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

NCT00573651 | Completed Results DMC

• 2 other identifiers: Gardasil in JIACHASE
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Arthritis

Keywords

JIA; SEA syndrome; AS; psoriatic arthritis; HPV vaccine

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (10)

• Disease Flare

  2 years

• Peds QL

  2 years

• Positive Serum GMT (HVP06)

  12 months

• Positive Serum GMT (HVP11)

  12 months

• Positive Serum GMT (HVP16)

  12 months

Study Arms (1)

JIA except SJIA with active systemic symptoms

OTHER

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

Interventions

Blood Draws for Serum Titers 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.

JIA except SJIA with active systemic symptoms

Eligibility Criteria

• Age: 9 Years - 26 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Female patients, age 9-26 years, with polyarticular JIA, pauciarticular JIA, and sero-negative arthritis.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Merck Sharp & Dohme LLC: collaborator
• MetroHealth System, Ohio: collaborator
• The Cleveland Clinic: collaborator
• University of Chicago: collaborator

Study Sites (4)

University of Chicago

Chicago, Illinois, 60637, United States

Location

University Hospitals Medical Center

Cleveland, Ohio, 44106, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44189, United States

Location

MeSH Terms

Conditions

Arthritis; Arthritis, Psoriatic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Nora G Singer
• Organization: The MetroHealth System

nsinger@metrohealth.org

216-778-2138

Study Officials

• Nora G Singer, MD

  UHospitals Cleveland

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The geometric mean titers are analyzed in a de-identified manner at Merck Contract laboratories.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Model Details: Open label vaccination study Gardasil vaccine (4 component).

Study Record Dates

• First Submitted: December 13, 2007
• First Posted: December 14, 2007
• Study Start: November 1, 2007
• Primary Completion: October 20, 2014
• Study Completion: October 20, 2014
• Last Updated: July 5, 2024
• Results First Posted: July 5, 2024

Record last verified: 2024-01

Locations

US (4)