Safety and Efficacy of Gardasil in Females With Juvenile Idiopathic Arthritis (JIA)/Seronegative Arthritis

Condition(s) targeted: Arthritis

Intervention: Quadrivalent HPV vaccine (Gardasil®) (Biological)

Phase: Phase 4

Status: Recruiting

Sponsored by: University Hospitals of Cleveland

Official(s) and/or principal investigator(s):
Nora G Singer, MD, Principal Investigator, Affiliation: UHospitals Cleveland

Overall contact:
Michelle Wallette, Phone: 216-591-1443, Ext: 15, Email: michelle.wallette@uhhospitals.org

The purpose of this research study is to see if patients with juvenile idiopathic arthritis or seronegative arthritis (and related conditions) mount protective immune responses to the human papillomavirus (HPV) vaccine called Gardasil. The researchers also want to monitor for any increase in disease activity following receipt of the vaccine.

Official title: Pilot Study of the Safety and Efficacy of Quadrivalent Human Papillomavirus Vaccine (Gardasil®) in Female Subjects With Juvenile Idiopathic Arthritis (JIA)/ Seronegative Arthritis

Study design: Treatment, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Serum GMTs at 7 months

Secondary outcome:

Disease flare

Peds QL

Measure serum GMT

Measure serum GMT

Detailed description: The study will last approximately two years. Patients will be given Gardasil injections at months 0, 2, and 6. Patients will have geometric mean titers (GMT) measured at 7, 12, and 24 months. Questionnaires about health and function will also be completed at each visit.

Minimum age: 9 Years. Maximum age: 26 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Female patients, age 9-26 years, with polyarticular JIA, pauciarticular JIA, and

sero-negative arthritis.

Exclusion Criteria:

- Pregnancy

- Known allergy/sensitivity or any hypersensitivity to yeast or components of study

drug or their formulation

- Systemic onset JIA with active systemic symptoms (systemic onset JIA with

polyarticular features but no fever or rash may be included).

- Prior vaccination against HPV

- Known HPV infection

- Current or history of cervical cancer or cervical intraepithelial neoplasia (CIN).

Males are excluded from this study because Gardasil® is currently approved only for females.

Michelle Wallette, Phone: 216-591-1443, Ext: 15, Email: michelle.wallette@uhhospitals.org

University Hospitals Case Medical Center, Cleveland, Ohio 44106, United States; Recruiting

Starting date: November 2007
Ending date: November 2011
Last updated: June 30, 2008