Abstract
Scientists in academia whose research is aimed at the development of a novel vaccine or approach to vaccination may not always be fully aware of the regulatory process by which a candidate vaccine becomes a licensed product. It is useful for such scientists to be aware of these processes, as the development of a novel vaccine could be problematic as a result of the starting material often being developed in a research laboratory under ill-defined conditions. This chapter examines the regulatory process with respect to the development of a DNA vaccine. DNA vaccines present unusual safety considerations which must be addressed during nonclinical safety studies, including adverse immunopathology, genotoxicity through integration into a vaccinee’s chromosomes and the potential for the formation of anti-DNA antibodies.
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© 2006 Humana Press Inc.
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Robertson, J.S., Griffiths, E. (2006). Assuring the Quality, Safety, and Efficacy of DNA Vaccines. In: Saltzman, W.M., Shen, H., Brandsma, J.L. (eds) DNA Vaccines. Methods in Molecular Medicine™, vol 127. Humana Press. https://doi.org/10.1385/1-59745-168-1:363
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DOI: https://doi.org/10.1385/1-59745-168-1:363
Publisher Name: Humana Press
Print ISBN: 978-1-58829-484-5
Online ISBN: 978-1-59745-168-0
eBook Packages: Springer Protocols