Please select the outcome measures that correspond to the clinical trial below.
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.


Options:
A: Number of Subjects Seroprotected Against Diphtheria and Tetanus (One month after vaccination with Boostrix Polio); Titers of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin Toxoid (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies (One month after vaccination with Boostrix Polio); Number of Subjects Seroprotected Against Poliovirus Type 1 (Polio 1), Polio 2 and Polio 3 (One month after vaccination with Boostrix Polio)
B: Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. (Up to Month 48); Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). (Up to Month 48); Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. (Up to Month 84); Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). (Up to Month 84)
C: 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)
D: Geometric mean titres of serum HPV-16 and HPV-18 antibody titers on measured by Pseudovirion-Based Neutralization Assay (PBNA) (Day 0, Day 45, Day 180, Day 210 and Day 365)

Answer: C