New Approaches to Stabilisation of Vaccines Potency: Who Headquarters, May 1995

Author: Fred Brown
Published: July 1996
Publisher: Karger, S. Inc.
ISBN: 3805563094
Paperback Book
Number of Pages: 364

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Immunization is one of the most important tools in public health and, according to the World Bank, the most cost-effective intervention in medicine. Vaccines have to be developed, field-tested, licensed, produced, quality controlled, regulated, purchased, transported, stored and delivered. Vaccine stability is a crucial factor to ensure that the vaccine delivered to the child is safe and effective. This book reports the proceedings of an international conference organized by the International Association of Biological Standardization and representatives of WHO's Global Programme for Vaccines and Immunization to discuss technical and regulatory aspects of vaccine stability and ways to improve collaboration. Topics under consideration include vaccine transport and storage; problems with maintaining the cold chain, especially in developing countries; reasons for instability of existing vaccines, and recent developments in the design of viral, bacterial and parasite vaccines. The factors affecting vaccine stability are evaluated, and a large number of new approaches for vaccine stabilisation are presented. Comprehensive and up-to-date, this publication will be appreciated by anyone concerned with the development, production and distribution of vaccines.

Table of Contents:

Keynote Address 1
Current Requirements and Strategies for Vaccine Stabilisation 7
Vaccine Transport and Storage: Environmental Challenges 9
Vaccine Stability in the Context of Vaccine Delivery in a Developing Country: India 19
Problems Encountered in the Delivery and Storage of OPV in an African Country 27
Experience with Veterinary Vaccines in Warm Climates 33
Will Stability Remain an Issue for 21st Century Vaccines? 43
Research Priorities for the WHO Global Programme for Vaccines and Immunization 45
Recent Developments in the Design of Viral Vaccines 51
Recent Trends in the Developments of Bacterial Vaccines 59
Progress on Vaccines Against Parasites 73
Developments in Immunization Practices and Strategies: Implications for Vaccine Stability 85
Reasons for Instability of Existing Vaccines 95
Factors Affecting the Stability of Viral Vaccines 97
Stabilising Oral Poliovaccine at High Ambient Temperatures 103
Reasons for Instability of Bacterial Vaccines 113
The Reaction of Bacterial Toxins with Formaldehyde and its Use for Antigen Stabilization 125
Analysis of Vaccine Stability 135
Physicochemical Studies of the Structure and Stability of Polysaccharide-Protein Conjugate Vaccines 143
New Approaches to Vaccine Stabilisation (1) 153
Thermostability of Poliovirus and Measles Vaccines 155
The Replacement of Water with Deuterium Oxide Significantly Improves the Thermal Stability of the Oral Poliovirus Vaccine 161
A Varicella Vaccine Stable at 5[degree]C 167
Stabilisation of Poliovirus with Pirodavir 173
Regulatory Considerations for New Stabilised Poliovaccines 181
New Approaches to Vaccine Stabilisation (2) 191
Stabilisation of Vaccines Using Trehalose (Q-T4) Technology 193
Potential of Chimaeric Plant Virus Particles as Novel, Stable Vaccines 201
Protein Stabilisation Using Additives Based on Multiple Electrostatic Interactions 207
Stability of Yellow Fever Vaccine 219
Poster Session 227
Vaccine Stability not by Eliminating Thermolability but through the Environmental Stability 229
Biodegradable Microparticles as Parenteral Vaccine Delivery Systems 231
New Approaches to Vaccine Stabilisation (3) 233
Stabilization of Rinderpest Vaccine by Modification of the Lyophilization Process 235
Stability of Recombinant Vaccinia-Rabies Vaccine in Veterinary Use 245
Stabilisation of BCG Vaccines 251
Stability Testing in Haemophilus Influenzae Type b Conjugate Vaccines 263
Glycoconjugate Vaccines: Future Combinations 269
Factors Influencing the Stability of Live Oral Attenuated Bacterial Vaccines 277
Mimicry of Viral Epitopes with Retro-Inverso Peptides of Increased Stability 283
Strategies for Stabilizing Tetanus Toxoid towards the Development of a Single-Dose Tetanus Vaccine 293
Standardization of Vaccine Stability: Regulatory Issues 307
Stability Testing Requirements for Vaccines - Draft Guidelines of the International Conference on Harmonization (ICH) 309
Regulatory Requirements for Veterinary Vaccine Stability in the European Community 319
Regulatory Practices and Problems with Vaccine Stability Studies and the Establishment of Shelf Lives 329
General Discussion 335
Summary and Conclusions 337

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