Safety Study of DNA Vaccine Delivered by Intradermal Electroporation to Treat Colorectal Cancer
Status:
Unknown status
Trial end date:
2017-10-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Maria Liljefors
Collaborators:
Cyto Pulse Sciences, Inc. Karolinska Institutet Swedish Institute for Infectious Disease Control