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Trial record 7 of 80 for:    "Cervix Disease" | "Vaccines"

Vvax001 Cancer Vaccine in (Pre) Malignant Cervical Lesions

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: NCT03141463
Recruitment Status : Completed
First Posted : May 5, 2017
Last Update Posted : May 3, 2018
Sponsor:
Collaborators:
Dutch Cancer Society
ViciniVax B.V
Information provided by (Responsible Party):
Refika Yigit, University Medical Center Groningen

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

Condition or disease Intervention/treatment Phase
CIN 2/3 Cervical Cancer Biological: Vvax001 therapeutic cancer vaccine Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : January 13, 2017
Actual Primary Completion Date : November 28, 2017
Actual Study Completion Date : November 28, 2017

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 Name: rSFVeE6,7




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03141463


Locations
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Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9700 RB
Sponsors and Collaborators
University Medical Center Groningen
Dutch Cancer Society
ViciniVax B.V
Investigators
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Principal Investigator: R Yigit, MD PhD University Medical Center Groningen

Publications:
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Responsible Party: Refika Yigit, MD PhD, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT03141463     History of Changes
Other Study ID Numbers: Vvax001-UMCG-01
2015-004979-74 ( EudraCT Number )
NL56680.000.16 ( Other Identifier: CCMO )
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Refika Yigit, University Medical Center Groningen:
Therapeutic vaccination
Additional relevant MeSH terms:
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Uterine Cervical Diseases
Vaccines
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Immunologic Factors
Physiological Effects of Drugs