EUROPEAN COMMISSION HEALTH and CONSUMER PROTECTION DIRECTORATE-GENERAL Directorate C - Scientific Opinions C2 - Management of scientific committees; scientific co-operation and networks Diagnostic Techniques and Vaccines for Foot-and-Mouth Disease, Classical Swine Fever, Avian Influenza and some other important OIE List A Diseases Report of the Scientific Committee on Animal Health and Animal Welfare Adopted 24-25th April 2003 TABLE OF CONTENTS 1. ABBREVIATIONS.....................................................................................................6 2. MANDATE.................................................................................................................9 3. BACKGROUND.........................................................................................................9 4. PREAMBLE..............................................................................................................10 5. RECENT DEVELOPMENTS IN THE DIAGNOSIS OF INFECTIOUS DISEASES ................................................................................................................14 5.1. Introduction .....................................................................................................14 5.2. Screening of animal products ..........................................................................19 5.3. Nucleic acid amplification methods ................................................................19 5.3.1. Extraction of nucleic acid from the test sample ................................20 5.3.2. Target amplification systems.............................................................21 5.3.3. Transcription-based amplification systems .......................................23 5.4. DNA Microarrays............................................................................................25 5.5. Immunoassays .................................................................................................25 5.5.1. ELISA................................................................................................26 5.5.2. Chemiluminescent and fluorometric immunoassay procedures........28 5.5.3. Other immunoassays .........................................................................29 6. STANDARDISING AND VALIDATING NEW TECHNIQUES...........................30 6.1. Current approaches..........................................................................................30 6.2. The present situation with regard to reference standards and proficiency testing ...........................................................................................35 7. SOME ADVANCES IN THE DEVELOPMENT OF VETERINARY VACCINOLOGY......................................................................................................38 8. FOOT-AND-MOUTH DISEASE .............................................................................39 8.1. Diagnostic methods that are currently used.....................................................40 8.1.1. Investigation of Suspect Cases ..........................................................40 8.1.2. Tracing...............................................................................................41 8.1.3. Freedom of Infection .........................................................................41 8.2. New and emerging diagnostic techniques .......................................................42 8.3. Types of vaccine..............................................................................................42 8.4. Efficacy............................................................................................................43 8.5. Safety...............................................................................................................44 8.6. Quality .............................................................................................................44 8.7. Emergency vaccine banks ...............................................................................45 2 8.8. Differentiation of infected from vaccinated animals.......................................47 8.8.1. The current status of NSP serology ...................................................48 8.9. Application of vaccine in the field ..................................................................50 8.10. Future candidate vaccines................................................................................51 8.10.1. Inactivated antigens/subunit/peptide .................................................52 8.10.2. DNA vaccines....................................................................................54 8.10.3. Live attenuated viruses and live viral vectors ...................................54 8.10.4. Adjuvants...........................................................................................56 8.10.5. Marker vaccines.................................................................................58 9. CLASSICAL SWINE FEVER..................................................................................59 9.1. Diagnostic methods that are currently used.....................................................60 9.1.1. Investigation of Suspect Cases ..........................................................60 9.1.2. Tracing...............................................................................................62 9.1.3. Freedom of Infection .........................................................................63 9.2. New and emerging diagnostic techniques .......................................................63 9.3. Types of vaccine..............................................................................................63 9.3.1. Live attenuated ..................................................................................63 9.3.2. E2 subunit marker vaccines...............................................................63 9.4. Efficacy............................................................................................................64 9.4.1. Live attenuated vaccines....................................................................64 9.4.2. E2 subunit marker vaccine ................................................................65 9.5. Safety...............................................................................................................66 9.5.1. Live attenuated vaccines....................................................................66 9.5.2. E2 subunit marker vaccines...............................................................67 9.6. Differentiation of infected from vaccinated animals.......................................67 9.7. Application of vaccine in the field ..................................................................69 9.7.1. Domestic pigs ....................................................................................69 9.7.2. Wild boar...........................................................................................70 9.8. Future candidate vaccines................................................................................71 9.8.1. Viral vector vaccines .........................................................................72 9.8.2. DNA vaccines....................................................................................72 9.8.3. Genetically engineered live CSFV vaccines .....................................73 9.8.4. Chimeric pestiviruses ........................................................................73 9.8.5. Trans-complemented CSFV deletion mutants (replicons)................74 10. AVIAN INFLUENZA...............................................................................................74 10.1. Diagnostic methods that are currently used.....................................................76 3 10.1.1. Investigation of Suspect Cases ..........................................................76 10.1.2. Tracing...............................................................................................78 10.1.3. Freedom of Infection .........................................................................78 10.2. New and emerging diagnostic techniques .......................................................78 10.3. Types of vaccine..............................................................................................80 10.3.1. Inactivated homologous vaccines......................................................80 10.3.2. Inactivated heterologous vaccines.....................................................80 10.3.3. Live vaccines.....................................................................................80 10.3.4. Recombinant vaccines .......................................................................80 10.4. Efficacy............................................................................................................80 10.4.1. Live recombinant vaccines ................................................................81 10.5. Safety...............................................................................................................81 10.6. Differentiation of infected from vaccinated animals.......................................82 10.7. Application of vaccine in the field. .................................................................83 10.8. Future candidate vaccines................................................................................85 10.8.1. Subunit vaccines................................................................................85 10.8.2. DNA vaccines....................................................................................85