Randomized, Double Blind Trial of the Quadrivalent HPV Vaccine to Improve Responses to LEEP Treatment of Cervical HSIL
Condition: Cervical High Grade Squamous Intraepithelial Lesion
MeSH terms: Squamous Intraepithelial Lesions of the Cervix; Carcinoma, Squamous Cell; Carcinoma in Situ; Uterine Cervical Dysplasia
Intervention: Human Papillomavirus vaccine
Intervention description: The participants receive the qHPV vaccine at entry, week 4 and week 26
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 180.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HSIL; CIN; HPV; HPV vaccination; gardasil; HIV; cervical dysplasia; LEEP; cervical cancer

Summary:

      Cervical cancer occurs commonly in HIV-infected women in South Africa. These women have poor
      response to treatment of cervical cancer precursors. This study will test whether giving the
      quadrivalent vaccine to women prior to surgical treatment of the cervical cancer precursor
      will improve outcomes. We hypothesize that pre-treatment HPV vaccine will result in a reduced
      occurrence or cervical cancer precursors in follow-up.
    

Eligibility criteria:

        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