N/A
N=27
Immunogenicity and Safety of HPV Vaccine Gardasil in Young Women
Systemic Lupus Erythematosus
Bottom Line
View on ClinicalTrials.gov: NCT00786409 ↗Enrolled (actual)
27
Serious AEs
7.4%
Results posted
Feb 2018
Primary outcome: Primary: Anti-HPV 6 Seroconversion — 93.8 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Gardasil (Biological)
- Age
- Pediatric, Adult · 9+ yrs
- Sex
- Female
- Sponsor
- University of Chicago
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anti-HPV 6 Seroconversion |
93.8 | — |
| PRIMARY Anti-HPV 6 GMT |
427.0 | — |
| PRIMARY Anti-HPV 11 Seroconversion |
100 | — |
| PRIMARY Anti-HPV 11 GMT |
596.7 | — |
| PRIMARY Anti-HPV 16 Seroconversion |
100 | — |
| PRIMARY Anti-HPV 16 GMT |
2263.2 | — |
| PRIMARY Anti-HPV 18 Seroconversion |
93.8 | — |
| PRIMARY Anti-HPV 18 GMT |
331.9 | — |
| PRIMARY SLEDAI Change Score |
-1.65 | — |
| SECONDARY Induction or Increase of Autoantibodies (Conversion From Negative Anti-RNP to Positive Anti-RNP) Anti-RNP |
— | — |
| SECONDARY Induction or Increase of Autoantibodies (Conversion From Negative Smith to Positive Smith) |
— | — |
| SECONDARY Induction or Increase of Autoantibodies (Conversion From Lupus Anticoagulant Negative to Lupus Anticoagulant Positive) |
2 | — |
Summary
The purpose of this study is to evaluate the immunogenicity and safety of the HPV vaccine Gardasil in young women.
Eligibility Criteria
Inclusion Criteria
- Age: 9 to 26 years of age
- Gender: Female
- All patients must fulfill the revised American College of Rheumatology Classification Criteria for SLE diagnosis.
- Current SLEDAI score ≤ 6
- Written, witnessed informed consent and/or assent will be obtained from the subject and the subject's parents (if under 18 years of age) or legally acceptable representative prior to enrollment
Exclusion Criteria
- Acute exacerbation of disease within past 30 days which required increase in corticosteroid dose, initiation of a new immunosuppressive medication, or hospitalization
- Current SLEDAI score > 6
- Patients who have received rituximab in the last 6 months, or are currently on cyclophosphamide treatment
- History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine
- Previous administration of any HPV vaccine
Data sourced from ClinicalTrials.gov (NCT00786409). 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.