Immunogenicity and Safety of HPV Vaccine Gardasil in Young Women

NCT ID: NCT00786409

Last Updated: 2018-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2011-12-31

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

Conditions

Systemic Lupus Erythematosus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Gardasil

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

Group Type: OTHER

Gardasil

Intervention Type: BIOLOGICAL

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

Interventions

Gardasil

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

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Linda Wagner-Weiner, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 17471531 (View on PubMed)

Other Identifiers

MERCK: MISP for Gardasil#33598

Identifier Type: -

Identifier Source: secondary_id

15960A

Identifier Type: -

Identifier Source: org_study_id