The purpose of this study is to evaluate the safety and immunogenicity of a CEA DNA immunisation approach in patients with colorectal cancer. The DNA plasmid, tetwtCEA, encodes wild type human CEA fused to a tetanus toxoid T helper epitope. The vaccine will be delivered using an intradermal electroporation device, Derma Vax (Cyto Pulse Sciences). The following will be assessed: * The efficiency of priming immunological responses to CEA by intradermal administration of CEA DNA in combination with electroporation. * The efficiency of boosting immunological responses to CEA by intradermal administration of CEA DNA in combination with electroporation in subjects already vaccinated with CEA DNA. * GM-CSF will be administered to half of the subjects primed with CEA DNA in combination with electroporation and any possible adjuvant effects of GM-CSF will be evaluated.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Two vaccinations at week 0 and 12. Intradermal administration of 400ug DNA/dose with electroporation
Electrical pulses applied to vaccination sites in skin using Derma Vax immediately after DNA administration
GM-CSF will be given for 4 consecutive days starting the day before the vaccination as an intradermal/subcutaneous administration of 150 ug of GM-CSF
One intravenous dose of 300 mg/m2 will be given three days before each vaccination with tetwtCEA DNA
Department of Oncology, Karolinska University Hospital
Stockholm, Sweden
To evaluate the safety and immunogenicity of a DNA immunisation approach where tetwtCEA DNA will be administered in combination with electroporation.
Time frame: Within 72 weeks after immunisation
To assess the efficiency of boosting immunological responses to CEA by intradermal administration of tetwtCEA DNA in combination with electroporation in subjects already vaccinated with CEA DNA
Time frame: Within 72 weeks after immunisation
To compare effects (safety and immunogenicity) of additional adjuvance with GM-CSF
Time frame: Within 72 weeks after immunsation
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