title: A Phase I safety study of plasmid DNA immunization targeting carcinoembryonic antigen in colorectal cancer patients.
abstract: A plasmid DNA vaccine, encoding a truncated form of human CEA fused to a T-helper epitope (CEA66 DNA) was delivered three times intradermally at 2 mg or intramuscularly at 8 mg by Biojector® to patients with colorectal cancer. Prior to the first vaccination, all patients received cyclophosphamide (300 mg/m²) intravenously. Granulocyte-macrophage colony-stimulating factor (GM-CSF) was administered subcutaneously with each vaccination. All patients completed the vaccine schedule. There were no grade 3 or 4 adverse events (AE). The most frequently reported AE grades 1 and 2 were injection site reactions, fatigue, headache, arthralgia, chest tightness and myalgia. Vaccination with CEA66 DNA in combination with GM-CSF was well tolerated and no signs of autoimmunity have been detected.
authors.affiliation: Department of Oncology and Pathology (Radiumhemmet), Cancer Centre Karolinska, Karolinska Institutet, Karolinska University Hospital Solna, S-17176 Stockholm, Sweden.
authors.forename: Caroline
authors.initials: C
authors.lastname: Staff
authors.forename: Fariba
authors.initials: F
authors.lastname: Mozaffari
authors.forename: B Kristian
authors.initials: BK
authors.lastname: Haller
authors.forename: Britta
authors.initials: B
authors.lastname: Wahren
authors.forename: Maria
authors.initials: M
authors.lastname: Liljefors
mesh_terms: D000368:Aged; D019496:Cancer Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D002272:Carcinoembryonic Antigen / Q000008:administration & dosage* / Q000276:immunology; D015179:Colorectal Neoplasms / Q000276:immunology / Q000628:therapy*; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000276:immunology; D016503:Drug Delivery Systems / Q000295:instrumentation; D004341:Drug Evaluation; D004890:Erythema / Q000139:chemically induced; D005260:Female; D005500:Follow-Up Studies; D058851:GPI-Linked Proteins / Q000008:administration & dosage / Q000276:immunology; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000008:administration & dosage / Q000276:immunology*; D006801:Humans; D007271:Injections, Intradermal; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D010957:Plasmids / Q000276:immunology; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000276:immunology; D014611:Vaccination; D019444:Vaccines, DNA / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology
chemical_list: C527875:CEACAM5 protein, human; D019496:Cancer Vaccines; D002272:Carcinoembryonic Antigen; D058851:GPI-Linked Proteins; D011994:Recombinant Proteins; D019444:Vaccines, DNA; C081222:sargramostim; D016178:Granulocyte-Macrophage Colony-Stimulating Factor; D003520:Cyclophosphamide