Immunogenicity and Safety of HPV Vaccine Gardasil in Young Women

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00786409
First received: November 5, 2008
Last updated: September 4, 2013
Last verified: December 2012
  Purpose

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


Condition Intervention
Systemic Lupus Erythematosus
Biological: Gardasil

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Primary outcome measures are Mean Geometric HPV Antibody Titers and a change in SLE disease activity [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secondary outcome measure is induction or increase of autoantibodies [ Time Frame: 7 months ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: November 2008
Study Completion Date: December 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Gardasil
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.
Other Name: 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

  Eligibility

Ages Eligible for Study:   9 Years to 26 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00786409

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

Publications:
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00786409     History of Changes
Other Study ID Numbers: 15960A, MERCK: MISP for Gardasil#33598
Study First Received: November 5, 2008
Last Updated: September 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Lupus

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 18, 2014