Cervical Cancer, CIN 2/3
Conditions
Keywords
Therapeutic vaccination
Brief summary
Immune modulating effects and safety of Vvax001; different dosages will be tested in patients with a history of (pre) malignant cervical lesions.
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.
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.
Sponsors
Dutch Cancer Society
ViciniVax B.V
University Medical Center Groningen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of treatment-related adverse events as assessed by CTCAE v4.0 | 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. |
Countries
Netherlands
Outcome results
None listed