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

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

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.

Study Overview

• Status: Completed
• Conditions: Arthritis
• Intervention / Treatment: Other: Blood Draws for Serum Titers

Detailed Description

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
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • MetroHealth Medical Center
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Medical Center
    • Cleveland, Ohio, United States, 44189
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 26 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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.

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive Serum GMTs at 7 Months (HPV06)	dichotomized as negative or positive	7 months
Positive Serum GMTs at 7 Months (HPV11)	dichotomized as negative or positive	7 months
Positive Serum GMTs at 7 Months (HPV16)	dichotomized as negative or positive	7 months
Positive Serum GMTs at 7 Months (HPV18)	dichotomized as negative or positive	7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peds QL	worsening of >30% from the prior visit	2 years
Disease Flare	increased arthritis requiring addition of steroids, intensification of NSAIDs or new DMARD or biological DMARD	2 years
Positive Serum GMT (HVP06)	dichotomized as negative or positive	12 months
Positive Serum GMT (HVP11)	dichotomized as negative or positive	12 months
Positive Serum GMT (HVP16)	dichotomized as negative or positive	12 months
Positive Serum GMT (HVP18)	dichotomized as negative or positive	12 months
Positive Serum GMT (HPV06)		24 months
Positive Serum GMT (HPV11)		24 months
Positive Serum GMT (HPV16)		24 months
Positive Serum GMT (HPV18)		24 months

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Collaborators: Merck Sharp & Dohme LLC; University of Chicago; The Cleveland Clinic; The MetroHealth System
• Investigators: Study Director: Nora G Singer, MD, UHospitals Cleveland

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): October 20, 2014
• Study Completion (Actual): October 20, 2014

Study Registration Dates

• First Submitted: December 13, 2007
• First Submitted That Met QC Criteria: December 13, 2007
• First Posted (Estimated): December 14, 2007

Study Record Updates

• Last Update Posted (Actual): July 5, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: JIA; psoriatic arthritis; HPV vaccine; AS; SEA syndrome
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Juvenile
• Other Study ID Numbers: Gardasil in JIA; CHASE (Other Identifier: UHClevelandMC)