24, 2008
• First Posted: December 29, 2008
• Study Start: February 1, 2009
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: November 13, 2017

Record last verified: 2017-11

Locations

NL (3)