Veterinary Vaccines and Diagnostics Volume 41 pdf

CHAPMAN, Department of Veterinary Science, Louisiana Agri- cultural Experiment Station, Louisiana State University Agri- cultural Center, Baton Rouge, Louisiana 70803 389 Glasgow G61 1QH

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Volume 41

Veterinary Vaccines and Diagnostics

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Advances in Veterinary Medicine

Fred W Quimby Alan H Rebar Ronald D Schuhz

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Volume 41

Veterinary Vaccines and Diagnostics

E d i t e d by

Ronald D Schultz

Department of Pathobiological Sciences

School of Veterinary Medicine

University of Wisconsin-Madison

Madison, Wisconsin

A c a d e m i c P r e s s

San Diego London Boston

New York Sydney Tokyo Toronto

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This book is printed on acid-free paper ( ~

Copyright 9 1999 by ACADEMIC PRESS

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C O N T R I B U T O R S X X V

PREFACE X X X V

I VACCINES AND DIAGNOSTICS Historic and Contemporary Perspectives

Vaccination: A Philosophical View

MAR~_N C HORZINEK

I I n t r o d u c t i o n

II Will T h e r e B e V a c c i n a t i o n i n t h e N e x t M i l l e n i u m ?

III W h a t Is t h e F u t u r e of V e t e r i n a r y V a c c i n o l o g y ?

IV V a c c i n a t i o n i n t h e T w e n t y - F i r s t C e n t u r y

V O u t l o o k

Grease, Anthraxgate, and Kennel Cough: A Revisionist History of Early Veterinary Vaccines IAN TIZARD I I n t r o d u c t i o n 7

II T h e O r i g i n of V a c c i n i a 9

III A n t h r a x g a t e : A M i n o r N i n e t e e n t h - C e n t u r y S c a n d a l 11

IV E a r l y C a n i n e D i s t e m p e r V a c c i n e s 17

V S u m m a r y 22

R e f e r e n c e s 23

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Diagnostic Medicine: The Challenge of

Differentiating Infection from Disease and Making

J A M E S F E V E R M A N N A N D I N G E S E R I K S

I Introduction 25

II Differentiating Infection Detection from Disease Diagnosis 26

III How E a r l y Do We Want to Detect Infection? 31

IV W h a t Are the Consequences of the Results? 32

V W h e r e Are We H e a d i n g with V e t e r i n a r y Diagnostics? 34

References 36

II CONCEPTS IN IMMUNOLOGY AND VACCINOLOGY Genetic Effects on Vaccination B R U C E N W I L K I E A N D B O N N I E A M A L L A R D I Introduction 39

II Genetic Effects on H e a l t h a n d Vaccination 40

III S t r a t e g i e s for Genetic E n h a n c e m e n t of H e a l t h 41

IV H i g h I m m u n e Response P h e n o t y p e 44

V Discussion and S u m m a r y 48

References 50

Nutritional Effects on Vaccination M A R K E C O O K I Vaccination Cost to P e r f o r m a n c e 53

II Biochemical M e c h a n i s m s in I m m u n e - I n d u c e d Wasting 54

III Conjugated Linoleic Acid 55

IV Cholecystokinin and I m m u n e - I n d u c e d Anorexia 56

V S u m m a r y 57

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Effects of Stress on Leukocyte Trafficking and

Immune Responses: Implications for V a c c i n a t i o n

M E K E H R L I , J L B U R T O N , B J N O N N E C K E ,

AND E K LEE

I Introduction 61

II Leukocyte Trafficking 65

III Effects of Stress on Immunity 70

IV Summary 74

References 74

Role of Macrophage Cytokines in Mucosal Adjuvanticity D E N N I S L F o s s A N D M I C H A E L P M U R T A U G H I Introduction 83

II Mucosal Adjuvanticity of Cholera Toxin 84

III Mechanisms of Mucosal Adjuvanticity 92

IV Summary 98

References 99

Cholera Toxin B Subunit as an Immunomodulator for Mucosal Vaccine Delivery M I C H A E L W R U S S E L L , H O N G - Y I N W u , G E O R G E H A J I S H E N G A L L I S , S U S A N K H O L L I N G S H E A D , A N D S U Z A N N E M M I C H A L E K I Introduction 105

II Responses to Mucosal Immunization with SBR-CTA2/B 106

III Responses to Mucosal Immunization with Salmonella Expressing SBR-CTA2/B 108

IV Discussion and S u m m a r y 110

References 112

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viii CONTENTS

Deceptive Imprinting: Insights into Mechanisms

of I m m u n e E v a s i o n a n d V a c c i n e D e v e l o p m e n t

PETER L NARA

I I n t r o d u c t i o n a n d B a c k g r o u n d 115

II D e c e p t i v e I m p r i n t i n g 117

III R e f o c u s i n g t h e I m m u n e R e s p o n s e b y M a s k i n g E p i t o p e s R e s p o n s i b l e for D e c e p t i v e I m p r i n t i n g : Novel A p p r o a c h to V a c c i n a t i o n 129

Vaccination against Tuberculosis: Recent Progress IAN M ORME I I n t r o d u c t i o n 135

II A c q u i r e d I m m u n i t y a n d M e m o r y I m m u n i t y to T u b e r c u l o s i s I n f e c t i o n 136

III T y p e s of Vaccines 138

IV C a n We I n c r e a s e H e r d R e s i s t a n c e to B o v i n e T u b e r c u l o s i s ? 141

Viral Vectors for Veterinary Vaccines M I C H A E L S H E P P A R D I I n t r o d u c t i o n a n d B a c k g r o u n d 145

II Viral Vector C o n s t r u c t i o n 147

III A d v a n t a g e s a n d D i s a d v a n t a g e s of Viral Vectors for Vaccine D e l i v e r y 148

IV C o n s t r u c t i o n of S a f e r Viral Vectors for Vaccine D e l i v e r y 149

V E x a m p l e s of R e p o r t e d Viral V e t e r i n a r y Vaccine Vectors 151

VI C o m m e r c i a l l y Available Viral Vaccine Vectors for V e t e r i n a r y U s e 151

VII S u m m a r y 153

DNA Immunization: Present and Future L A BABIUK, J LEwIs, S VAN DEN HURK, AND R BRAUN I I n t r o d u c t i o n 163

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III I n d u c t i o n of I m m u n i t y 166

IV Role of D i f f e r e n t A n t i b o d i e s in C l e a r i n g V i r u s e s 168

V Vaccine D e l i v e r y 169

VI D N A I m m u n i z a t i o n in t h e F a c e of P a s s i v e A n t i b o d y 171

VII R e g u l a t o r y 172

VIII E p i l o g u e 174

Contribution of Advances in Immunology to Vaccine Development W I M O R R I S O N , G T A Y L O R , R M G A D D U M , A N D S A ELLIS I I n t r o d u c t i o n 181

II A d v a n c e s in I m m u n o l o g y R e l e v a n t to Vaccine D e v e l o p m e n t 182

III M e c h a n i s m s of I m m u n e P r o t e c t i o n a g a i n s t Bovine R e s p i r a t o r y S y n c y t i a l Virus 187

IV S u m m a r y 192

III BOVINE VACCINES AND DIAGNOSTICS Bovine Viral Vaccines, Diagnostics, and Eradication: Past, Present, and Future JAN T VAN OIRSCHOT I I n t r o d u c t i o n 197

II F o o t - a n d - M o u t h D i s e a s e 198

III I n f e c t i o u s Bovine R h i n o t r a c h e i t i s 201

IV Bovine V i r u s D i a r r h e a 207

V P o s t e r a d i c a t i o n P e r i o d 210

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Immunization and Diagnosis in Bovine

Reproductive Tract Infections

L Y N E T T E B C O R B E I L

I Introduction and B a c k g r o u n d 217

II Brucella abortus Infection 218

III H a e m o p h i l u s somnus Infection 219

IV Campylobacter fetus subsp, venerealis Infection 221

V Tritrichomonas foetus Infection 224

VI S u m m a r y and F u t u r e Directions 232

References 233

Progress and Expectations for Helminth Vaccines E L S N T M E E U S E N A N D J I L L I A N F M A D D O X I Introduction 241

II Vaccination Using Defined P a r a s i t e Antigens 242

III Vaccine-Induced I m m u n e Responses 245

IV Simulation Models for H o s t - P a r a s i t e Population Dynamics 247

V H o s t - I m m u n i t y and Population Dynamics of G a s t r o i n t e s t i n a l N e m a t o d e Infections 250

VI Development of a Simple Model for Vaccination a g a i n s t H a e m o n c h u s 251

VII S u m m a r y 253

References 254

Vaccines and Diagnostic Methods for Bovine Mastitis: Fact and Fiction R O B E R T J Y A N C E Y , J R I Introduction 257

II Vaccines for Contagious P a t h o g e n s 258

III Vaccines for E n v i r o n m e n t a l Mastitis P a t h o g e n s 263

IV Diagnostic Methods 267

V S u m m a r y 268

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T-Cell Responses and the Influence of Dendritic

Cells in Cattle

AND G P BEMBRIDGE

I I n t r o d u c t i o n 275

II I d e n t i f i c a t i o n of t h e M a j o r T-Cell S u b p o p u l a t i o n s in C a t t l e 276

III Role of D i f f e r e n t T-Cell P o p u l a t i o n s i n V i v o 276

IV I d e n t i f i c a t i o n of S u b p o p u l a t i o n s of CD4 a n d CD8 T Cells T h a t Differ in F u n c t i o n 278

V A c t i v a t i o n R e q u i r e m e n t s a n d F u n c t i o n of ~/3 T Cells 282

VI T-Cell R e s p o n s e s I n d u c e d b y D e n d r i t i c Cells 284

IV CANINE AND FELINE VACCINES Canine Viral Vaccines at a Turning P o i n t - - A Personal Perspective L E CARMICHAEL I G e n e r a l R e m a r k s 289

II V e t e r i n a r y Vaccines 292

III C o m m e n t s on Selected Vaccines 293

IV S u m m a r y 302 R e f e r e n c e s 305

Forty Years of Canine Vaccination M J G APPEL I I n t r o d u c t i o n 309

II R a b i e s Virus 311

III C a n i n e D i s t e m p e r Virus 311

IV C a n i n e P a r v o v i r u s 312

V C a n i n e C o r o n a v i r u s 313

VI C a n i n e A d e n o v i r u s Type 1 (Infectious C a n i n e H e p a t i t i s Virus) 314

VII C a n i n e A d e n o v i r u s Type 2 314

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xii CONTENTS

I X B o r d e t e l l a b r o n c h i s e p t i c a 315

X B o r r e l i a b u r g d o r f e r i 316

XI L e p t o s p i r o s i s 317

XII S u m m a r y 318

Analysis of the Protective Immunity Induced by Feline Immunodeficiency Virus Vaccination M A R G A R E T J H O S I E A N D O S W A L D J A R R E T T I I n t r o d u c t i o n a n d B a c k g r o u n d 325

II W h o l e I n a c t i v a t e d Virus Vaccines 326

III S u b u n i t Vaccines 328

IV D N A Vaccination 329

Vaccination of Cats against Emerging and Reemerging Zoonotic Pathogens C H R I S T O P H E R W O L S E N I I n t r o d u c t i o n 333

II T o x o p l a s m a g o n d i i 336

III B a r t o n e l l a h e n s e l a e 338

IV H e l i c o b a c t e r p y l o r i 341

V O t h e r A g e n t s 341

VI S u m m a r y 342

Evaluation of Risks and Benefits Associated with Vaccination against Coronavirus Infections in Cats F R E D W S C O T T I H i s t o r i c a l P e r s p e c t i v e s of F I P 347

II C u r r e n t S t a t u s of F I P 348

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IV P a t h o g e n e s i s of F e l i n e C o r o n a v i r u s Infections 349

V I m m u n o l o g y of F e l i n e C o r o n a v i r u s Infections 350

VI A n t i b o d y - D e p e n d e n t E n h a n c e m e n t 351

VII F I P Vaccine 351

VIII R i s k s of F I P V a c c i n a t i o n 352

IX Benefits of F I P V a c c i n a t i o n 353

V EQUINE VACCINES AND DIAGNOSTICS Diagnosis and Prevention of Equine Infectious Diseases: Present Status, Potential, and Challenges for the F u t u r e P H I L I P P E D E S M E T T R E I I n t r o d u c t i o n 359

II Viral D i s e a s e s 360

III B a c t e r i a l D i s e a s e s 368

IV O t h e r Viral a n d B a c t e r i a l D i s e a s e s 371

V S u m m a r y , 372

The Equine Influenza Surveillance Program J A MUMFORD I I n t r o d u c t i o n 379

II 1983: W H O I n f o r m a l W o r k s h o p on V a c c i n a t i o n a g a i n s t E q u i n e I n f l u e n z a 380 III 1992: W H O / O I E C o n s u l t a t i o n on N e w l y E m e r g i n g S t r a i n s of E q u i n e I n f l u e n z a 381

IV 1995: C o n s u l t a t i o n of O I E a n d W H O E x p e r t s on P r o g r e s s in S u r v e i l l a n c e of E q u i n e I n f l u e n z a a n d A p p l i c a t i o n to S t r a i n Selection 382

V 1996: Actions T a k e n by t h e O I E 383

VI F i n d i n g s of t h e E x p e r t S u r v e i l l a n c e P a n e l 384

VII Action T a k e n by t h e E u r o p e a n P h a r m a c o p o e i a 385

VIII Actions T a k e n by t h e C o m m i t t e e for V e t e r i n a r y M e d i c i n a l P r o d u c t s 385

IX Actions T a k e n by t h e N a t i o n a l I n s t i t u t e of Biological S t a n d a r d i z a t i o n a n d C o n t r o l 386

X Action T a k e n b y t h e U S D A 386

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x i v CONTENTS

Vaccination against Strongylus vulgaris in Ponies: Comparison of the Humoral and Cytokine

Responses of Vaccinates and Nonvaccinates

C E S W I D E R S K I , T R K L E I , R W F O L S O M , S S POURCIAU, A

W T A Y L O R , A N D D W H O R O H O V

I Introduction 390

II Methods 391

III Results 395

IV Discussion 397

References 402

Io II III IV V VI VII VIII IX ISCOM: A Delivery System for Neonates and for Mucosal Administration B M O R E I N , M V I L L A C R E S - E R I K S S O N , J E K S T R O M , K Hu, S BEHBOUDI, AND K LOVGREN-BENGTSSON Introduction: I m m u n e S t i m u l a t i n g Complex 405

The ISCOM Concept 406

Formation of ISCOM 406

Antigen Presentation and Targeting by ISCOMs 407

Adjuvant Influences on the Transport of Antigen 408

Adjuvants and Delivery Systems for Induction of Mucosal I m m u n i t y 409

ISCOMs Induce a Cytokine T h l Type Response But Also Th2 410

Antigens Loaded in ISCOMs Induce I m m u n e Response in Neonates 410

Protective I m m u n i t y 411

References 412

An Epidemiologic Approach to Evaluating

the Importance of Immunoprophylaxis

P A U L S M O R L E Y

415

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VI SWINE VACCINES

Present Uses of and E x p e r i e n c e s

with Swine Vaccines

L E N N A R T B A C K S T R O M

I Introduction 419

II M a t e r i a l 421

III Results 422

IV Discussion 425

References 427

Enteric Viral Infections of Pigs and Strategies for Induction of Mucosal Immunity L I N D A J S A I F I Introduction a n d B a c k g r o u n d 429

II Characteristics of E n t e r o p a t h o g e n i c Viruses 430

III Mucosal I m m u n i t y to E n t e r o p a t h o g e n i c Viruses 434

References 442

Use of Interleukin 12 to Enhance the Cellular Immune Response of Swine to an Inactivated Herpesvirus Vaccine F E D E R I C O A Z U C K E R M A N N , S T E P H E N M A R T I N , R O B E R T J HUSMANN, A N D J U L I E B R A N D T I I n t r o d u c t i o n 447

II Cytokines as Vaccine A d j u v a n t s 448

III I n t e r l e u k i n 12 a n d Its Ability to Modulate Acquired I m m u n i t y 449

IV Porcine Model to E x a m i n e the A d j u v a n t Effect of I n t e r l e u k i n 12 451

V I m m u n e Mechanism(s) of Protective I m m u n i t y a g a i n s t H e r p e s v i r u s 452

VI I n t e r l e u k i n 12-Mediated E n h a n c e m e n t of the Cell-Mediated I m m u n e Response to an I n a c t i v a t e d P r V Vaccine 455

VII S u m m a r y a n d Conclusion 456

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Swinepox Virus as a Vaccine Vector

for Swine Pathogens

D E O K I N T R I P A T H Y

I I n t r o d u c t i o n 463

II Conventional Vaccines 465

III R e c o m b i n a n t Virus Vectored Vaccines 467

VII POULTRY VACCINES Introduction to Poultry Vaccines and Immunity J M SHARMA I I n t r o d u c t i o n 481

II Disease P r e v e n t i o n by Vaccination 482

III Vaccination P r o g r a m s 484

IV Vaccine Delivery 485

V N e w D e v e l o p m e n t s in P o u l t r y Vaccines 486

VI G e n e r a l F e a t u r e s of t h e Avian I m m u n e S y s t e m 487

VII H u m o r a l I m m u n i t y 488

VIII Cell-Mediated I m m u n i t y 489

IX S u m m a r y 490

In Ovo V a c c i n a t i o n T e c h n o l o g y C A RICKS, A AVAKIAN, T B R Y A N , R G I L D E R S L E E V E , E H A D D A D , R ILICH, S K I N G , L MURRAY, P PHELPS, R P O S T O N , C W H I T F I L L , A N D C W I L L I A M S I I n t r o d u c t i o n 495

II Technology Discovery 496

III Commercialization of In Ovo M a r e k ' s (HVT/SB1) Vaccination 497

IV C o m m e r c i a l i z a t i o n of O t h e r In Ovo Live Viral Vaccines 503

V M a t e r n a l A n t i b o d y Effects on Viral Vaccine Efficacy 505

VI Safe a n d Effective Vaccination in P r e s e n c e of M a t e r n a l Antibodies 506

VII B a c t e r i a l Vaccines 511

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IX S u m m a r y 512

Current and Future Recombinant Viral Vaccines for Poultry M A R K W J A C K W O O D I I n t r o d u c t i o n a n d B a c k g r o u n d 517

II Virus Vectors 517

III F u t u r e R e c o m b i n a n t Vaccines for P o u l t r y 519

VIII FISH, EXOTIC, AND WILDLIFE VACCINES Development and Use of Modified Live EdwardsieUa ictaluri Vaccine against Enteric Septicemia of Catfish PHILLIP H KLESIUS AND CRAIG A SHOEMAKER I I n t r o d u c t i o n 523

II M a t e r i a l s a n d M e t h o d s 525

III R e s u l t s 527

IV D i s c u s s i o n 532

V S u m m a r y 534

Fish Vaccines S O M S A K V I N I T N A N T H A R A T , K J E R S T I G R A V N I N G E N , A N D E V A N G R E G E R I I n t r o d u c t i o n 539

II I m m u n i z a t i o n M e t h o d s in F i s h 541

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xviii CONTENTS

IV Vaccines a g a i n s t Some Specific D i s e a s e s 543

V S u m m a r y 549

References 550 Cross-Species Vaccination in Wild a n d E x o t i c Animals J O S E P H F C U R L E E , J R I I n t r o d u c t i o n

II C a n i n e D i s t e m p e r Virus

III C l o s t r i d i u m b o t u l i n u m T y p e C

IV S u m m a r y

R e f e r e n c e s

551 551 553 555 555 Some Experiments and Field Observations of Distemper in Mink a n d Ferrets J O H N R G O R H A M I I n t r o d u c t i o n 557

II Vaccines 558

III R o u t e s of Vaccination 562

IV M a t e r n a l A n t i b o d y a n d Vaccination 562

V Vaccination of P r e g n a n t F e m a l e M i n k 563

VI T r a n s p l a c e n t a l a n d N e o n a t a l A t t e m p t s to I m m u n i z e F e r r e t s a g a i n s t CDV 564

VII Time I n t e r v a l R e q u i r e d to Infect F e r r e t s by Direct C o n t a c t 564

VIII E x p e r i m e n t a l Epidemiology 565

IX F u t u r e R e s e a r c h 567

Vaccination of Wildlife against Rabies: Successful Use of a Vectored Vaccine Obtained by R e c o m b i n a n t Technology M M _ A C K O W I A K , J MAKI, L M O T E S - K R E I M E Y E R , T H A R B I N , AND K VAN KAMPEN I I n t r o d u c t i o n a n d B a c k g r o u n d 571

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III U S D A T e s t i n g of R e c o m b i n a n t Vaccines 573

IV C o n t r o l l i n g Raccoon R a b i e s 576

V R a b i e s in Texas: Coyotes a n d G r a y F o x e s 580

IX REGULATION, LICENSING, AND STANDARDIZATION OF VACCINES AND DIAGNOSTICS Authorities and Procedures for Licensing Veterinary Biological Products in the United States D A V I D A E S P E S E T H A N D T H O M A S J M Y E R S I I n t r o d u c t i o n 585

II O r g a n i z a t i o n 586

III L i c e n s i n g P r o c e d u r e s for C o n v e n t i o n a l Vaccines a n d B a c t e r i n s 587

IV L i c e n s i n g P r o c e d u r e s for N o n c o n v e n t i o n a l P r o d u c t s 590

V C o n d i t i o n a l L i c e n s e s 591

VI Licenses for F u r t h e r M a n u f a c t u r e 591

VII S u b l i c e n s i n g 592

VIII E x e m p t i o n s to L i c e n s u r e 592

IX A u t o g e n o u s P r o d u c t s 592

X S u m m a r y 593

R e f e r e n c e 593

Licensing Procedures for Immunological Veterinary Medicinal Products in the European Union P P PASTORET AND F FALIZE I I n t r o d u c t i o n 595

II Role of t h e E u r o p e a n A g e n c y for t h e E v a l u a t i o n of M e d i c i n a l P r o d u c t s 596

III Available E u r o p e a n P r o c e d u r e s 597

IV N e w Definitions of V e t e r i n a r y Biologicals 598

V R e v i s i o n - V a l i d a t i o n of Vaccines A l r e a d y on t h e M a r k e t 600

VI M a n u f a c t u r i n g A u t h o r i z a t i o n 601

VII B a t c h C o n t r o l / R e l e a s e 602

VIII Special C a s e of E q u i n e I n f l u e n z a Vaccines 602

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X S u m m a r y 607

References 6 0 7

International Association of Biological

Standardization and International Harmonization

D A N I E L G A U D R Y

I I n t r o d u c t i o n 6 0 9

II I n t r o d u c i n g t h e I A B S 6 1 0 III A C a s e S t u d y : R e p o r t o f t h e A v i a n P r o d u c t s S t a n d a r d i z a t i o n C o m m i t t e e ( M a r c h 1979) 6 1 2

Technical Requirements for the Licensing

of Pseudorabies (Aujeszky's Disease) Vaccines

in the European Union

P VANNIER

II S a f e t y T e s t i n g 6 1 6 III E f f i c a c y T e s t i n g 6 2 0

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Why Do Vaccine Labels Say the Funny Things

IV Recommendations for Standardization Improvements 640

Standardization of Diagnostic Assays for Animal

Acute Phase Proteins

P D A V I D E C K E R S A L L , S U S A N D U T H I E ,

M A T H I L D A J M T O U S S A I N T , E R I K G R U Y S , P E T E R H E E G A A R D ,

M A R I A A L A V A , C O R N E L I A L I P P E R H E I D E ,

A N D F R A N C O I S M A D E C

I Introduction and Background 643

II Acute Phase Protein in Animals 645 III Methods of Acute Phase Protein Assay 647

IV Standardization of Acute Phase Protein Assays 649 References 653

Vaccination Practices in Veterinary

Medicine: Standardization versus

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xxii CONTENTS

International Harmonization of Standards for

Diagnostic Tests and Vaccines: Role of the Office

International des Epizooties PETER F W R I G H T

II O r g a n i z a t i o n a n d S t r u c t u r e 6 7 0 III S p e c i a l i s t C o m m i s s i o n s 672

IV S t a n d a r d s C o m m i s s i o n 672

V S u m m a r y 6 7 7

R e f e r e n c e s 6 7 9

X ADVERSE VACCINE REACTIONS, FAILURES, AND POSTMARKETING SURVEILLANCE

Mechanistic Bases for Adverse Vaccine Reactions

and Vaccine Failures

J A M E S A R O T H

II A d v e r s e Vaccine R e a c t i o n s 6 8 4 III V a c c i n e F a i l u r e 691

IV S u g g e s t e d I m p r o v e m e n t s i n P o s t m a r k e t i n g S u r v e i l l a n c e 706

V R i s k M a n a g e m e n t a n d R i s k C o m m u n i c a t i o n 709

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More Bumps on the Vaccine Road

W JEAN DODDS

I I n t r o d u c t i o n a n d B a c k g r o u n d 715

II Overview of Adverse Effects of Vaccines 716 III Breed S t u d y E x a m p l e s 719

IV Periodicity of Booster Vaccination 724

V A l t e r n a t i v e Strategies to Conventional Vaccination 727

VI S u m m a r y a n d F u t u r e Directions 729 References 729

Vaccine-Induced Autoimmunity in the Dog

H A R M H O G E N E S C H , J U A N A Z C O N A - O L I V E R A , C A T H A R I N E S C O T T -

M O N C R I E F F , P A U L W S N Y D E R , A N D L A R R Y W G L I C K M A N

I Introduction 733

II M a t e r i a l s a n d Methods 735 III Results 737

IV Discussion 740 References 745

An Introduction to Analytical Methods for the

Postmarketing Surveillance of Veterinary Vaccines

D A V I D S I E V

I Introduction 749

II P o s t m a r k e t i n g Surveillance a n d Public Policy 750 III P o s t m a r k e t i n g Surveillance D a t u m 751

IV F a t h o m i n g S p o n t a n e o u s Adverse E v e n t Report D a t a 754

V Q u a n t i t a t i v e Analysis of Adverse E v e n t Report D a t a 758

VI S u m m a r y 769 References 773

INDEX 775

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This Page Intentionally Left Blank

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N u m b e r s in p a r e n t h e s e s indicate t h e pages on w h i c h t h e a u t h o r s ' contributions begin

Zaragoza, Spain (643)

M J G APPEL, James A Baker Institute for Animal Health, College of Veterinary Medicine, Cornell University, Ithaca, New York 14853 (309)

A A v e , Embrex, Inc., P.O Box 13989, Research Triangle Park, North Carolina 27709 (495)

Veterinary Clinical Sciences, Purdue University, West Lafayette, Indiana 47907 (733)

L A BABIUK, Veterinary Infectious Disease Organization, Saskatoon, Saskatchewan, Canada S7N 5E3 (163)

Wisconsin, Madison, Wisconsin 53706 (419)

S BEHBOUDI, Department of Veterinary Microbiology, Section of Virol- ogy, Swedish University of Agricultural Sciences, Biomedical Cen- tre Box 585, S-751 23 Uppsala, Sweden (405)

RG20 7NN, United Kingdom (275)

Illinois, Urbana, Illinois 61801 (447)

R BRAUN, Veterinary Infectious Disease Organization, Saskatoon, Saskatchewan, Canada S7N 5E3 (163)

7NN, United Kingdom (275)

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M R CHAPMAN, Department of Veterinary Science, Louisiana Agri- cultural Experiment Station, Louisiana State University Agri- cultural Center, Baton Rouge, Louisiana 70803 (389)

Glasgow G61 1QH, United Kingdom (643)

J EKSTROM, Department of Veterinary Microbiology, Section of Virol- ogy, Swedish University of Agricultural Sciences, Biomedical Cen- tre Box 585, S-751 23 Uppsala, Sweden (405)

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S A ELLIS, Institute for Animal Health, Compton, Newbury, Berk- shire, United Kingdom (181)

College of Veterinary Medicine, Washington State University, Pull- man, Washington 99164 (25)

Plant Health Inspection Service, Veterinary Services, Center for Veterinary Biologics, Riverdale, Maryland 20782 (585)

Washington Animal Disease Diagnostic Laboratory, Washington State University, Pullman, Washington 99164 (25)

F FALIZE, Pharmaceutical Inspectorate, Ministry of Public Health, Belgium (595)

ogy, School of Veterinary Medicine, Louisiana State University, Ba- ton Rouge, Louisiana 70803 (389)

DENNIS L Foss, Department of Veterinary Pathobiology, University of Minnesota, St Paul, Minnesota 55108 (83)

shire, United Kingdom (181)

R GILDERSLEEVE, Embrex, Inc., P.O Box 13989, Research Triangle Park, North Carolina 27709 (495)

erinary Clinical Sciences, Purdue University, West Lafayette, Indi- ana 47907 (701, 733)

partment of Veterinary Microbiology and Pathology, Washington State University, Pullman, Washington 99164 (557)

Oslo, Norway (539)

vue, Washington, 98005 (539)

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xxviii CONTRIBUTORS

Yalelaan 1, 3508 TD Utrecht, The Netherlands (643)

E HADDAD, Embrex, Inc., P.O Box 13989, Research Triangle Park, North Carolina 27709 (495)

Alabama at Birmingham, Birmingham, Alabama 35924 (105)

W HARBIN, Merial, Limited, Athens, Georgia 30601 (571)

Frederiksburg, Denmark (643)

erinary Clinical Sciences, Purdue University, West Lafayette, Indi- ana 47907 (733)

versity, Utrecht, The Netherlands (1)

of Glasgow, Glasgow G61 1QH, United Kingdom (325)

K Hu, Department of Veterinary Microbiology, Section of Virology, Swedish University of Agricultural Sciences, Biomedical Centre Box

585, S-751 23 Uppsala, Sweden (405)

sity of Illinois, Urbana, Illinois 61801 (447)

sas 66225 (633)

R ILICH, Embrex, Inc., P.O Box 13989, Research Triangle Park, North Carolina 27709 (495)

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MARK W JACKWOOD, Department of Avian Medicine, College of Veter- inary Medicine, University of Georgia, Athens, Georgia 30602 (517)

OSWALD JARRETT, Department of Veterinary Pathology, University of Glasgow, Glasgow G61 1QH, United Kingdom (325)

S KING, Embrex, Inc., P.O Box 13989, Research Triangle Park, North Carolina 27709 (495)

T R KLEI, Department of Veterinary Microbiology and Parasitology, School of Veterinary Medicine, Louisiana State University, and De- partment of Veterinary Science, Louisiana Agricultural Experiment Station, Louisiana State University Agricultural Center, Baton Rouge, Louisiana 70803 (389)

cultural Research Service, Fish Diseases and Parasites Research Laboratory, Auburn, Alabama 36830 (523)

E K LEE, Iowa State University, Ames, Iowa 50011 (61)

Dame de la Paix, Namur, Belgium (275)

katchewan, Canada S7N 5E3 (163)

Bonn D5311, Germany (643)

K LOVGREN-BENGTSSON, Department of Veterinary Microbiology, Sec- tion of Virology, Swedish University of Agricultural Sciences, Bio- medical Centre Box 585, S-751 23 Uppsala, Sweden (405)

M MACKOWIAK, Merial, Limited, Athens, Georgia 30601 (571)

JILLIAN F MADDOX, Centre for Animal Biotechnology, School of Veter- inary Science, The University of Melbourne, Parkville, Victoria

3052, Australia (241)

France (643)

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XXX CONTRIBUTORS

J MAKI, Merial, Limited, Athens, Georgia 30601 (571)

inary College, The University of Guelph, Guelph, Ontario, Canada N1G 2Wl (39)

ELS N T MEEUSEN, Centre for Animal Biotechnology, School of Veter- inary Science, The University of Melbourne, Parkville, Victoria

3052, Australia (241)

R M MOORE, Department of Veterinary Clinical Sciences, School of Veterinary Medicine, Louisiana State University, Baton Rouge, Louisiana 70803 (389)

B MOREIN, Department of Veterinary Microbiology, Section of Virol- ogy, Swedish University of Agricultural Sciences, Biomedical Cen- tre Box 585, S-751 23 Uppsala, Sweden (405)

PAUL S MORLEY, Department of Veterinary Preventive Medicine, The Ohio State University, Columbus, Ohio 43210-1092 (415)

Berkshire, United Kingdom (181)

L MOTES-KREIMEYER, Merial, Limited, Athens, Georgia 30601 (571)

J A MUMFORD, Centre for Preventive Medicine, Animal Health Trust, Newmarket, Suffolk, England (379)

North Carolina 27709 (495)

MICHAEL P MURTAUGH, Department of Veterinary Pathobiology, Uni- versity of Minnesota, St Paul, Minnesota 55108 (83)

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THOMAS J MYERS, U.S Department of Agriculture, Animal and Plant Health Inspection Service, Veterinary Services, Center for Veterin- ary Biologics, Riverdale, Maryland 20782 (585)

PETER L NARA, Biological Mimetics Inc., Frederick, Maryland 21702 (115)

School of Veterinary Medicine, University of Wisconsin-Madison,

2015 Linden Drive West, Madison, Wisconsin 53706 (333)

cine and Biomedical Sciences, Colorado State University, Fort Col- lins, Colorado 80523 (135)

Veterinary Medicine, University of Liege, Sart Tilman, B-4000 Liege, Belgium (595)

P PHELPS, Embrex, Inc., P.O Box 13989, Research Triangle Park, North Carolina 27709 (495)

R BOSTON, Embrex, Inc., P.O Box 13989, Research Triangle Park, North Carolina 27709 (495)

C A RICKS, Embrex, Inc., P.O Box 13989, Research Triangle Park, North Carolina 27709 (495)

logics, College of Veterinary Medicine, Iowa State University, Ames, Iowa 50011 (681)

bama at Birmingham, Birmingham, Alabama 35924 (105)

cultural Research and Development Center, The Ohio State Univer- sity, Wooster, Ohio 44691 (429)

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xxxii CONTRIBUTORS

FRED W SCOTT, Cornell Feline Health Center and the Department of Microbiology and Immunology, College of Veterinary Medicine, Cor- nell University, Ithaca, New York 14853 (347)

CATHARINE SCOTT-MONCRIEFF, Departments of Veterinary Pathobiol- ogy and Veterinary Clinical Sciences, Purdue University, West La- fayette, Indiana 47907 (733)

J M SHARMA, Veterinary PathoBiology, College of Veterinary Medi- cine, University of Minnesota, St Paul, Minnesota 55108 (481) MICHAEL SHEPPARD, Animal Health Biological Discovery, Pfizer Cen- tral Research, Groton, Connecticut 06340 (145)

ricultural Research Service, Fish Diseases and Parasites Research Laboratory, Auburn, Alabama 36830 (523)

DAVID SIEV~ Center for Veterinary Biologics, U.S Department of Agri- culture, 510 South 17th Street, Ames, Iowa 50010 (749)

inary Clinical Sciences, Purdue University, West Lafayette, Indiana

47907 (733)

Health Inspection Service, Veterinary Services, Center for Veterin- ary Biologics, Licensing and Policy Development, Riverdale, Mary- land 20737 (627)

sitology, School of Veterinary Medicine, Louisiana State University, Baton Rouge, Louisiana 70803 (389)

G TAYLOR, Institute for Animal Health, Compton, Newbury, Berk- shire, United Kingdom (181)

H W TAYLOR, Department of Veterinary Pathology, School of Veterin- ary Medicine, Louisiana State University, Baton Rouge, Louisiana

70803 (389)

IAN TIZARD, Department of Veterinary Pathobiology, Texas A&M Uni- versity, College Station, Texas 77843 (7)

University, Yalelaan 1, 3508 TD Utrecht, The Netherlands (643)

Trang 34

DEOKI N TRIPATHY, Department of Veterinary Pathobiology, Univer- sity of Illinois, Urbana, Illinois 61802 (463)

S VAN DEN HURK, Veterinary Infectious Disease Organization, Saska- toon, Saskatchewan, Canada S7N 5E3 (163)

K VAN KAMPEN, The Van Kampen Group, Ogden, Utah (571)

JAN T VAN OIRSCHO% Department of Mammalian Virology, Institute of Animal Science and Health, 8200 AB Lelystad, The Netherlands (197)

P VANNIER, Cneva Zoop61e, Les Croix, BP 53 22400 Ploufragan, France (615)

M VILLACRES-ERIKSSON, Department of Veterinary Microbiology, Sec- tion of Virology, Swedish University of Agricultural Sciences, Bio- medical Centre Box 585, S-751 23 Uppsala, Sweden (405)

vision, Bellevue, Washington, 98005 (539)

V WEYNANTS, Immunology Unit, Facultes Universitaires, Notre Dame

de la Paix, Namur, Belgium (275)

C WHITFILL, Embrex, Inc., P.O Box 13989, Research Triangle Park, North Carolina 27709 (495)

ary College, The University of Guelph, Guelph, Ontario, Canada NIG 2Wl (39)

C WILLIAMS, Embrex, Inc., P.O Box 13989, Research Triangle Park, North Carolina 27709 (495)

PETER F WRIGHT, Canadian Food Inspection Agency, National Centre for Foreign Animal Disease, Winnipeg, Manitoba, Canada R3E 3M4 (669)

Birmingham, Birmingham, Alabama 35924 (105)

Central Research, Groton, Connecticut 06340 (257)

University of Illinois, Urbana, Illinois 61801 (447)

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This book presents a comprehensive view of veterinary vaccines and diagnostics~past, present, and future The authors were all partici- pants in the First International Veterinary Vaccines and Diagnostics Conference (IVVDC) held during the summer of 1997 at the Monona Terrace Convention Center, Madison, Wisconsin, USA,

Each session had co-chairs who selected four to six speakers The book follows the general organization of the conference The sessions and co-chairs were:

Vaccines and Diagnostics in Veterinary Medicine: Historical and Contemporary Perspectives, Dr Ronald D Schultz

Basic and Applied Immunology and Vaccinology, Dr Pat Shewen and Dr Chuck Czuprynski

Adjuvants and Immunomodulators, Dr Gary Splitter and Dr Mi- chael P Murtaugh

Canine Vaccines and Diagnostics, Dr Leland E Carmichael and Dr Max Appel

Porcine Vaccines and Diagnostics, Dr Linda J Saif and Dr Lennart B~ickstrSm

Feline Vaccines and Diagnostics, Dr Mary Tompkins and Dr Fred

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of Wisconsin-Madison; American Association of Veterinary Immunolo- gists; Bayer Animal Health; Boehringer Ingelheim Animal Health, Inc.; Ft Dodge Laboratories; Grand Laboratories, Inc.; HESKA Corpo- ration; IDEXX Laboratories, Inc.; Intervet; Merck Research Laborato- ries (now Merial Ltd.); Pfizer Animal Health; and Rhone Merieux, Inc (now Merial Ltd.)

The topics covered herein are especially timely because of the many changes and new developments in veterinary vaccinology and diagnostics that have taken place during the past 10 years Information on vaccines and diagnostics for virtually all the major animal species, both wild and domesticated, is included There are many discussions

on new methodologies currently being used to develop safer and more effective vaccines and for the development of rapid, effective, and simple diagnostics In veterinary medicine, in contrast to h u m a n medicine, vaccines and associated diagnostics must be cost effective; thus, certain vaccines and diagnostics must sell for pennies if they are to be used for selected species, such as poultry Monetary restrictions rather than any scientific/technological constraints place more significant constraints on the development of products for many of the domesticated species served by veterinary medicine New methodologies, especially those resulting from advances in recombinant DNA technology, are making possible the development of vaccines for diseases for which there are no conventional vaccines and of replacement of conventional vaccines with safer and/or more effective vaccines as needed New and improved diagnostics, some of which can be used with special "marker vaccines" to control or maybe some day eradicate certain diseases, are also presented Contributors discuss methods for licensing vaccines and standardizing certain procedures and protocols worldwide to im- prove and simplify certain processes that are highly diverse and costly Global distribution of many of the vaccines and diagnostics makes harmonization necessary and will help ensure the cost effectiveness of the new products

An especially timely discussion focuses on the frequency of administration of vaccines and the adverse reactions associated with vaccines

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All the authors acknowledge the major contributions vaccines have made and will continue to make in the control of animal diseases The major accomplishments in the improvement of animal health and well- being achieved through the use of m a n y of the vaccines and diagnostics currently available are readily apparent However, m a n y vaccines are being given too often to animals t h a t will benefit little or not at all from the specific vaccines As illustrated by several authors, there are also vaccines t h a t can cause severe adverse reactions in certain animals and there are vaccines providing little or no economic benefit for the target species; in fact, they m a y create an economic loss Diagnostics

t h a t need to be improved with regard to sensitivity and/or specificity and the need for standardization and/or improved quality assurance programs are also discussed

The frequency of vaccination is an especially common theme with respect to canine and feline vaccines It is readily a p p a r e n t to most of the authors t h a t vaccines are designed to generate an "immunologic memory" t h a t lasts for years or often for the life of the animal It is also acknowledged t h a t the current practice of a n n u a l revaccination is not necessary for m a n y of the products used in cats and dogs and recommendations for a n n u a l vaccinations were made primarily to get pet owners to bring their pets to the v e t e r i n a r i a n for a n n u a l physical ex- aminations However, the recommendation for a n n u a l revaccinations becomes less acceptable with increased adverse reactions, especially those t h a t cause significant disease or death (for example, ana- phylaxis, vaccine-associated fibrosarcomas) and as more and more vaccines become available Adverse reactions and i m m u n e responses

to self-antigens have led to the reexamination of the a n n u a l revaccination recommendation, a recommendation t h a t has no scientific basis! For those vaccines with a long duration of i m m u n i t y (for example, viral vaccines), it has been suggested t h a t vaccination occur once every three to five years, instead of annually Certain vaccines should not be given at all to animals, especially those at low or no risk of disease

It is obvious t h a t there are m a n y safe and effective vaccines now available for m a n y species, but even more obvious is t h a t the f u t u r e will bring m a n y new vaccines These new vaccines will include some

t h a t are safer and/or more effective t h a n current vaccines and some for diseases for which no vaccines exist Also new, totally different types of vaccines will appear on the m a r k e t (for example, cancer vaccines, vaccines to prevent pregnancy) The frequency of vaccination will need to

be determined for these new products, and frequency should be based

on the true duration of immunity It will be as i m p o r t a n t not to over- vaccinate as it will be to ensure t h a t as m a n y animals as possible

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xxxviii PREFACE

receive the benefit of a vaccine for diseases t h a t cause significant mor- bidity and mortality Likewise, it will be i m p o r t a n t to ensure t h a t vaccines are not used in animals t h a t will receive little or no benefit or

in circumstances where the vaccines m a y cause harm

Vaccines for prevention and t r e a t m e n t of cancer, for n e u t e r i n g pet animals and wildlife species, and for losing or gaining weight are j u s t a few of the novel applications being developed Vaccines t h a t do not need to be injected but t h a t can instead be fed or aerosolized or given in the w a t e r are required for certain species Improved delivery methods will increase compliance for vaccines and decrease the costs associated with vaccinating food animal species and wildlife Completely revolu- tionary vaccines t h a t do not contain an antigen, only the genetic information to instruct the animal to m a k e the antigen, are now available These vaccines, DNA/nucleic acid vaccines, are creating a significant

a m o u n t of interest because they a p p e a r to be as effective as modified live vaccines (the most effective type c u r r e n t l y available) and safer

t h a n killed vaccines

These are exciting times in vaccinology and diagnostic medicine, primarily because technology is providing an opportunity to m a k e new and more effective products t h a t can be readily delivered to a large

n u m b e r of animals including wildlife species when and as needed Availability of this new technology alone should not and cannot drive product development We m u s t stop and ask the question, "Do we need the vaccine or the diagnostic?" We should not merely ask, "Can we

RONALD D SCHULTZ

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VACCINES AND DIAGNOSTICS Historic and Contemporary Perspectives

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