Vaccine Therapy with or without Imiquimod in Treating Patients with High-Grade Cervical Intraepithelial Neoplasia

Inclusion Criteria

• Patients with high-grade cervical intraepithelial lesions (CIN2/3) confirmed by colposcopy, biopsy, and review of the biopsy pathology slides by two pathologists
• Patients whose lesions are HPV16+ by polymerase chain reaction (PCR) (treatment groups 1, 2, 3 and 5); group 4 (imiquimod alone: 12 HPV16+ subjects, 36 HPV16 negative [-] subjects)
• Patients who are age 18 or older
• Patients who have measurable disease after diagnostic biopsy
• An approved informed consent and authorization permitting release of personal health information must be signed by the patient or guardian
• Patients who are immunocompetent
• Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception during the study

Exclusion Criteria

• Patients with evidence of concurrent adenocarcinoma-in-situ
• Patients with serious, concomitant disorder, including active systemic infection, autoimmune disease, proven or suspected immunosuppressive disorder or any other major medical illnesses of the cardiovascular or respiratory system, concurrent malignancy except for nonmelanoma skin lesions
• Patients who are human immunodeficiency virus (HIV) seropositive
• Patients who take immunosuppressive medication, i.e. steroid therapy or other immunosuppressive/immunomodulating drugs (e.g. Cyclosporine) within 2 months prior to first study drug injection
• Patients who are pregnant, planning pregnancy, or breast feeding
• Patients who are participating in another experimental protocol during the study period (last intake of investigational drug within 6 months prior to first study drug injection)
• SUBJECTS ENROLLED IN THE TREATMENT GROUPS RECEIVING VACCINE ONLY (NOT THE IMIQUIMOD GROUP):
• Patients with a history of severe allergy including eczema or other exfoliative skin disorder or active skin diseases such as psoriasis, lichen planus, severe acneiform rash, impetigo, varicella zoster, or sepsis among patients or among close social, sexual or domestic contacts; patients with burns or other traumatic or pruritic skin conditions or open wounds should not receive the vaccine until the condition has resolved; surgical scars must be healed
• Patients with active eczema during the last 12 months
• Patients who have an allergy to eggs
• Patients who are in close social contact with children under 5 years old
• Patients who are in close social/domestic contact with a pregnant woman
• Patients who have been previously vaccinated with vaccinia
• Patients with evidence/history of cardiac disease including congestive heart failure, symptomatic arrhythmia not controlled by medication, unstable angina or cardiac disease, history of acute myocardial infarction (MI) or cerebrovascular accident (CVA) within the past six months