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Immunogenicity and Safety of HPV Vaccine Gardasil in Young Women

This study has been completed.
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of Chicago Identifier:
First received: November 5, 2008
Last updated: September 4, 2013
Last verified: December 2012

November 5, 2008
September 4, 2013
November 2008
August 2010   (Final data collection date for primary outcome measure)
Primary outcome measures are Mean Geometric HPV Antibody Titers and a change in SLE disease activity [ Time Frame: 7 months ]
Same as current
Complete list of historical versions of study NCT00786409 on Archive Site
Secondary outcome measure is induction or increase of autoantibodies [ Time Frame: 7 months ]
Same as current
Not Provided
Not Provided
Immunogenicity and Safety of HPV Vaccine Gardasil in Young Women
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

Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Systemic Lupus Erythematosus
Biological: Gardasil
0.5 ml Gardasil vaccine will be administered to each patient at months 0,2 and 6.
30 patients will receive 0.5 ml Gardasil vaccine at months 0,2, and 6.
Intervention: Biological: Gardasil
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2011
August 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
9 Years to 26 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
United States
MERCK: MISP for Gardasil#33598
Not Provided
Not Provided
Not Provided
University of Chicago
University of Chicago
Merck Sharp & Dohme Corp.
Principal Investigator: Linda Wagner-Weiner, MD University of Chicago
University of Chicago
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP