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CompletedNCT03141463Updated May 3, 2018

Vvax001 Cancer Vaccine in (Pre) Malignant Cervical Lesions

A Phase 1 interventional study of Vvax001 therapeutic cancer vaccine in CIN 2/3 and Cervical Cancer, sponsored by University Medical Center Groningen. Completed at 1 site in Netherlands. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-03.

Sponsored by University Medical Center Groningen · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
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Study summary

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

Read the 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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Conditions studied

  • CIN 2/3
  • Cervical Cancer

Keywords

  • Therapeutic vaccination
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In context

Uterine Cervical Neoplasms

1,879 studies on the registry are indexed under Uterine Cervical Neoplasms; 565 are open to participants now.

This study's enrollment of 12 is below the median of 100 across 1,375 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

University Medical Center Groningen is the lead sponsor of 609 studies on the registry; 174 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Vvax001 therapeutic cancer vaccine

    Patients will receive three consecutive doses of Vvax001, with an interval of 3 weeks

    Biological: Vvax001 therapeutic cancer vaccine

Interventions

  • BiologicalVvax001 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.

    Also known as: rSFVeE6,7

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What researchers measure

Primary outcomes

  1. Immunogenicity

    To assess the immunological activity of Vvax001 by monitoring HPV-16 E6,7-specific T-cell immune responses

    Time frame: Day 28-31 and day 49-52 after first administration of Vvax001

Secondary outcomes

  1. Number of treatment-related adverse events as assessed by CTCAE v4.0

    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.

    Time frame: up to 49-52 days after first administration of Vvax001

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Study locations

1 site
  • University Medical Center Groningen
    Groningen, 9700 RB, Netherlands
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References and documents

Publications

  • Daemen T, Riezebos-Brilman A, Regts J, Dontje B, van der Zee A, Wilschut J. Superior therapeutic efficacy of alphavirus-mediated immunization against human papilloma virus type 16 antigens in a murine tumour model: effects of the route of immunization. Antivir Ther. 2004 Oct;9(5):733-42. PubMed 15535411 ↗
  • Riezebos-Brilman A, Walczak M, Regts J, Rots MG, Kamps G, Dontje B, Haisma HY, Wilschut J, Daemen T. A comparative study on the immunotherapeutic efficacy of recombinant Semliki Forest virus and adenovirus vector systems in a murine model for cervical cancer. Gene Ther. 2007 Dec;14(24):1695-704. doi: 10.1038/sj.gt.3303036. Epub 2007 Oct 11. PubMed 17928874 ↗
  • Draghiciu O, Boerma A, Hoogeboom BN, Nijman HW, Daemen T. A rationally designed combined treatment with an alphavirus-based cancer vaccine, sunitinib and low-dose tumor irradiation completely blocks tumor development. Oncoimmunology. 2015 May 27;4(10):e1029699. doi: 10.1080/2162402X.2015.1029699. eCollection 2015 Oct. PubMed 26451295 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03141463
Lead sponsor
University Medical Center Groningen
Collaborators
Dutch Cancer Society, ViciniVax B.V
Responsible party
Refika Yigit (MD PhD, University Medical Center Groningen) — Principal investigator
First posted
May 5, 2017
Start date
Jan 13, 2017
Primary completion
Nov 28, 2017
Completion
Nov 28, 2017
Last update
May 3, 2018

Study contacts

R Yigit, MD PhD
principal investigator · University Medical Center Groningen

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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