• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • Patient Education
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Genticel to continue per protocol its phase II study with ProCervix after review by DSMB

Genticel to continue per protocol its phase II study with ProCervix after review by DSMB

January 29, 2015
CenterWatch Staff

Genticel, a French biotechnology company and developer of therapeutic vaccines, has announced that the Data and Safety Monitoring Board (DSMB), an independent committee of experts which monitors safety data every six months during a study, met as scheduled on Jan. 22. It recommended the RHEIA-VAC study proceed without any modifications. The DSMB already had made the same recommendation during the first review on July 1, 2014.

RHEIA-VAC (Research on HPV Eradication In Adults by VACcination) is a double-blinded, randomized, placebo-controlled phase II efficacy study of the ProCervix therapeutic vaccine. ProCervix is used for HPV 16 and/or 18 infected women, who have normal cervical cytology or ASCUS/LSIL (mild cervical cellular dyskaryosis). The absolute risk of these women developing high grade lesions within four years is about 34%, i.e. approximately one in three persons.

On Nov. 13, 2014, Genticel announced achieving the full enrollment of all 239 patients in the study more than four months ahead of schedule and retaining 99% of participating subjects in the trial. As a reminder, the primary endpoint of this phase II trial, viral clearance, is set 12 months after first vaccination. With patient enrollment completed sooner than anticipated, Genticel should be able to communicate on this primary endpoint, by treatment group, during the first half of 2016 rather than in the second, as was initially planned.

Dr. Sophie Olivier, chief medical officer at Genticel, said, “We are very satisfied with the progress of the RHEIA-VAC study and with the continuing commitment of all our investigators, whose motivation has been a cornerstone in the recruitment and retention of women in this trial.” She added, “It also is reassuring that the DSMB, which has now evaluated safety, tolerance and compliance data on almost all patients enrolled in this clinical study, has again allowed the trial to pursue per protocol.”

Upcoming Events

  • 11Feb

    Lab X.0: Addressing Quality and Compliance Challenges in Laboratory Operations in the COVID-19 All-Digital Era

  • 23Mar

    Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges

  • 26Apr

    MAGI's Clinical Research vConference — Spring 2021

Featured Products

  • Regenerative Medicine – Steps to Accelerate Development : PDF

    Regenerative Medicine: Steps to Accelerate Development

  • Clinical Trial Agreements — A Guide to Key Words and Phrases : PDF

    Clinical Trial Agreements: A Guide to Key Words and Phrases

Featured Stories

  • Resources-360x240.png

    Trial Complexity, Endpoints Continue to Increase, Stretching Site Resources

  • FocusinRed-360x240.png

    Return to Focus on Risk Management Postpandemic Could Prove Challenging to Sites

  • VaccinewithNeedle-360x240.png

    2021 Vaccine Industry Will Continue to be Dominated by COVID-19 Trials, Experts Say

  • Dominate-360x240.png

    COVID-19, Oncology, CNS and Infectious Disease Trials Will Dominate in 2021, Survey Predicts

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell My Personal Information

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing