Please select the arm or intervention descriptions that belong 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: Arm Label: Cervarix Group; Type: EXPERIMENTAL; Interventions: Biological: GSK Biologicals' HPV-16/18 L1 AS04 vaccine (Cervarix TM) | Arm Label: Boostrix Polio → Cervarix Group; Type: EXPERIMENTAL; Interventions: Biological: Boostrix ® Polio, Biological: GSK Biologicals' HPV-16/18 L1 AS04 vaccine (Cervarix TM) | Arm Label: Cervarix + Boostrix Polio Group; Type: EXPERIMENTAL; Interventions: Biological: Boostrix ® Polio, Biological: GSK Biologicals' HPV-16/18 L1 AS04 vaccine (Cervarix TM) | Intervention Type: BIOLOGICAL; Name: Boostrix ® Polio; Assigned to Arm(s): Boostrix Polio → Cervarix Group, Cervarix + Boostrix Polio Group | Intervention Type: BIOLOGICAL; Name: GSK Biologicals' HPV-16/18 L1 AS04 vaccine (Cervarix TM); Assigned to Arm(s): Boostrix Polio → Cervarix Group, Cervarix + Boostrix Polio Group, Cervarix Group
B: Arm Label: Cervarix Group; Type: EXPERIMENTAL; Interventions: Biological: Cervarix | Arm Label: Aluminium Hydroxide Group; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo control | Intervention Type: BIOLOGICAL; Name: Cervarix; Assigned to Arm(s): Cervarix Group | Intervention Type: BIOLOGICAL; Name: Placebo control; Assigned to Arm(s): Aluminium Hydroxide Group
C: Arm Label: Patients; Type: OTHER; Interventions: Other: Human papilloma virus vaccine (cervarix) | Intervention Type: OTHER; Name: Human papilloma virus vaccine (cervarix); Assigned to Arm(s): Patients
D: Arm Label: Gardasil®; Type: EXPERIMENTAL; Interventions: Biological: Gardasil | Arm Label: Cervarix®; Type: EXPERIMENTAL; Interventions: Biological: Cervarix | Intervention Type: BIOLOGICAL; Name: Gardasil; Assigned to Arm(s): Gardasil® | Intervention Type: BIOLOGICAL; Name: Cervarix; Assigned to Arm(s): Cervarix®

Answer: C