Tables of Contents for Veterinary Vaccinology

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Chapter/Section Title

Page #

Page Count

Foreword

List of editors and authors

xxi

Introduction

xxv

I. HISTORY

Chapter 1. Historical Introduction

F. Fenner

P. -P. Pastoret

J. Blancou

J. Terre

Part 1. Early studies on immunisation

1.1. Jenner, smallpox and cowpox

1.2. Louis Pasteur and the birth of vaccinology

1.3. Immunisation with inactivated bacteria

1.4. Immunisation with soluble proteins: toxins, antitoxins and toxoids

Part 2. The immunological basis of immunisation

2.1. Cellular aspects of immunity: phagocytosis

2.2. The production of antibodies

2.3. Delayed hypersensitivity, allograft rejection and the concept of cell-mediated immunity

2.4. Sites of antibody production

2.5. The immunological function of the thymus

2.6. MHC restriction

Part 3. The pathogenesis of infectious diseases

3.1. Lymphocyte trafficking

3.2. Routes of infection and spread

Part 4. Large-scale cultivation of viruses

Part 5. Regulation and licensing

Part 6. Future possibilities

References

II. BIOLOGY OF VACCINATION

146

Chapter 2. Antigens

M. Van Regenmortel

R. L. Tellam

C. Manteca

J. Mainil

P. -P. Pastoret

Part 1. Antigenicity and immunogenicity

Part 2. Structure of viruses and viral antigens

2.1. Picornaviruses

2.2. Influenza viruses

2.3. Structural and non-structural antigens

2.4. Antigenic molecular cooperation

2.5. Viral superantigens

2.6. Virokines and viroceptors

2.7. Virus antigenic variation

2.8. Essential and non-essential viral proteins

2.9. Group-specific and type-specific antigens

2.10. Recombination, reassortment, reversion

Part 3. Structure of bacterial antigens

3.1. Bacterial virulence

3.2. Classical antigens of the bacterial cell

3.3. Specific virulence factors

3.4. Antigenic variation

Part 4. Structure of parasitic antigen

4.1. Antigens with repeated blocks of sequences

4.2. Polymorphic antigens

4.3. Antigen variation

4.4. Co-expressed related antigens

4.5. Antigens shed from the parasite surface

4.6. Excretory and secretory (E/S) antigens

4.7. Antigens with defined biochemical functions

4.8. General comments on antigen structure

Part 5. Conclusion

References

Chapter 3. The Immune Response

G. F. Rimmelzwaan

A. D. M. E. Osterhaus

Part 1. Antigen presentation

Part 2. Antigen competition

Part 3. Kinetics of humoral and cellular immune responses

Part 4. Regulation of immune responses

Part 5. Immunological memory and booster effect

Part 6. Systemic, local and colostral immunity

Part 7. Passive immunity

References

Chapter 4. In Vitro Methods in Vaccinology

K. C. McCullough

C. F. M. Hendriksen

T. Seebeck

Part 1. Introduction

Part 2. Recent developments in vaccine control

Part 3. Overview of current approach to alternative methods

Part 4. Future potentials

4.1. Importance of the immune response

4.2. Limitations of animal models

4.3. Potential for in vitro studies of the immune response

Part 5. Essential parameters for any in vitro test system to study immune responses

5.1. Maintenance of viability in the immune system

5.2. The inductive phase of the immune response

5.3. The effector phase

5.4. Immunological memory

5.5. Conclusions on essential parameters for the in vitro immune response

Part 6. Construction of in vitro systems to analyse the immune response

6.1. Cell preparation

6.2. Cell concentrations

6.3. Sources of cells: lymphoid organs or blood?

6.4. Primary or secondary immune responses?

6.5. Conclusions on construction of in vitro systems

Part 7. Potential of antibody repertoire cloning in vaccinology

7.1. The concept of repertoire cloning

7.2. The biology of repertoire cloning

7.3. Selection of the few from the many

7.4. Production of pure soluble FAB fragments

7.5. Antibody engineering

7.6. Naive libraries versus antibodies generated by mutagenesis

7.7. Random peptide phage libraries

7.8. Antibody- and peptide-phages: prospects for vaccine development

Part 8. Studies on vaccine efficacy in vitro/ex vivo

8.1. In vitro analyses (primary in vitro immune response)

8.2. Ex vivo analyses of induced antibody (detection of antibody produced by the in vivo immune response)

8.3. Ex vivo analyses of lymphocyte induction (secondary in vitro immune response) measured through antibody production

8.4. Ex vivo analyses of lymphocyte induction (secondary in vitro immune response) measured through cytokine production

101

8.5. Ex vivo analyses of lymphocyte induction (secondary in vitro immune response) measured through cellular proliferation

102

8.6. Choosing the antigen for ex vivo analyses

103

Part 9. Conclusions

104

References

105

Chapter 5. Epidemiology of Infections and Parasitic Infestations

113

M. Eloit

J. -J. Benet

P. Bourdeau

Part 1. Introduction

114

Part 2. Quantification of health status in a population

114

2.1. Use of indicators

114

2.2. Epidemiological description

115

2.3. Methods for comparison of populations

116

Part 3. Survival and propagation of pathogens

117

3.1. Basic concepts

117

3.2. Epidemic process

123

Part 4. Contribution of epidemiology to the design of vaccination strategy

128

References

129

Chapter 6. General Description of Vaccines

131

M. C. Horzinek

V. E. C. J. Schijns

M. Denis

P. Desmettre

L. A. Babiuk

Part 1. Definition and diversity

132

Part 2. Categories of vaccines

132

2.1. Killed vaccines

132

2.2. Live vaccines

133

2.3. Future vaccines

134

Part 3. Applications of vaccines

135

Part 4. Vaccine combinations

137

Part 5. Autogenous vaccines

137

5.1. Tumour immunology and autovaccination

138

5.2. Crude autogenous vaccines

138

5.3. New developments

139

Part 6. Adjuvants and vehicles

140

6.1. Classification of adjuvants

141

6.2. Mineral compounds

142

6.3. Oil emulsions

142

6.4. Bacterial products

143

6.5. Liposomes

144

6.6. Saponins and ISCOMS

145

6.7. Biodegradable microparticles

145

Part 7. The use of cytokines

147

References to Parts 1-7

148

Part 8. Specifications of vaccines for developing countries

153

G. Uilenberg

T. T. Dolan

8.1. Major epizootic infectious diseases

153

8.2. Strictly tropical diseases

153

References to Part 8

157

Chapter 7. Properties of Vaccines

159

J. -P. Soulebot

C. Folkers

J. Taylor

P. -P. Pastoret

Part 1. Criteria for the choice of a vaccine strain

160

Part 2. Demonstration of safety for target and non-target animal species (including man)

161

Part 3. Demonstration of efficacy

162

Part 4. Duration of efficacy

163

Part 5. Potency testing

164

Part 6. Field trials

165

Part 7. Evaluation of (pharmaceutical) quality aspects

165

III. LIFE OF A VACCINE

169

Chapter 8. Introduction

169

B. Tolud

Part 1. The first decision: to develop or not to develop a vaccine?

170

Part 2. The role of government policies in the development of veterinary vaccines

170

Part 3. Decision factors in the development of a veterinary vaccine

171

Part 4. Structure of the industry, competition and price-cycle of veterinary vaccines

173

Chapter 9. Research and Development

175

Ph. Desmettre

S. Martinod

Part 1. Conception of a vaccine

176

1.1. Documentary phase

176

1.2. Feasibility phase

176

1.3. Pre-development phase

177

Part 2. Development

178

Part 3. Inactivation process

179

Part 4. Experimental evaluation of efficacy (mono- and multivalent vaccines)

181

4.1. Monovalent vaccines

181

4.2. Multivalent vaccines

182

Part 5. Challenge

182

Part 6. Evaluation of genetic stability

183

6.1. Reversion to virulence

184

6.2. Recombination or genomic reassortment of strains

184

6.3. Safety in non target species

185

Part 7. Experimental evaluation of safety

185

7.1. Safety of the administration of one dose

185

7.2. Safety of one administration of an overdose

185

7.3. Safety of the repeated administration of one dose

186

7.4. Examination of immunological function

186

Part 8. Demonstration of absence of transmission and/or carrier state

186

Part 9. Demonstration of safety in pregnant animals

187

Part 10. Field trials

188

Part 11. Evaluation of epidemiological implications of vaccination

190

Part 12. Biases in the evaluation process

191

12.1. Influence related to the experimentation subjects

191

12.2. Influences related to the conditions of evaluation

191

Part 13. Formulation

192

13.1. Live vaccines

192

13.2. Inactivated or subunit vaccines

192

References

193

Chapter 10. Manufacture and Controls

195

Part 1. Production process and premises

196

P. Luff

J. -P. Soulebot

1.1. Need

196

1.2. Practicality

197

Part 2. Types and evolution of production processes

197

P. Luff

J. -P. Soulebot

2.1. Substrate

198

2.2. Yield increase

198

2.3. Antigen purity

199

2.4. Convergence of culture systems

200

Part 3. Good manufacturing practices

201

P. Luff

J. -P. Soulebot

3.1. Immediate background

201

3.2. Scope of the requirements

201

3.3. Structure of the guide

201

3.4. Purpose of GMP

202

Part 4. Production and biosafety

202

P. Luff

J. -P. Soulebot

4.1. Scope

202

4.2. GMP and biosafety

203

Part 5. Physico-chemical conformity analysis

205

R. Lucken

R. Stolp

5.1. Tests for residual substances

205

5.2. Tests for overall composition

206

5.3. Tests for residual moisture

206

5.4. Tests for filled containers

207

Part 6. Identification of extraneous agents and other contaminants

208

R. Lucken

R. Stolp

6.1. Sterility testing

208

6.2. Mycoplasma testing

209

6.3. Testing for extraneous viruses

209

Part 7. Identity and conformity testing

211

R. Lucken

R. Stolp

Part 8. Potency and safety testing

212

R. Lucken

R. Stolp

Part 9. Stability testing

215

R. Lucken

R. Stolp

D. Fawthrop

9.1. Real-time vs. Accelerated stability data

216

9.2. Comparison of the requirements for stability testing in the EU and in the USA

216

9.3. Variations to marketing authorisations

218