Chapter 5. DNA Vaccines: from Research Tools in Mice to Vaccines for Humans

  1. Dr. Oliver Kayser,
  2. Prof. Dr. Rainer H. Müller
  1. Dr. Jeffrey Ulmer1,
  2. Dr. John Donnelly1,
  3. Dr. Jens-Peter Gregersen2

Published Online: 28 JAN 2005

DOI: 10.1002/3527602410.ch5

Pharmaceutical Biotechnology: Drug Discovery and Clinical Applications

Pharmaceutical Biotechnology: Drug Discovery and Clinical Applications

How to Cite

Ulmer, J., Donnelly, J. and Gregersen, J.-P. (2005) DNA Vaccines: from Research Tools in Mice to Vaccines for Humans, in Pharmaceutical Biotechnology: Drug Discovery and Clinical Applications (eds O. Kayser and R. H. Müller), Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim, FRG. doi: 10.1002/3527602410.ch5

Editor Information

  1. Free University Berlin, Institute of Pharmacy, Pharmaceutical Technology, Biopharmacy & Biotechnology, Kelchstr. 31, 12169 Berlin, Germany

Author Information

  1. 1

    Chiron Corporation, 4560 Horton Street, Emeryville, CA 94608-2916, USA

  2. 2

    Chiron-Behring GmbH, Postfach 1630, 35006 Marburg, Germany

Publication History

  1. Published Online: 28 JAN 2005
  2. Published Print: 28 JAN 2004

ISBN Information

Print ISBN: 9783527305544

Online ISBN: 9783527602414

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Keywords:

  • pharmaceutical biotechnology;
  • DNA vaccines;
  • mice;
  • vaccines for humans;
  • immunology;
  • screening for protective antigen candidates;
  • development path;
  • safety;
  • efficacy;
  • pharmacodynamic properties;
  • pharmacokinetic properties;
  • immunotoxicology aspects;
  • registration;
  • licensing

Summary

  • Introduction

  • DNA Vaccine Construction and Immunology

    • DNA Vaccine Expression Plasmids

    • Antigen Presentation and Stimulation of Immune Responses

    • Delivery of DNA Vaccines

  • Screening for Protective Antigen Candidates

  • The Development Path of a DNA Vaccine Candidate

    • Quality of Starting Materials

    • Process Development and In-process Controls

    • Quality of the Final Product

  • Preclinical Safety and Efficacy

    • Pharmacodynamic and Pharmacokinetic Properties of the Vaccine

    • Preclinical Safety and Toxicology Testing

    • Immunotoxicology Aspects

  • Clinical Safety and Efficacy Trials

  • Registration and Licensing of DNA Vaccines

  • Conclusions

  • References