Vvax001 Cancer Vaccine in (Pre) Malignant Cervical Lesions

May 2, 2018 updated by: Refika Yigit, University Medical Center Groningen

Immune Modulating Effects and Safety of Vvax001, a Therapeutic Semliki Forest Virus Based Cancer Vaccine, in Patients With a History of (Pre) Malignant Cervical Lesions.

Immune modulating effects and safety of Vvax001; different dosages will be tested in patients with a history of (pre) malignant cervical lesions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Vvax001 is a therapeutic cancer vaccine consisting of a replication-incompetent Semliki Forest Virus (SFV) vector encoding HPV-derived tumor antigens. Patients will receive three consecutive doses, with an interval of 3 weeks.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9700 RB
        • University Medical Center Groningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • A history of CIN II and III OR cervical cancer
  • Minimally 12 weeks after completion of treatment
  • Age of 18 years and older
  • Baseline laboratory findings; adequate hepatic, renal ,and bone marrow function, HIV- and HBV-negative
  • Patients of child-bearing potential should test negative using a serum pregnancy test and agree to utilize effective contraception during the entire treatment and follow-up period of the study
  • Written informed consent according to local guidelines

Exclusion Criteria:

  • Prior treatment with immunotherapeutic agents against HPV
  • History of an autoimmune disease or other systemic intercurrent disease that might affect the immunocompetence of the patient, or current or prior use (4 weeks before start of the study) of high dose immunosuppressive therapy.
  • History of a second malignancy except curatively treated low-stage tumors with a histology that can be differentiated from the cervical cancer type
  • Participation in a study with another investigational drug within 30 days prior to the enrolment in this study
  • Any condition that in the opinion of the investigator could interfere with the conduct of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vvax001 therapeutic cancer vaccine
Patients will receive three consecutive doses of Vvax001, with an interval of 3 weeks
Biological: Vvax001 therapeutic cancer vaccine
Vvax001 is a vaccine consisting of a replication-incompetent Semliki Forest Virus (SFV) vector encoding HPV-derived tumor antigens. Patients will receive three consecutive doses, with an interval of 3 weeks.
Other Names:
  • rSFVeE6,7

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunogenicity
Time Frame: Day 28-31 and day 49-52 after first administration of Vvax001
To assess the immunological activity of Vvax001 by monitoring HPV-16 E6,7-specific T-cell immune responses
Day 28-31 and day 49-52 after first administration of Vvax001

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: up to 49-52 days after first administration of Vvax001
To monitor the side effects/ adverse events related to intramuscular administration of Vvax001. Toxicity will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
up to 49-52 days after first administration of Vvax001

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Collaborators

Dutch Cancer Society
ViciniVax B.V

Investigators

  • Principal Investigator: R Yigit, MD PhD, University Medical Center Groningen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2017

Primary Completion (Actual)

November 28, 2017

Study Completion (Actual)

November 28, 2017

Study Registration Dates

First Submitted

March 16, 2017

First Submitted That Met QC Criteria

May 2, 2017

First Posted (Actual)

May 5, 2017

Study Record Updates

Last Update Posted (Actual)

May 3, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vvax001-UMCG-01
  • 2015-004979-74 (EudraCT Number)
  • NL56680.000.16 (Other Identifier: CCMO)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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