|Sponsor:||University of Chicago|
|Information provided by:||University of Chicago|
The purpose of this study is to evaluate the immunogenicity and safety of the HPV vaccine Gardasil in young women.
|Study Design:||Control: Historical Control
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Immunogenicity and Safety of the Quadrivalent HPV Vaccine Gardasil in Female Systemic Lupus Erythematosus Patients Aged 9-26|
Primary Outcome Measures:
- Primary outcome measures are Mean Geometric HPV Antibody Titers and a change in SLE disease activity [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Secondary outcome measure is induction or increase of autoantibodies [ Time Frame: 7 months ] [ Designated as safety issue: No ]
|Study Start Date:||November 2008|
|Estimated Study Completion Date:||November 2009|
|Estimated Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)
Female patients with systemic lupus erythematosus (SLE) have been found have higher rates of persistent HPV infections and precancerous lesions compared to the healthy population. The HPV vaccine Gardasil has been found to be safe and efficacious in females aged 9 to 26 years. There are no data on the immunogenicity and safety of Gardasil in females with SLE. Immune dysfunction related to SLE itself and the immunosuppression secondary to treatment of SLE might prevent patients with SLE from developing an adequate immune response to the vaccine. Also, theoretically, the vaccine might induce a disease exacerbation or production of new autoantibodies.
The purpose of this study is to evaluate immunogenicity and safety of Gardasil and its effects on autoantibody profile in female SLE patients aged 9-26 years.
a) Too little too late?
b) The cart before – the horse?
c) Pressure from the public?
The answer is “c.” Women with autoimmune diseases were not tested for adverse reactions to the HPV vaccines.