Clinical trial NCT00573651: Safety and Efficacy of Gardasil in Females With Juvenile Idiopathic Arthritis (JIA)/Seronegative Arthritis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis
Keywords: JIA
SEA syndrome
AS
psoriatic arthritis
HPV vaccine
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: MetroHealth System, Ohio
name: The Cleveland Clinic
name: University of Chicago
First posted: 2007-12-14
Enrollment: 43
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label vaccination study Gardasil vaccine (4 component).
Primary purpose: OTHER

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.

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.

Eligibility 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.

Primary outcomes:
measure: Positive Serum GMTs at 7 Months (HPV06)
timeFrame: 7 months
measure: Positive Serum GMTs at 7 Months (HPV11)
timeFrame: 7 months
measure: Positive Serum GMTs at 7 Months (HPV16)
timeFrame: 7 months
measure: Positive Serum GMTs at 7 Months (HPV18)
timeFrame: 7 months
Secondary outcomes:
measure: Disease Flare
timeFrame: 2 years
measure: Peds QL
timeFrame: 2 years
measure: Positive Serum GMT (HVP06)
timeFrame: 12 months
measure: Positive Serum GMT (HVP11)
timeFrame: 12 months
measure: Positive Serum GMT (HVP16)
timeFrame: 12 months
measure: Positive Serum GMT (HVP18)
timeFrame: 12 months
measure: Positive Serum GMT (HPV06)
timeFrame: 24 months
measure: Positive Serum GMT (HPV11)
timeFrame: 24 months
measure: Positive Serum GMT (HPV16)
timeFrame: 24 months
measure: Positive Serum GMT (HPV18)
timeFrame: 24 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Cleveland
country: United States
facility: University Hospitals Medical Center
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: UHospitals Cleveland
name: Nora G Singer, MD
role: STUDY_DIRECTOR
References: