Current Status of Regulations for DNA Vaccines
DNA vaccines combine the biotechnological manufacturing aspects of a subset of gene therapeutic medicinal products with the mode of action of a classical vaccine. Due to this hybrid state, the regulation of DNA vaccines requires the expertise from both ge
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Bettina Klug, Jens Reinhardt, and James Robertson
DNA vaccines combine the biotechnological manufacturing aspects of a subset of gene therapeutic medicinal products with the mode of action of a classical vaccine. Due to this hybrid state, the regulation of DNA vaccines requires the expertise from both gene therapy and vaccine experts. This chapter will provide an overview of the regulatory status and requirements for DNA vaccines intended for human use. We first introduce the regulatory process in Europe and in the USA and then highlight the most relevant aspects of the already existing guidance documents for DNA vaccines.
Introduction For almost two decades scientists have pursued the development of DNA vaccines, targeting a variety of infectious diseases. DNA vaccines are defined as purified bacterial plasmid preparations containing one or more DNA sequences that express a protein antigen capable of inducing an immune response. Expression plasmids consist in general of an antigen expression cassette and structural elements required for plasmid propagation in bacterial cells. The expression cassette typically contains the gene of interest flanked by a eukaryotic promoter/enhancer and a transcription termination/polyadenylation sequence to promote gene expression in vaccine recipients. To date four DNA medicinal products based upon plasmid DNA have been authorised for veterinary use. Three vaccines, one against West Nile virus in horses, one against infectious haematopoetic necrosis virus in farmed salmon, one for treatment of melanoma in dogs and a growth hormone releasing hormone (GHRH)
B. Klug (*) Paul-Ehrlich Institut, Langen, Germany e-mail: [email protected] J. Thalhamer et al. (eds.), Gene Vaccines, DOI 10.1007/978-3-7091-0439-2_14, © Springer-Verlag/Wien, 2012
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product for foetal loss in swine (Kutzler and Weiner 2008). Detailed information on these veterinary DNA-based vaccines is given in Chap. 13 in this book. To date, no human DNA vaccine has been authorised; however, many are under clinical investigation worldwide, including plasmids expressing malarial, HIV, influenza, tuberculosis (TB) and Ebola virus antigens. Scientists in academia whose research is the backbone of the development of a new vaccine or approach to vaccination may not always be fully aware of the regulatory process by which a successful candidate vaccine becomes an authorised medicinal product. It is useful for research scientists to be aware of these processes as the development of a novel vaccine starts in the research laboratory and an exhaustive amount of data to support a marketing authorisation application is gained from these early studies. This chapter will provide an overview of the regulatory status and requirements for DNA vaccines intended for human use.
The Regulatory Status of DNA Vaccines DNA vaccines combine the biotechnological manufacturing aspects of a subset of gene therapeutic medicinal products with the mode of action of a classical vaccine. Due to this hybrid state, the regulation o
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