Immunogenicity and Safety of HPV Vaccine Gardasil in Young Women

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the immunogenicity and safety of the HPV vaccine Gardasil in young women.

Detailed Description
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Female patients with systemic lupus erythematosus (SLE) have been found have higher rates of persistent HPV infections and precancerous lesions compared to the healthy population. The HPV vaccine Gardasil has been found to be safe and efficacious in females aged 9 to 26 years. There are no data on the immunogenicity and safety of Gardasil in females with SLE. Immune dysfunction related to SLE itself and the immunosuppression secondary to treatment of SLE might prevent patients with SLE from developing an adequate immune response to the vaccine. Also, theoretically, the vaccine might induce a disease exacerbation or production of new autoantibodies. The purpose of this study is to evaluate immunogenicity and safety of Gardasil and its effects on autoantibody profile in female SLE patients aged 9-26 years

Official Title
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Immunogenicity and Safety of the Quadrivalent HPV Vaccine Gardasil in Female Systemic Lupus Erythematosus Patients Aged 9-26

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Biological: Gardasil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 26 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Gardasil<br>30 patients will receive 0.5 ml Gardasil vaccine at months 0,2, and 6. | Biological: Gardasil<br>* 0.5 ml Gardasil vaccine will be administered to each patient at months 0,2 and 6.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-HPV 6 Seroconversion | Percent Seropositive | 7 months | 
| Anti-HPV 6 GMT | Geometric mean titre in milli-Merck units per ml (mMu/ml) | 7 months | 
| Anti-HPV 11 Seroconversion | % Seropositive | 7 months | 
| Anti-HPV 11 GMT | Geometric mean titre in milli-Merck units per ml (mMu/ml) | 7 months | 
| Anti-HPV 16 Seroconversion | % Seropositive | 7 months | 
| Anti-HPV 16 GMT | Geometric mean titre in milli-Merck units per ml (mMu/ml) | 7 months | 
| Anti-HPV 18 Seroconversion | % Seropositive | 7 months | 
| Anti-HPV 18 GMT | Geometric mean titre in milli-Merck units per ml (mMu/ml) | 7 months | 
| SLEDAI Change Score | Systemic Lupus Erythematosus Disease Activity Index (SLEDAI): change from baseline to 7 months. The SLEDAI scale is a weighted sum of 16 clinical and 8 laboratory items. Scores range from 0 to 105 with higher scores indicating worse outcome. The variable analyzed here is the 7 month score minus the baseline score. Therefore negative values indicate an improvement in outcome. | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Induction or Increase of Autoantibodies (Conversion From Negative Anti-RNP to Positive Anti-RNP) Anti-RNP |  | 7 months | 
| Induction or Increase of Autoantibodies (Conversion From Negative Smith to Positive Smith) |  | 7 months | 
| Induction or Increase of Autoantibodies (Conversion From Lupus Anticoagulant Negative to Lupus Anticoagulant Positive) |  | 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lupus