Vvax001 Cancer Vaccine in (Pre) Malignant Cervical Lesions

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

Detailed Description
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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.

Official Title
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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.

Conditions
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CIN 2/3, Cervical Cancer

Intervention / Treatment
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* Biological: Vvax001 therapeutic cancer vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vvax001 therapeutic cancer vaccine<br>Patients will receive three consecutive doses of Vvax001, with an interval of 3 weeks | Biological: Vvax001 therapeutic cancer vaccine<br>* 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.<br>* Other names: rSFVeE6,7;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Therapeutic vaccination