Immunogenicity and Safety of HPV Vaccine Gardasil in Young Women
|Study Design:||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 are Mean Geometric HPV Antibody Titers and a change in SLE disease activity [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
- Secondary outcome measure is induction or increase of autoantibodies [ Time Frame: 7 months ] [ Designated as safety issue: No ]
|Study Start Date:||November 2008|
|Study Completion Date:||December 2011|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
30 patients will receive 0.5 ml Gardasil vaccine at months 0,2, and 6.
0.5 ml Gardasil vaccine will be administered to each patient at months 0,2 and 6.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00786409
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Linda Wagner-Weiner, MD||University of Chicago|