Therapeutic vaccine with objective to clear HPV 16 and 18 genital infections and therefore to prevent cervical pre-cancerous lesions.

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 222

Inclusion Criteria

A subject will be eligible for inclusion in this study if the following criteria apply:
1. Subject is female between the ages of 25 and 50 years (inclusive).
2. Subject is pre-menopausal (referring to the time period preceding menopause, excluding perimenopause) and not on hormone replacement therapy (HRT).
3. Subject must have cervical HPV 16 and/or 18 infection confirmed by Riatol realtime polymerase chain reaction (RT-PCR) assay at baseline. Subject can be co-infected with other HPV serotypes.
4. Subject has a cervical cytological evaluation with a normal, ASCUS or LSIL result at baseline.
5. 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. Highly effective methods of birth control include those that result in a low failure rate (i.e., less than 1% per year) when used
consistently and correctly such as implants, injectable, combined oral contraceptives, Levenorgestrel-releasing intrauterine system, intra-uterine devices (IUDs), vasectomised partner and true sexual abstinence.
6. Subject is in general good health based on medical history and physical examination.
7. Subject is able to communicate effectively with study personnel and is considered reliable, willing, and cooperative in terms of compliance with the protocol requirements.
8. Subject voluntarily gives written informed consent to participate in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 222
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A subject who meets any of the following exclusion criteria must not be enrolled:
1. 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 to ProCervix, in the judgment of the Investigator.
2. Subject has vaginal atrophy with or without topical hormonal therapies or systemic selective estrogen receptor modulators (SERMs).
3. 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 including vaccination with ProCervix.
4. Current high grade lesions or history of untreated high grade cervical lesion (either CIN2 or CIN3).
5. Subject has current or a history of cancer of the cervix.
6. 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 for the following parameters:
- haemoglobin (Hb)
- haematocrit (Hct)
- white blood cell count (WBC)
- lymphocytes
- neutrophils
- eosinophils
- platelet count (plt)
- urea nitrogen (BUN)
- creatinine
- alanine aminotransferase (ALT)
- aspartate aminotransferase (AST)
- alkaline phosphatase (ALP)
- total bilirubin (Tbili)
- prothrombin time (PT)
8. Subject has received any live viral vaccine within 3 months or any other non-live vaccine within 2 weeks prior to screening.
9. Subject has primary or secondary systemic immunosuppression (defined as prolonged [= 7 days] use of corticosteroids that is greater than or equal to 20 mg of prednisone-equivalent per day or any other immunosuppressive drug).
10. Subject has a history of severe allergy (requiring hospital care) or history of severe asthma requiring oral or parenteral drug management in the last year (treatments with inhaled corticosteroids, short-acting beta agonists [SABA], long-acting beta agonists [LABA] or theophylline are allowed).
11. Subject has a history of malignancy, except the following adequately treated cancers: basal cell carcinoma, or dermatological squamous cell carcinoma.
12. Subject was administered with another investigational drug or vaccine within 30 days prior to the screening visit or is participating in any other study.
13. Subject has a known hypersensitivity to imiquimod.
14. Subject has a history of severe reaction to any drug, included kanamcycin, or vaccination.
15. Subject has a medical condition with clinical and/or biological consequences judged by the Investigator incompatible with vaccination(s).
16. Subject has positive results for human immunodeficiency virus (HIV), hepatitis B virus (HBV) surface antigen (HBsAg), or hepatitis C virus (HCV).
17. Subject has a symptomatic vaginal or genital infection (for example, symptomatic candida infection). If appropriate in the judgment of the Investigator, subjects with symptomatic infection may be treated and reconsidered for enrolment after resolution of the symptomatic infection.
18. Subject has a history of or currently active genital herpes disease.
19. Subject is pregnant or is breastfeeding.
20. Subject has a positive serum human chorionic gonadotrophin (HCG) result at enrolment.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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