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Phase II Study of HPV Therapeutic Vaccine in HPV Infected Women With Normal Cytology or ASCUS/LSIL (RHEIA-VAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01957878
Recruitment Status : Completed
First Posted : October 8, 2013
Last Update Posted : December 2, 2016
Sponsor:
Information provided by (Responsible Party):
Genticel

Tracking Information
First Submitted Date  ICMJE October 4, 2013
First Posted Date  ICMJE October 8, 2013
Last Update Posted Date December 2, 2016
Study Start Date  ICMJE December 2013
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2013)
Clearance of HPV 16 and HPV 18 infection at Month 12 using a type specific, sensitive and quantitative HPV PCR assay. [ Time Frame: month 12 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 7, 2013)
• Clearance at Month 12 of HPV 16 and HPV 18 infection using a type specific, sensitive and quantitative HPV PCR assay. [ Time Frame: month 12 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2013)
Clearance of HPV 16 and HPV 18 infection. [ Time Frame: Month 6, 15, 18, 24 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2013)
• Clearance at Month 6, 15, 18 and 24 of HPV 16 and HPV 18 infection. [ Time Frame: Month 24 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Study of HPV Therapeutic Vaccine in HPV Infected Women With Normal Cytology or ASCUS/LSIL
Official Title  ICMJE 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/LSIL
Brief Summary

Human Papillomavirus (HPV) 16 and HPV 18 (the two virus genotypes targeted by the ProCervix vaccine) are the most common HPV genotypes associated with at least 70% of squamous cell carcinomas and 82% of adenocarcinomas of the cervix The strategy of therapeutic vaccination with ProCervix is to activate and enhance the patient's cellular immune response to HPV . The therapeutic vaccine will be used for women infected by HPV 16, HPV 18, or both. The vaccine targets these HPV infected women with normal or mild cervical cellular dyskaryosis as detectable infections with oncogenic potential.

This will be a double-blind, randomised, placebo-controlled, parallel group study assessing the efficacy of ProCervix or placebo (concomitantly administered with imiquimod cream).

ProCervix will be delivered with a topical agent, imiquimod, applied to the injection sites as a vaccine adjuvant.

The population proposed for this study represents an otherwise healthy female population who are infected with HPV 16 and/or HPV 18. The safety and tolerability of this therapeutic vaccine has been shown in the ongoing Phase I study, and the proposed population may in theory derive benefit from this vaccine.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Genital Infection Viral
  • HUMAN PAPILLOMA VIRUS
Intervention  ICMJE
  • Biological: ProCervix
    ProCervix consists of two recombinant adenylate cyclase (CyaA) proteins, CyaA-HPV 16E7 (C16-1) and CyaA-HPV 18E7 (C18-1) in a 50/50 ratio (C16C18-2 Ag mixture). ProCervix is adjuvanted by Aldara™, a cream containing 5% of imiquimod
  • Biological: Placebo
    Placebo matching ProCervix and adjuvanted by Aldara™, a cream containing 5% of imiquimod
Study Arms  ICMJE
  • Experimental: HPV therapeutic vaccine
    ProCervix consists of two recombinant adenylate cyclase (CyaA) proteins, CyaA-HPV 16E7 (C16-1) and CyaA-HPV 18E7 (C18-1) in a 50/50 ratio (C16C18-2 Ag mixture). ProCervix is adjuvanted by Aldara™, a cream containing 5% of imiquimod
    Intervention: Biological: ProCervix
  • Placebo Comparator: Placebo matching ProCervix
    Placebo matching ProCervix and adjuvanted by Aldara™, a cream containing 5% of imiquimod
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 1, 2016)
239
Original Estimated Enrollment  ICMJE
 (submitted: October 7, 2013)
220
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 .
    3. Subject must have cervical HPV 16 and/or 18 infection confirmed by RT-PCR
    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. .
    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.

Exclusion Criteria:

  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
  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
  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,
  8. Subject has received any live viral vaccine within 3 months or any other non live vaccine within 2 weeks of first study product administration.
  9. Subject has primary or secondary systemic immunosuppression
  10. Subject has a history of severe allergy (requiring hospital care) or history of severe asthma
  11. Subject has a history of malignant cancer, 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 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
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 25 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Finland,   France,   Germany,   Netherlands,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01957878
Other Study ID Numbers  ICMJE PC10VAC02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genticel
Study Sponsor  ICMJE Genticel
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Genticel
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP