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

University Hospitals Cleveland Medical Center43 enrolled

Overview

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.

Each individual subject's participation is scheduled to 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Arthritis

Interventions

Blood Draws for Serum TitersOTHER

All study subjects are receiving the Gardasil vaccine as part of their clinical care. The Gardasil vaccine is not given because of study participation. The study observes outcomes related to this clinical care. Study intervention consists of some blood samples taken to measure antibody and RNA titers. Other study specific procedures performed include Questionnaires and observational data.

Eligibility

Sex: FEMALEMin age: 9 YearsMax age: 26 Years

Medical Language ↔ Plain English

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.

Locations (4)

University of Chicago

Chicago, Illinois, United States

University Hospitals Medical Center

Cleveland, Ohio, United States

MetroHealth Medical Center

Cleveland, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Positive Serum GMTs at 7 Months (HPV06)

dichotomized as negative or positive

Time frame: 7 months

Positive Serum GMTs at 7 Months (HPV11)

dichotomized as negative or positive

Time frame: 7 months

Positive Serum GMTs at 7 Months (HPV16)

dichotomized as negative or positive

Time frame: 7 months

Positive Serum GMTs at 7 Months (HPV18)

dichotomized as negative or positive

Time frame: 7 months

Secondary Outcomes

Disease Flare

increased arthritis requiring addition of steroids, intensification of NSAIDs or new DMARD or biological DMARD

Time frame: 2 years

Peds QL

worsening of \>30% from the prior visit

Time frame: 2 years

Positive Serum GMT (HVP06)

dichotomized as negative or positive

Time frame: 12 months

Positive Serum GMT (HVP11)

dichotomized as negative or positive

Time frame: 12 months

Positive Serum GMT (HVP16)

dichotomized as negative or positive

Time frame: 12 months

Data from ClinicalTrials.gov

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