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Immunogenicity and Safety of HPV Vaccine Gardasil in Young Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00786409
Recruitment Status : Completed
First Posted : November 6, 2008
Last Update Posted : September 5, 2013
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Systemic Lupus Erythematosus Biological: Gardasil

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of the Quadrivalent HPV Vaccine Gardasil in Female Systemic Lupus Erythematosus Patients Aged 9-26
Study Start Date : November 2008
Primary Completion Date : August 2010
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
30 patients will receive 0.5 ml Gardasil vaccine at months 0,2, and 6.
Biological: Gardasil
0.5 ml Gardasil vaccine will be administered to each patient at months 0,2 and 6.

Outcome Measures

Primary Outcome Measures :
  1. Primary outcome measures are Mean Geometric HPV Antibody Titers and a change in SLE disease activity [ Time Frame: 7 months ]

Secondary Outcome Measures :
  1. Secondary outcome measure is induction or increase of autoantibodies [ Time Frame: 7 months ]

Eligibility Criteria

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Ages Eligible for Study:   9 Years to 26 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00786409

United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Merck Sharp & Dohme Corp.
Principal Investigator: Linda Wagner-Weiner, MD University of Chicago
More Information

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00786409     History of Changes
Other Study ID Numbers: 15960A
MERCK: MISP for Gardasil#33598
First Posted: November 6, 2008    Key Record Dates
Last Update Posted: September 5, 2013
Last Verified: December 2012

Keywords provided by University of Chicago:

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs