Clinical trial · Interventional
Vvax001 Cancer Vaccine in (Pre) Malignant Cervical Lesions
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.
NCT03141463CI-TRIAL-00032758completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Immune modulating effects and safety of Vvax001; different dosages will be tested in patients with a history of (pre) malignant cervical lesions.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| CIN 2/3 | Cervical Intraepithelial Neoplasia Grade 2/3 | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vvax001 therapeutic cancer vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vvax001 therapeutic cancer vaccine
- description
- Patients will receive three consecutive doses of Vvax001, with an interval of 3 weeks
- interventionNames
- Biological: Vvax001 therapeutic cancer vaccine
Primary outcomes (1)
- measure
- Immunogenicity
- timeFrame
- Day 28-31 and day 49-52 after first administration of Vvax001
- description
- To assess the immunological activity of Vvax001 by monitoring HPV-16 E6,7-specific T-cell immune responses
Secondary outcomes (1)
- measure
- Number of treatment-related adverse events as assessed by CTCAE v4.0
- timeFrame
- up to 49-52 days after first administration of Vvax001
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDDaemen 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. PMID 15535411
- BACKGROUNDRiezebos-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. PMID 17928874
- BACKGROUNDDraghiciu 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. PMID 26451295