Immune Response After Human Papillomavirus Vaccination in Patients With Autoimmune Disease

• Status: Unknown status
• Trial end date: 0000-00-00
• Target enrollment: 330
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: N.M. Wulffraat
• Collaborator: National Institute for Public Health and the Environment (RIVM)
• Treatments: Vaccines
• Last Updated: 2014-07-29

Criteria

Inclusion Criteria:

• Females

• Clinical diagnosis of JIA, SLE or JDM

• And who are in the following age groups:

• 12 years (these girls are vaccinated via the National Vaccination Program from September 2009)

• 13-18 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)

Exclusion Criteria:

• No HPV vaccination

• Refusal to allow venous puncture

• Proven or suspected cervical carcinoma