Arthritis
Conditions
Keywords
JIA, SEA syndrome, AS, psoriatic arthritis, HPV vaccine
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.
Interventions
OTHERBlood 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.
Sponsors
Merck Sharp & Dohme LLC
MetroHealth System, Ohio
The Cleveland Clinic
University of Chicago
University Hospitals Cleveland Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Masking description
The geometric mean titers are analyzed in a de-identified manner at Merck Contract laboratories.
Intervention model description
Open label vaccination study Gardasil vaccine (4 component).
Eligibility
Sex/Gender
FEMALE
Age
9 Years to 26 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive Serum GMTs at 7 Months (HPV06) | 7 months | dichotomized as negative or positive |
| Positive Serum GMTs at 7 Months (HPV11) | 7 months | dichotomized as negative or positive |
| Positive Serum GMTs at 7 Months (HPV16) | 7 months | dichotomized as negative or positive |
| Positive Serum GMTs at 7 Months (HPV18) | 7 months | dichotomized as negative or positive |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive Serum GMT (HVP16) | 12 months | dichotomized as negative or positive |
| Positive Serum GMT (HVP18) | 12 months | dichotomized as negative or positive |
| Positive Serum GMT (HPV06) | 24 months | — |
| Disease Flare | 2 years | increased arthritis requiring addition of steroids, intensification of NSAIDs or new DMARD or biological DMARD |
| Positive Serum GMT (HPV16) | 24 months | — |
| Positive Serum GMT (HPV18) | 24 months | — |
| Positive Serum GMT (HPV11) | 24 months | — |
| Peds QL | 2 years | worsening of \>30% from the prior visit |
| Positive Serum GMT (HVP06) | 12 months | dichotomized as negative or positive |
| Positive Serum GMT (HVP11) | 12 months | dichotomized as negative or positive |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from pediatric rheumatology clinics at UHCleveland Medical Center, Cleveland Clinic, the MetroHealth System, and the University of Chicago. Recruitment began in October of 2007 (IRB approval 10/22/2007) and finished in October of 2014.
Pre-assignment details
This is open label vaccine on top of current therapy.
Participants by arm
| Arm | Count |
|---|---|
| Aggregate of All Three Arms. All girls enrolled in the study 9-26 data were analyzed together as the original 72 subjects planned was not large enough to have statistically significant results once it became apparent that outcomes would need to be not only analyzed by subgroup but also by age 9-15 and 16-26. | 43 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Aggregate of All Three Arms. |
|---|---|
| Age, Categorical <=18 years | 39 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants |
| Race (NIH/OMB) White | 34 Participants |
| Sex: Female, Male Female | 43 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 43 |
| other Total, other adverse events | 21 / 43 |
| serious Total, serious adverse events | 1 / 43 |
Outcome results
Primary
Positive Serum GMTs at 7 Months (HPV06)
dichotomized as negative or positive
Time frame: 7 months
Population: 3 samples were lost in transport to lab
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JIA Except SJIA With Active Systemic Symptoms | Positive Serum GMTs at 7 Months (HPV06) | 34 participants |
Primary
Positive Serum GMTs at 7 Months (HPV11)
dichotomized as negative or positive
Time frame: 7 months
Population: 3 samples were lost in transport to lab
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JIA Except SJIA With Active Systemic Symptoms | Positive Serum GMTs at 7 Months (HPV11) | 35 participants |
Primary
Positive Serum GMTs at 7 Months (HPV16)
dichotomized as negative or positive
Time frame: 7 months
Population: 3 samples were lost in transport to lab
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JIA Except SJIA With Active Systemic Symptoms | Positive Serum GMTs at 7 Months (HPV16) | 35 participants |
Primary
Positive Serum GMTs at 7 Months (HPV18)
dichotomized as negative or positive
Time frame: 7 months
Population: 3 samples were lost in transport to lab
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JIA Except SJIA With Active Systemic Symptoms | Positive Serum GMTs at 7 Months (HPV18) | 35 participants |
Secondary
Disease Flare
increased arthritis requiring addition of steroids, intensification of NSAIDs or new DMARD or biological DMARD
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JIA Except SJIA With Active Systemic Symptoms | Disease Flare | 27 participants |
Secondary
Peds QL
worsening of \>30% from the prior visit
Time frame: 2 years
Secondary
Positive Serum GMT (HPV06)
Time frame: 24 months
Population: Not all participants agreed blood draw, and subject withdraw.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JIA Except SJIA With Active Systemic Symptoms | Positive Serum GMT (HPV06) | 11 participants |
Secondary
Positive Serum GMT (HPV11)
Time frame: 24 months
Population: Not all participants agreed blood draw, and subject withdraw.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JIA Except SJIA With Active Systemic Symptoms | Positive Serum GMT (HPV11) | 9 participants |
Secondary
Positive Serum GMT (HPV16)
Time frame: 24 months
Population: Not all participants agreed blood draw, and subject withdraw.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JIA Except SJIA With Active Systemic Symptoms | Positive Serum GMT (HPV16) | 11 participants |
Secondary
Positive Serum GMT (HPV18)
Time frame: 24 months
Population: Not all participants agreed blood draw, and subject withdraw.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JIA Except SJIA With Active Systemic Symptoms | Positive Serum GMT (HPV18) | 8 participants |
Secondary
Positive Serum GMT (HVP06)
dichotomized as negative or positive
Time frame: 12 months
Population: Not all participants agreed to blood draw, 2 missed visits and 2 drop outs.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JIA Except SJIA With Active Systemic Symptoms | Positive Serum GMT (HVP06) | 27 participants |
Secondary
Positive Serum GMT (HVP11)
dichotomized as negative or positive
Time frame: 12 months
Population: Not all participants agreed to blood draw, 2 missed visits and 2 drop outs.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JIA Except SJIA With Active Systemic Symptoms | Positive Serum GMT (HVP11) | 26 participants |
Secondary
Positive Serum GMT (HVP16)
dichotomized as negative or positive
Time frame: 12 months
Population: Not all participants agreed to blood draw, 2 missed visits and 2 drop outs.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JIA Except SJIA With Active Systemic Symptoms | Positive Serum GMT (HVP16) | 27 participants |
Secondary
Positive Serum GMT (HVP18)
dichotomized as negative or positive
Time frame: 12 months
Population: Not all participants agreed to blood draw, 2 missed visits and 2 drop outs.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JIA Except SJIA With Active Systemic Symptoms | Positive Serum GMT (HVP18) | 27 participants |