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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2014-10-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Arthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open label vaccination study Gardasil vaccine (4 component).

Primary Study Purpose

OTHER

Blinding Strategy

NONE

The geometric mean titers are analyzed in a de-identified manner at Merck Contract laboratories.

Study Groups

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JIA except SJIA with active systemic symptoms

Females age 9-26 with JIA of all types that have had arthritis and do not have active systemic symptoms. All study subjects are receiving the Gardasil vaccine as part of their clinical care. The study observes outcomes related to this clinical care. Study intervention consists of some Blood Draws for serum titers taken to measure antibody.

Group Type OTHER

Blood Draws for Serum Titers

Intervention Type OTHER

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.

Interventions

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Blood Draws for Serum Titers

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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

9 Years

Maximum Eligible Age

26 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No