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| ID | Type | Description | Link |
|---|---|---|---|
| CHASE | Other Identifier | UHClevelandMC |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
| MetroHealth System, Ohio | OTHER |
| The Cleveland Clinic | OTHER |
| University of Chicago |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Flare | increased arthritis requiring addition of steroids, intensification of NSAIDs or new DMARD or biological DMARD | 2 years |
| Peds QL | worsening of >30% from the prior visit |
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Inclusion Criteria:
Exclusion Criteria:
Males are excluded from this study because GardasilΒ® is currently approved only for females.
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| Name | Affiliation | Role |
|---|---|---|
| Nora G Singer, MD | UHospitals Cleveland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States | ||
| University Hospitals Medical Center |
This is open label vaccine on top of current therapy.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | JIA Except SJIA 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 the clinical care. Study intervention consists of some Blood Draws for serum titers taken to measure antibody. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Positive Serum GMTs at 7 Months (HPV06) | dichotomized as negative or positive | 3 samples were lost in transport to lab | Posted | Number | participants | 7 months |
|
Data was collected for up to completion of the 24 month visit for patients that completed the study or the last known study visit.
In the initial protocol pregnancy after immunization was not excluded as an SAE. The label for Gardasil vaccine however does not say that patients need to avoid pregnancy following the immunization series. We had one pregnancy during the follow up period. The IRB protocol was amended to exclude pregnancy as an SAE once all vaccines are complete during the follow up period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pregnancy | Pregnancy, puerperium and perinatal conditions | NCI | Systematic Assessment | This pregnancy occurred months after the immunization series was completed. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Sinusitis, cold, cough |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nora G Singer | The MetroHealth System | 216-778-2138 | nsinger@metrohealth.org |
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| ID | Term |
|---|---|
| D001168 | Arthritis |
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| OTHER |
Open label vaccination study Gardasil vaccine (4 component).
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The geometric mean titers are analyzed in a de-identified manner at Merck Contract laboratories.
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|
| 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 |
| Cleveland |
| Ohio |
| 44106 |
| United States |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44189 | United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | Positive Serum GMTs at 7 Months (HPV11) | dichotomized as negative or positive | 3 samples were lost in transport to lab | Posted | Number | participants | 7 months |
|
|
|
| Primary | Positive Serum GMTs at 7 Months (HPV16) | dichotomized as negative or positive | 3 samples were lost in transport to lab | Posted | Number | participants | 7 months |
|
|
|
| Primary | Positive Serum GMTs at 7 Months (HPV18) | dichotomized as negative or positive | 3 samples were lost in transport to lab | Posted | Number | participants | 7 months |
|
|
|
| Secondary | Disease Flare | increased arthritis requiring addition of steroids, intensification of NSAIDs or new DMARD or biological DMARD | Posted | Number | participants | 2 years |
|
|
|
| Secondary | Peds QL | worsening of >30% from the prior visit | Not Posted | 2 years | Participants |
| Secondary | Positive Serum GMT (HVP06) | dichotomized as negative or positive | Not all participants agreed to blood draw, 2 missed visits and 2 drop outs. | Posted | Number | participants | 12 months |
|
|
|
| Secondary | Positive Serum GMT (HVP11) | dichotomized as negative or positive | Not all participants agreed to blood draw, 2 missed visits and 2 drop outs. | Posted | Number | participants | 12 months |
|
|
|
| Secondary | Positive Serum GMT (HVP16) | dichotomized as negative or positive | Not all participants agreed to blood draw, 2 missed visits and 2 drop outs. | Posted | Number | participants | 12 months |
|
|
|
| Secondary | Positive Serum GMT (HVP18) | dichotomized as negative or positive | Not all participants agreed to blood draw, 2 missed visits and 2 drop outs. | Posted | Number | participants | 12 months |
|
|
|
| Secondary | Positive Serum GMT (HPV06) | Not all participants agreed blood draw, and subject withdraw. | Posted | Number | participants | 24 months |
|
|
|
| Secondary | Positive Serum GMT (HPV11) | Not all participants agreed blood draw, and subject withdraw. | Posted | Number | participants | 24 months |
|
|
|
| Secondary | Positive Serum GMT (HPV16) | Not all participants agreed blood draw, and subject withdraw. | Posted | Number | participants | 24 months |
|
|
|
| Secondary | Positive Serum GMT (HPV18) | Not all participants agreed blood draw, and subject withdraw. | Posted | Number | participants | 24 months |
|
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|
| 0 |
| 43 |
| 1 |
| 43 |
| 21 |
| 43 |
|
|
| Achiness | Infections and infestations | Systematic Assessment | fatigue/flu-like symptoms |
|
| nausea or diarrhea | Gastrointestinal disorders | Systematic Assessment | stomach upset |
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| arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment | stiffness |
|
| lightheadedness | Vascular disorders | Systematic Assessment | dizziness |
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| fever | Infections and infestations | Systematic Assessment |
|
| rash | Skin and subcutaneous tissue disorders | Systematic Assessment | urticaria |
|
| bruise | Musculoskeletal and connective tissue disorders | Systematic Assessment | contusion |
|
| shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| strep throat | Infections and infestations | Systematic Assessment |
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| syncope vaso-vagal | Vascular disorders | Systematic Assessment |
|
| flare | Musculoskeletal and connective tissue disorders | Systematic Assessment | arthritis flare, enthesitis flare |
|
| dry socket following extraction | Injury, poisoning and procedural complications | Systematic Assessment | complications wisdom tooth extraction |
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| otalgia | Ear and labyrinth disorders | Systematic Assessment |
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| Herpes zoster | Infections and infestations | Systematic Assessment | Shingles |
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| Injection site pain | Injury, poisoning and procedural complications | Systematic Assessment | injection Θ™ite reaction |
|
| insomnia | General disorders | Systematic Assessment | sleep disorder |
|
| musculoskeletal pain due to MVA injury | Injury, poisoning and procedural complications | Systematic Assessment | joint pain due to car accident |
|
| warts, plantar | Infections and infestations | Systematic Assessment |
|
| thrush | Infections and infestations | Systematic Assessment | oral candidiasis |
|
| vomiting | Gastrointestinal disorders | Systematic Assessment | emesis, stomach flu |
|
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| D013166 |
| Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |