Immune Response After Human Papillomavirus Vaccination in Patients With Autoimmune Disease
Status:
Unknown status
Trial end date:
0000-00-00
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
N.M. Wulffraat
Collaborator:
National Institute for Public Health and the Environment (RIVM)