This study will assess the feasibility and safety of vaccination with increasing doses of xenogenic DNA administered intradermally in combination with electroporation in patients with relapse of prostate cancer. The DNA encodes prostate specific antigen (PSA) from Rhesus Macaque (Macaca mulatta), a protein that is 89% homologous to human PSA. The study will also assess the safety and functionality of the DERMA VAX™ (Cyto Pulse Sciences) DNA vaccine delivery system.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
5 doses, 4 weeks apart
in vivo electroporation is applied after each DNA injection
Department of Oncology, University Hospital Uppsala
Uppsala, Sweden
Assess the feasibility and safety of escalating doses of pVAXrcPSAv53l DNA vaccine, administered intradermally in combination with electroporation in patients with relapse of prostate cancer.
Time frame: From start of treatment to 30 days (safety) or up to 12 months (immunological & clinical) post last vaccination
Assess the safety and functionality of the DERMA VAX™ in vivo electroporation DNA vaccine delivery system.
Time frame: From start of treatment to 30 days (safety) or up to 12 months (immunological & clinical) post last vaccination
Evaluate the PSA-specific immune response induced by the vaccine.
Time frame: From start of treatment to 30 days (safety) or up to 12 months (immunological & clinical) post last vaccination
Identify an anti-tumor effect of the vaccine.
Time frame: From start of treatment to 30 days (safety) or up to 12 months (immunological & clinical) post last vaccination
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