Clinical trial NCT00786409: 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
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Lupus Erythematosus
Keywords: Lupus
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2008-11-06
Enrollment: 27
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Anti-HPV 6 Seroconversion
timeFrame: 7 months
measure: Anti-HPV 6 GMT
timeFrame: 7 months
measure: Anti-HPV 11 Seroconversion
timeFrame: 7 months
measure: Anti-HPV 11 GMT
timeFrame: 7 months
measure: Anti-HPV 16 Seroconversion
timeFrame: 7 months
measure: Anti-HPV 16 GMT
timeFrame: 7 months
measure: Anti-HPV 18 Seroconversion
timeFrame: 7 months
measure: Anti-HPV 18 GMT
timeFrame: 7 months
measure: SLEDAI Change Score
timeFrame: 7 months
Secondary outcomes:
measure: Induction or Increase of Autoantibodies (Conversion From Negative Anti-RNP to Positive Anti-RNP) Anti-RNP
timeFrame: 7 months
measure: Induction or Increase of Autoantibodies (Conversion From Negative Smith to Positive Smith)
timeFrame: 7 months
measure: Induction or Increase of Autoantibodies (Conversion From Lupus Anticoagulant Negative to Lupus Anticoagulant Positive)
timeFrame: 7 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Linda Wagner-Weiner, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.