N/A
N=43
Safety and Efficacy of Gardasil in Females With Juvenile Idiopathic Arthritis (JIA)/Seronegative Arthritis
Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT00573651 ↗Enrolled (actual)
43
Serious AEs
2.3%
Results posted
Jul 2024
Primary outcome: Primary: Positive Serum GMTs at 7 Months (HPV06) — 34 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Blood Draws for Serum Titers (Other)
- Age
- Pediatric, Adult · 9+ yrs
- Sex
- Female
- Sponsor
- University Hospitals Cleveland Medical Center
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Positive Serum GMTs at 7 Months (HPV06) |
34 | — |
| PRIMARY Positive Serum GMTs at 7 Months (HPV11) |
35 | — |
| PRIMARY Positive Serum GMTs at 7 Months (HPV16) |
35 | — |
| PRIMARY Positive Serum GMTs at 7 Months (HPV18) |
35 | — |
| SECONDARY Disease Flare |
27 | — |
| SECONDARY Peds QL |
— | — |
| SECONDARY Positive Serum GMT (HVP06) |
27 | — |
| SECONDARY Positive Serum GMT (HVP11) |
26 | — |
| SECONDARY Positive Serum GMT (HVP16) |
27 | — |
| SECONDARY Positive Serum GMT (HVP18) |
27 | — |
| SECONDARY Positive Serum GMT (HPV06) |
11 | — |
| SECONDARY Positive Serum GMT (HPV11) |
9 | — |
| SECONDARY Positive Serum GMT (HPV16) |
11 | — |
| SECONDARY Positive Serum GMT (HPV18) |
8 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00573651). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.