Immunogenicity and Safety of HPV Vaccine Gardasil in Young Women

Not Applicable

Completed

Brief Summary: The purpose of this study is to evaluate the immunogenicity and safety of the HPV vaccine Gardasil in young women.

Detailed Description: 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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Gardasil	Gardasil	30 patients will receive 0.5 ml Gardasil vaccine at months 0,2, and 6.

Primary Outcome Measures

Name	Time	Method
Anti-HPV 6 Seroconversion	7 months	Percent Seropositive
Anti-HPV 16 Seroconversion	7 months	% Seropositive
Anti-HPV 18 Seroconversion	7 months	% Seropositive
Anti-HPV 11 Seroconversion	7 months	% Seropositive
Anti-HPV 6 GMT	7 months	Geometric mean titre in milli-Merck units per ml (mMu/ml)
Anti-HPV 18 GMT	7 months	Geometric mean titre in milli-Merck units per ml (mMu/ml)
Anti-HPV 11 GMT	7 months	Geometric mean titre in milli-Merck units per ml (mMu/ml)
Anti-HPV 16 GMT	7 months	Geometric mean titre in milli-Merck units per ml (mMu/ml)
SLEDAI Change Score	7 months	Systemic Lupus Erythematosus Disease Activity Index (SLEDAI): change from baseline to 7 months. The SLEDAI scale is a weighted sum of 16 clinical and 8 laboratory items. Scores range from 0 to 105 with higher scores indicating worse outcome. The variable analyzed here is the 7 month score minus the baseline score. Therefore negative values indicate an improvement in outcome.

Secondary Outcome Measures

Name	Time	Method
Induction or Increase of Autoantibodies (Conversion From Negative Anti-RNP to Positive Anti-RNP) Anti-RNP	7 months
Induction or Increase of Autoantibodies (Conversion From Negative Smith to Positive Smith)	7 months
Induction or Increase of Autoantibodies (Conversion From Lupus Anticoagulant Negative to Lupus Anticoagulant Positive)	7 months