Chapter category: Vaccines
Clinical Issues for New Vaccine Technologies
New Vaccine Technologies
Edited by: Ronald W. EllisISBN: 1-58706-050-7
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Chapter authors:
Luc Hessel
Vaccination as a means of preventing infectious diseases arguably has had the greatest impact on human health of any medical intervention.1 Since the pioneer work of Jenner and Pasteur, the development of vaccines has been the consequence of the uninterrupted introduction of a series of new technologies. The discovery of toxoids, purification of polysaccharides, cell culture enabling virus culture, controlled methods for attenuation of viruses, conjugation of polysaccharides to proteins, production of protein vaccines in genetically-engineered cells and reassortment of viruses have been among the basic technologies used so far in the development of vaccines.1,2 Application of the tools of modern biotechnology has resulted in an array of vaccine candidates coming from many sources and created the promise of prevention or treatment for many more infectious and chronic diseases.3,4 It has also revolutionized the capability to engineer and produce vaccines that are potentially safer, more effective, easier to produce and less costly.5 The forthcoming new technologies form a continuum in the innovative process that has always been characteristic of vaccine development. Different new technologies are currently considered with more attention, such as
- genetically-engineered vaccines,
- live vectors,
- nucleic acid vaccines,
- new delivery systems or
- new adjuvants.1,2
This biotechnology revolution poses a tremendous challenge for traditional vaccine development to provide adequate and timely assessments so that maximal benefits might be reaped from these advances.6 Indeed, successful development of vaccines is a time-intensive process requiring years of commitment from a network of scientists and a continuum of regulatory and manufacturing entities.7
The vaccine development process leading to licensure is pyramidal and selective.4 It is step-wise and bridges basic research, development, large-scale production in an approved facility, and clinical evaluation to establish safety and protective efficacy.7 Although not basically different than for conventional vaccines, the clinical contribution to the development of new vaccines is of special importance at many stages of the discovery process and can be schematically defined as follows:
- definition of the medical needs,
- choice of the rationale and elaboration of the strategy based on preclinical development,
- demonstration of proof-of-principle in early clinical research,
- design and implementation of an integrated clinical development plan and
- continuous assessment of safety and efficacy.
Additional chapters from this book:
Transcutaneous Immunization
Gregory M. Glenn
The skin is a highly complex yet well-orchestrated system committed to its protective barrier function. Human integument not only keeps moisture in and foreign material out, but is also des...
Biological Aspects and Prospects for Adjuvants and Delivery Systems
Bror Morein and Ke-Fei Hu
There is no all-encompassing definition for an adjuvant, but an old definition is: a substance that enhances the immunogenicity of coadministered antigens without !=inducing an immune response...
Plant-Derived Vaccines
Amanda M. Walmsely and Charles J. Arntzen
Vaccination has traveled a long road since the contents of smallpox pustules were used to inoculate individuals.1 Whilst vaccines consisting of attenuated or inactivated whole or...
DNA Vaccines
Daniel E. McCallus, Catherine J. Pachuk, Shaw-guang Lee and C. Satishchandran
Research into the use of DNA vaccines has shown that this mode of immunization has much potential for widescale application. The ability to elicit an immune response by injection of DNA enc...
Polysaccharide Vaccines
Stephen Freese
The immune response to polysaccharide antigens is qualitatively different from that to protein antigens. Considering only those aspects that bear upon immunity to polysac- charides, the dif...
Peptide Vaccines
Damu Yang, Gregory E. Holt, Michael P. Rudolf, Markwin P. Velders, Remco M. P. Brandt, Eugene D. Kwon, and W. Martin Kast
For most of the history of vaccine production, the development of a new vaccine involved producing inactivated organisms or crude components of the pathogen. There is now generally a need to d...
Protein-Based Vaccines
Sheena M. Loosmore, Gavin R. Zealey, and Raafat E.F. Fahim
The introduction of inactivated vaccines for viral or bacterial diseases such as smallpox, polio, pertussis, tuberculosis, measles, mumps and rubella has led to the eradication or control of t...
Live Attenuated Bacterial Vectors
Sims K. Kochi and Kevin P. Killeen
It is doubtful that Louis Pasteur could have anticipated the significance in 1881 that his discovery of bacterial attenuation would have on the use of microorganisms to protect against infe...
Live Attenuated Bacterial Vaccines
Kevin P. Killeen and Victor J. DiRita
Immunization is the most effective public health tool used to control infectious disease. Moreover, it is extremely cost effective given that treatment of disease is far more expensive than...
Inactivated Virus Vaccines
Andrew D. Murdin, Benjamin Rovinski, Suryaprakash Sambhara
Inactivated virus vaccines have made a significant contribution to the control of infectious disease during the 20th century and will surely remain an important feature of vaccin...
Live Viral Vectors
Elizabeth B. Kauffman, Michel Bublot, Russell R. Gettig, Keith J. Limbach, Steven E Pincus, and Jill Taylor
Live viral vector vaccines derived by the insertion of genes encoding sequences from disease organisms offer a number of advantages over live attenuated vaccines, inactivated vaccines, subu...
Recombinant Live Attenuated Viral Vaccines
Richard R. Spaete
Vaccination with live attenuated viruses in general offers a number of advantages as a strategy to evoke an effective and long lasting immune response. Foremost among these is the possibili...
Live Vaccines
Alan R. Shaw
Live attenuated viral vaccines represent the most effective means of inducing a broad immune response against viruses that can be cultivated in vitro. These vaccines mimic a natural ...
In-Licensing Issues and Vaccine Technologies
Dale R. Spriggs
The pharmaceutical industry is undergoing profound changes as the advances in biotechnology give rise to new technologies and approaches to discovering and developing new products. Conventi...
Vaccine Regulatory Issues
Marion F. Gruber, Paul G. Richman and Julianne C. M. Clifford
The fundamental goals in developing new vaccine technologies are to improve current vaccines for existing clinical indications and to develop new immunogens for both pediatric and adult use...
Clinical Issues for New Vaccine Technologies
Luc Hessel
Vaccination as a means of preventing infectious diseases arguably has had the greatest impact on human health of any medical intervention.1 Since the pioneer work of Jenner and P...
New Technologies for Making Vaccines
Ronald W. Ellis
The past two decades have witnessed an explosion in the number of technological and immunological approaches for making new vaccines. These developments have flowed from advances in a broad...
