Clinical Trial: Immune Response After Human Papillomavirus Vaccination in Patients With Autoimmune Disease

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Immune Response After Human Papillomavirus Vaccination in Patients With Autoimmune Disease

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.


Detailed Summary:

Study design: prospective observational cohort study.

Study population: Females aged 12 - 18 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 control group 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 immune system disorder. The vaccines are administered by our national health organisation. The effects are monitored in our clinics.

Main study parameters/endpoints:

  • Primary outcome immunogenicity is measured by antibody levels against HPV serotype 16 & 18 over time. We consider HPV vaccination to be immunogenic at antibody titers above the cutoffs 20 and 24 mMU/ml for HPV 16 and 18, respectively; or at a ≥2 fold increase in antibody levels against both serotypes. The antibody levels will be measured prior to vaccination, and after 3,7 and 12 months.
  • The secondary outcome is safety of vaccination, measured as activity of the underlying autoimmune disease. In addition, frequency of common adverse effects, and immunological changes induced by HPV vaccination, su
    Sponsor: N.M. Wulffraat

    Current Primary Outcome: 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. [ Time Frame: 0, 3, 7, 12 months ]

    Original Primary Outcome: the immunogenicity of HPV vaccination in patients with immunesystem disorders. The immunogenicity of HPV vaccination in patients will be compared to healthy controls, measured by antibody levels against HPV serotype 16 & 18. [ Time Frame: 0, 3, 7, 12 months ]

    Current Secondary Outcome: 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. [ Time Frame: 0,3,7,12 months ]

    Original Secondary Outcome: Same as current

    Information By: UMC Utrecht

    Dates:
    Date Received: December 24, 2008
    Date Started: February 2009
    Date Completion: December 2016
    Last Updated: July 29, 2014
    Last Verified: July 2014