Status:
COMPLETED
Immunogenicity and Safety of HPV Vaccine Gardasil in Young Women
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Systemic Lupus Erythematosus
Eligibility:
FEMALE
9-26 years
Phase:
NA
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 Gard...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00786409
Start Date
November 1 2008
End Date
December 1 2011
Last Update
February 15 2018
Active Locations (1)
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1
University of Chicago
Chicago, Illinois, United States, 60637