Immune response after Human Papillomavirus vaccination in patients with automimmune disease

Phase 4

Completed

Conditions: JDM
Juvenile Idiopathic Arthritis
SLE
10038594
10003816
10046828

Registration Number: NL-OMON40068

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 140

Inclusion Criteria

Females Who have one of the following immunsystem disorder:
a. Juvenile Idiopathic Arthritis
b. Systemic Lupus Erythematosus
c. Juvenile Dermatomyositis
Current co-medication: all co-medication such as Methotrexate, etanercept, anakinra or infliximab may be continued.
And who are in the following age groups:
a. 12 years (these girls are vaccinated via the National Vaccination Program from September 2009)
b. 13-17 years (these girls are vaccinated during a national vaccination campaign from March-May 2009)

Exclusion Criteria

- Refusal to be vaccinated with the HPV vaccine
- Allergic reactions to one of the components of the vaccine.
- Acute, severe disease accompanied with fever. In this case, the moment of vaccination will be postponed for 1 month. A light infection, such as an upper airway infection, is not a reason to postpone the vaccination.
-Proven or suspected cervix carcinoma
-failure to comply

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome immunogenicity is defined as the serological immune response<br /><br>measured by antibody levels against HPV serotype 16 & 18. The antibody levels<br /><br>will be measured prior to vaccination, and after 3, 7 and 12 months. Antibody<br /><br>titers over time above the cutoffs 20 and 24 mMU/ml for HPV 16 and 18 or a >=2<br /><br>fold increase in antibody titers against both serotypes are seen as a positive<br /><br>response and will be analyzed in patients and healthy controls.. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcome is safety of vaccination, measured as activity of the<br /><br>underlying disease. Other secondary outcomes are frequency of common adverse<br /><br>effects, and immunological changes induced by HPV vaccination, such as number<br /><br>and function of cytotoxic T cells and Tregs.</p><br>