alexa A Phase I safety study of plasmid DNA immunization targeting carcinoembryonic antigen in colorectal cancer patients.
Immunology

Immunology

Journal of Clinical & Cellular Immunology

Author(s): Staff C, Mozaffari F, Haller BK, Wahren B, Liljefors M

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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. Copyright © 2010 Elsevier Ltd. All rights reserved. This article was published in Vaccine and referenced in Journal of Clinical & Cellular Immunology

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