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

Inclusion Criteria:

1. HIV infection
2. Women aged ≥ 18 years.
3. Cervical HSIL on biopsy (i.e. CIN2 and/or CIN3)
4. For participants of reproductive potential, negative serum or urine pregnancy test
5. All study participants must agree not to participate in a conception process (e.g., active attempt to become pregnant or in vitro fertilization) during study participation (from the time of study entry until week 52).

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