Immunogenicity and Safety of 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

Inclusion Criteria:

- Age: 9 to 26 years of age

- Gender: Female

- All patients must fulfill the revised American College of Rheumatology Classification
Criteria for SLE diagnosis.

- Current SLEDAI score ≤ 6

- Written, witnessed informed consent and/or assent will be obtained from the subject
and the subject's parents (if under 18 years of age) or legally acceptable
representative prior to enrollment

Exclusion Criteria:

- Acute exacerbation of disease within past 30 days which required increase in
corticosteroid dose, initiation of a new immunosuppressive medication, or
hospitalization

- Current SLEDAI score > 6

- Patients who have received rituximab in the last 6 months, or are currently on
cyclophosphamide treatment

- History of allergic disease or reactions likely to be exacerbated by any component of
the study vaccine

- Previous administration of any HPV vaccine