A double-blind, randomised, placebo-controlled, Phase II study to evaluate ProCervix efficacy to clear HPV 16 and HPV 18 infection in women with normal cytology or ASCUS/LSI
- Conditions
- Human papilloma virus test positivehuman papillomavirus infectionuterine cervical infection
- Registration Number
- NL-OMON41289
- Lead Sponsor
- Genticel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
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.
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).
7. 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 malignany, except the following adequately treated cancers: basal cell carcinoma, or dermatological squamous cell carcinoma.
12. Subject has a known hypersensitivity to imiquimod.
13. Subject has a history of severe reaction to any drug include kamamycin or vaccination.
14. Subject has a medical condition with clinical and/or biological consequences judged by the Investigator incompatible with vaccination(s).
15. Subject has positive results for human immunodeficiency virus (HIV), hepatitis B virus (HBV) surface antigen (HBsAg), or hepatitis C virus (HCV).
16. 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.
17. Subject has a history of or currently active genital herpes disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary efficacy endpoint:<br /><br>• Clearance at Month 12 of HPV 16 and HPV 18 infection using a type specific,<br /><br>sensitive and quantitative HPV PCR assay. </p><br>
- Secondary Outcome Measures
Name Time Method