Study to Determine if Gardasil Vaccine is Safe and Effective in Lupus Patients
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Gardasil
Intervention description: 0.5 ml Gardasil vaccine in single dose prefilled syringes at Visit 2, Visit 4 and Visit 6
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Lupus

Summary:

      Cervical neoplasia is increased in women with SLE most likely due to cervical infection with
      human papilloma virus (HPV). 70% of cervical cancer is caused by HPV types 16 and 18.
      Gardasil vaccine prevents cervical infection with HPV types 16 and 18. Thus lupus patients
      (who are susceptible to cervical cancer) may benefit from getting Gardasil vaccine which can
      prevent cervical cancer. Vaccines are generally safe and efficacious in SLE but no studies
      have been done on the use of this vaccine in SLE. The investigators hypothesize that Gardasil
      vaccine is safe and effective in SLE. This study will look at vaccine safety in patients with
      mild to moderate and minimally active or inactive SLE and measure how well they make
      protective antibodies after receiving the vaccine. In other words this will check how well
      the vaccine works in SLE.
    

Eligibility criteria:

        Inclusion Criteria:

        Diagnosis of systemic lupus erythematosis (SLE) by the American College of Rheumatology
        (ACR) Criteria.

        History of a positive antinuclear antibody (ANA) test result at any time in the past.

        40 participants with history of mild to moderate SLE disease Minimally active or inactive
        SLE disease, i.e., (Safety of Estrogens in Lupus Erythematosis National Assessment (SELENA)
        Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), SELENA-SLEDAI ≤2 at the start
        of the study.

        Age ≥ 18 years and ≤ 50 years. Gender: females Ability to provide informed consent.
        Maintenance Prednisone dose ≤ 15 mg/day. Plaquenil ≤ 400 mg/day.

        Exclusion Criteria:

        Hypersensitivity to any vaccine component Active infections including but not limited to
        human immunodeficiency virus (HIV positive), Hepatitis B or C, tuberculosis.

        Positive purified protein derivative (PPD) test results without evidence of prior treatment
        or administration of bacilli Calmette-Guerin (BCG) vaccine. A positive PPD is defined as ≥
        5 mm induration 24-38 hours after receiving 5TU (TU=tuberculin units) of PPD.

        Pregnancy or desire to become pregnant during the study period. Breast feeding. Inability
        to complete the immunization series. Received any blood product or component in the
        previous 6 months before enrollment.

        Received any inactivated vaccine product within 14 days before enrollment. Received any
        live vaccine product within 21 days before enrollment.

        Fever (temperature > 100°F) at the time of enrollment. Inability to provided informed
        consent.