Immunogenicity and Safety of HPV Vaccine Gardasil in Young Women

The University of Chicago

Status: Completed

Conditions: Systemic Lupus Erythematosus

Treatments: Biological: Gardasil

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00786409

MERCK: MISP for Gardasil#33598

15960A

Details and patient eligibility

About

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

Full 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

Enrollment: 27 patients

Sex: Female

Ages: 9 to 26 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Gardasil

Other group

Description:

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

Treatment:

Biological: Gardasil