Safety Study of DNA Vaccine Delivered by Intradermal Electroporation to Treat Colorectal Cancer


NCT01064375

Interventional

Phase 1/Phase 2

Unknown status
El-porCEA
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.
Dec 31,2009
All
18 Years
N/A
20

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