NCT00786409

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
6.2 years until next milestone

Results Posted

Study results publicly available

February 15, 2018

Completed
Last Updated

February 15, 2018

Status Verified

February 1, 2018

Enrollment Period

1.7 years

First QC Date

November 5, 2008

Results QC Date

November 8, 2016

Last Update Submit

February 14, 2018

Conditions

Systemic Lupus Erythematosus

Keywords

Lupus

Outcome Measures

Primary Outcomes (9)

  • Anti-HPV 6 Seroconversion

    Percent Seropositive

    7 months

  • Anti-HPV 6 GMT

    Geometric mean titre in milli-Merck units per ml (mMu/ml)

    7 months

  • Anti-HPV 11 Seroconversion

    % Seropositive

    7 months

  • Anti-HPV 11 GMT

    Geometric mean titre in milli-Merck units per ml (mMu/ml)

    7 months

  • Anti-HPV 16 Seroconversion

    % Seropositive

    7 months

  • Anti-HPV 16 GMT

    Geometric mean titre in milli-Merck units per ml (mMu/ml)

    7 months

  • Anti-HPV 18 Seroconversion

    % Seropositive

    7 months

  • Anti-HPV 18 GMT

    Geometric mean titre in milli-Merck units per ml (mMu/ml)

    7 months

  • 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.

    7 months

Secondary Outcomes (3)

  • Induction or Increase of Autoantibodies (Conversion From Negative Anti-RNP to Positive Anti-RNP) Anti-RNP

    7 months

  • Induction or Increase of Autoantibodies (Conversion From Negative Smith to Positive Smith)

    7 months

  • Induction or Increase of Autoantibodies (Conversion From Lupus Anticoagulant Negative to Lupus Anticoagulant Positive)

    7 months

Study Arms (1)

Gardasil

OTHER

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

Biological: Gardasil

Interventions

GardasilBIOLOGICAL

0.5 ml Gardasil vaccine will be administered to each patient at months 0,2 and 6.

Gardasil

Eligibility Criteria

Age9 Years - 26 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

  • 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.

    PMID: 17471531BACKGROUND

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Vaccines, CombinedVaccinesBiological ProductsComplex MixturesPapillomavirus VaccinesViral Vaccines

Results Point of Contact

Title
Linda Wagner-Weinter, MD
Organization
University of Chicago
lww@uchicago.edu
773-702-2245

Study Officials

  • Linda Wagner-Weiner, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2008

First Posted

November 6, 2008

Study Start

November 1, 2008

Primary Completion

August 1, 2010

Study Completion

December 1, 2011

Last Updated

February 15, 2018

Results First Posted

February 15, 2018

Record last verified: 2018-02

Locations

US(1)