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Immunogenicity and Safety of HPV Vaccine Gardasil in Young Women

Primary Purpose

Systemic Lupus Erythematosus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gardasil
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Systemic Lupus Erythematosus focused on measuring Lupus

Eligibility Criteria

9 Years - 26 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Chicago

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Gardasil

Arm Description

30 patients will receive 0.5 ml Gardasil vaccine at months 0,2, and 6.

Outcomes

Primary Outcome Measures

Anti-HPV 6 Seroconversion
Percent Seropositive
Anti-HPV 6 GMT
Geometric mean titre in milli-Merck units per ml (mMu/ml)
Anti-HPV 11 Seroconversion
% Seropositive
Anti-HPV 11 GMT
Geometric mean titre in milli-Merck units per ml (mMu/ml)
Anti-HPV 16 Seroconversion
% Seropositive
Anti-HPV 16 GMT
Geometric mean titre in milli-Merck units per ml (mMu/ml)
Anti-HPV 18 Seroconversion
% Seropositive
Anti-HPV 18 GMT
Geometric mean titre in milli-Merck units per ml (mMu/ml)
SLEDAI Change Score
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

Induction or Increase of Autoantibodies (Conversion From Negative Anti-RNP to Positive Anti-RNP) Anti-RNP
Induction or Increase of Autoantibodies (Conversion From Negative Smith to Positive Smith)
Induction or Increase of Autoantibodies (Conversion From Lupus Anticoagulant Negative to Lupus Anticoagulant Positive)

Full Information

First Posted
November 5, 2008
Last Updated
February 14, 2018
Sponsor
University of Chicago
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00786409
Brief Title
Immunogenicity and Safety of HPV Vaccine Gardasil in Young Women
Official Title
Immunogenicity and Safety of the Quadrivalent HPV Vaccine Gardasil in Female Systemic Lupus Erythematosus Patients Aged 9-26
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Lupus

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gardasil
Arm Type
Other
Arm Description
30 patients will receive 0.5 ml Gardasil vaccine at months 0,2, and 6.
Intervention Type
Biological
Intervention Name(s)
Gardasil
Intervention Description
0.5 ml Gardasil vaccine will be administered to each patient at months 0,2 and 6.
Primary Outcome Measure Information:
Title
Anti-HPV 6 Seroconversion
Description
Percent Seropositive
Time Frame
7 months
Title
Anti-HPV 6 GMT
Description
Geometric mean titre in milli-Merck units per ml (mMu/ml)
Time Frame
7 months
Title
Anti-HPV 11 Seroconversion
Description
% Seropositive
Time Frame
7 months
Title
Anti-HPV 11 GMT
Description
Geometric mean titre in milli-Merck units per ml (mMu/ml)
Time Frame
7 months
Title
Anti-HPV 16 Seroconversion
Description
% Seropositive
Time Frame
7 months
Title
Anti-HPV 16 GMT
Description
Geometric mean titre in milli-Merck units per ml (mMu/ml)
Time Frame
7 months
Title
Anti-HPV 18 Seroconversion
Description
% Seropositive
Time Frame
7 months
Title
Anti-HPV 18 GMT
Description
Geometric mean titre in milli-Merck units per ml (mMu/ml)
Time Frame
7 months
Title
SLEDAI Change Score
Description
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.
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Induction or Increase of Autoantibodies (Conversion From Negative Anti-RNP to Positive Anti-RNP) Anti-RNP
Time Frame
7 months
Title
Induction or Increase of Autoantibodies (Conversion From Negative Smith to Positive Smith)
Time Frame
7 months
Title
Induction or Increase of Autoantibodies (Conversion From Lupus Anticoagulant Negative to Lupus Anticoagulant Positive)
Time Frame
7 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Wagner-Weiner, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17471531
Citation
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. doi: 10.1002/art.22667.
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Immunogenicity and Safety of HPV Vaccine Gardasil in Young Women

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