Phase II Study of HPV Therapeutic Vaccine in HPV Infected Women With Normal Cytology or ASCUS/LSIL

Inclusion criteria

• A subject will be eligible for inclusion in this study if the following criteria apply:

• Subject is female between the ages of 25 and 50 years (inclusive).
• Subject is pre-menopausal .
• Subject must have cervical HPV 16 and/or 18 infection confirmed by RT-PCR
• Subject has a cervical cytological evaluation with a normal, ASCUS or LSIL result at baseline.
• Subject has employed highly effective contraception the month prior to the first vaccination and will agree to employ highly effective contraception for at least 12 months after the first vaccination. .
• Subject is in general good health based on medical history and physical examination.
• Subject is able to communicate effectively with study personnel and is considered reliable, willing, and cooperative in terms of compliance with the protocol requirements.
• Subject voluntarily gives written informed consent to participate in the study.

Exclusion criteria

• Subject has a current acute or chronic disease, other than infection with HPV, which would be expected to interfere with the planned evaluations of response
• Subject has vaginal atrophy with or without topical hormonal therapies or systemic selective estrogen receptor modulators (SERMs).
• Subject has prior exposure to HPV prophylactic vaccine or subject has participated in the past in another vaccination clinical trial related to infection with HPV
• Current high grade lesions or history of untreated high grade cervical lesion (either CIN2 or CIN3).
• Subject has current or a history of cancer of the cervix.
• Subject has clinically significant (CS) gynaecological abnormalities that could interfere with study evaluation, in the judgment of the Investigator (e.g. prolapse, myoma, fibroid, hysterectomy).
• Subject has a laboratory abnormality Grade ≥ 2, as defined using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials,
• Subject has received any live viral vaccine within 3 months or any other non live vaccine within 2 weeks of first study product administration.
• Subject has primary or secondary systemic immunosuppression
• Subject has a history of severe allergy (requiring hospital care) or history of severe asthma
• Subject has a history of malignant cancer, except the following adequately treated cancers: basal cell carcinoma, or dermatological squamous cell carcinoma.
• Subject was administered with another investigational drug or vaccine within 30 days prior to the screening visit or is participating in any other study.
• Subject has a known hypersensitivity to imiquimod.
• Subject has a history of severe reaction to any drug or vaccination.
• Subject has a medical condition with clinical and/or biological consequences judged by the Investigator incompatible with vaccination(s).
• Subject has positive results for human immunodeficiency virus (HIV), hepatitis B virus (HBV) surface antigen (HBsAg), or hepatitis C virus (HCV).
• Subject has a symptomatic vaginal or genital infection
• Subject has a history of or currently active genital herpes disease.
• Subject is pregnant or is breastfeeding.
• Subject has a positive serum human chorionic gonadotrophin (HCG) result at enrolment.