Randomized, Double Blind Trial of the Quadrivalent HPV Vaccine to Improve Responses to LEEP Treatment of Cervical HSIL

Exclusion Criteria

• •1. History or current biopsy diagnosis of invasive or microinvasive cervical, vaginal, vulvar, anal or oropharyngeal cancer
• •2. Prior hysterectomy
• •3. Cervical cryotherapy or LEEP/LEETZ within one year of entry.
• •4. Cervical, vulvar, or vaginal lesions suspicious for cancer, unless biopsies show no invasive cancer
• •5. Prior receipt of one or more doses of an HPV vaccine.
• •6. Receipt of anticoagulants other than aspirin or nonsteroidal anti-inflammatory drugs (NSAIDS) within 14 days prior to entry.
• •7. Known allergy/sensitivity or any hypersensitivity to yeast or any of the components of the study product or its formulation (see section 5.2 for a list of components).
• •8. Hemophilia or other bleeding diatheses.
• •9. Use of any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids, other than inhaled corticosteroids or prednisone ≤ 10 mg (or equivalent) , investigational vaccines, interleukins, interferons, growth factors, or intravenous immunoglobulin (IVIG) within 45 days prior to study entry.
• •10. Breastfeeding
• •11. Less than 3 months post-partum