Immunogenicity and Safety of HPV Vaccine Gardasil in Young Women

University of Chicago27 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Systemic Lupus Erythematosus

Interventions

GardasilBIOLOGICAL

0.5 ml Gardasil vaccine will be administered to each patient at months 0,2 and 6.

Eligibility

Sex: FEMALEMin age: 9 YearsMax age: 26 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Chicago

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Anti-HPV 6 Seroconversion

Percent Seropositive

Time frame: 7 months

Anti-HPV 6 GMT

Geometric mean titre in milli-Merck units per ml (mMu/ml)

Time frame: 7 months

Anti-HPV 11 Seroconversion

% Seropositive

Time frame: 7 months

Anti-HPV 11 GMT

Geometric mean titre in milli-Merck units per ml (mMu/ml)

Time frame: 7 months

Anti-HPV 16 Seroconversion

% Seropositive

Time frame: 7 months

Anti-HPV 16 GMT

Geometric mean titre in milli-Merck units per ml (mMu/ml)

Time frame: 7 months

Anti-HPV 18 Seroconversion

% Seropositive

Time frame: 7 months

Anti-HPV 18 GMT

Geometric mean titre in milli-Merck units per ml (mMu/ml)

Time frame: 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.

Time frame: 7 months

Data from ClinicalTrials.gov

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Immunogenicity and Safety of HPV Vaccine Gardasil in Young Women

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes