Immune modulating effects and safety of Vvax001; different dosages will be tested in patients with a history of (pre) malignant cervical lesions.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
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.
University Medical Center Groningen
Groningen, Netherlands
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
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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