Systemic Lupus Erythematosus Clinical Trial
Official title:
Immunogenicity and Safety of the Quadrivalent HPV Vaccine Gardasil in Female Systemic Lupus Erythematosus Patients Aged 9-26
The purpose of this study is to evaluate the immunogenicity and safety of the HPV vaccine Gardasil in young women.
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
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