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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
Results First Posted : February 15, 2018
Last Update Posted : February 15, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
University of Chicago

Study Description
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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 Phase
Systemic Lupus Erythematosus Biological: Gardasil Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: N/A
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
Actual Primary Completion Date : August 2010
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus Vaccines

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Anti-HPV 6 Seroconversion [ Time Frame: 7 months ]
    Percent Seropositive

  2. Anti-HPV 6 GMT [ Time Frame: 7 months ]
    Geometric mean titre in milli-Merck units per ml (mMu/ml)

  3. Anti-HPV 11 Seroconversion [ Time Frame: 7 months ]
    % Seropositive

  4. Anti-HPV 11 GMT [ Time Frame: 7 months ]
    Geometric mean titre in milli-Merck units per ml (mMu/ml)

  5. Anti-HPV 16 Seroconversion [ Time Frame: 7 months ]
    % Seropositive

  6. Anti-HPV 16 GMT [ Time Frame: 7 months ]
    Geometric mean titre in milli-Merck units per ml (mMu/ml)

  7. Anti-HPV 18 Seroconversion [ Time Frame: 7 months ]
    % Seropositive

  8. Anti-HPV 18 GMT [ Time Frame: 7 months ]
    Geometric mean titre in milli-Merck units per ml (mMu/ml)

  9. SLEDAI Change Score [ Time Frame: 7 months ]
    Systemic Lupus Erythematosus Disease Activity Index (SLEDAI): change from baseline to 7 months. The SLEDAI scale is a weighted sum of 16 clinical and 8 laboratory items. Scores range from 0 to 105 with higher scores indicating worse outcome. The variable analyzed here is the 7 month score minus the baseline score. Therefore negative values indicate an improvement in outcome.


Secondary Outcome Measures :
  1. Induction or Increase of Autoantibodies (Conversion From Negative Anti-RNP to Positive Anti-RNP) Anti-RNP [ Time Frame: 7 months ]
  2. Induction or Increase of Autoantibodies (Conversion From Negative Smith to Positive Smith) [ Time Frame: 7 months ]
  3. Induction or Increase of Autoantibodies (Conversion From Lupus Anticoagulant Negative to Lupus Anticoagulant Positive) [ Time Frame: 7 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 26 Years   (Child, Adult)
Sexes 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
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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


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

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00786409    
Other Study ID Numbers: 15960A
MERCK: MISP for Gardasil#33598
First Posted: November 6, 2008    Key Record Dates
Results First Posted: February 15, 2018
Last Update Posted: February 15, 2018
Last Verified: February 2018
Keywords provided by University of Chicago:
Lupus
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases