Immunogenicity and Safety of HPV Vaccine Gardasil in Young Women
Information source: University of Chicago
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Systemic Lupus Erythematosus
Intervention: Gardasil (Biological)
Phase: N/A
Status: Not yet recruiting
Sponsored by: University of Chicago Official(s) and/or principal investigator(s):
Linda Wagner-Weiner, MD, Principal Investigator, Affiliation: University of Chicago
Overall contact:
Arzu Soybilgic, MD, Phone: 773-834-1952, Email: arzu@uchicago.edu
Summary
The purpose of this study is to evaluate the immunogenicity and safety of the HPV vaccine
Gardasil in young women.
Clinical Details
Official title: Immunogenicity and Safety of the Quadrivalent HPV Vaccine Gardasil in Female Systemic Lupus Erythematosus Patients Aged 9-26
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Primary outcome measures are Mean Geometric HPV Antibody Titers and a change in SLE disease activity
Secondary outcome: Secondary outcome measure is induction or increase of autoantibodies
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
Eligibility
Minimum age: 9 Years.
Maximum age: 26 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Arzu Soybilgic, MD, Phone: 773-834-1952, Email: arzu@uchicago.edu
University of Chicago, Chicago, Illinois 60637, United States
Additional Information
Related publications: Nath R, Mant C, Luxton J, Hughes G, Raju KS, Shepherd P, Cason J. High risk of human papillomavirus type 16 infections and of development of cervical squamous intraepithelial lesions in systemic lupus erythematosus patients. Arthritis Rheum. 2007 May 15;57(4):619-25.
Starting date: November 2008
Last updated: November 5, 2008
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