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Campus Veterinaire De Lyon VETAGRO SUP CAMPUS VETERINAIRE DE LYON Année 2019 - Thèse n°093 LES AUTOVACCINS EN MEDECINE VETERINAIRE, UTILISATIONS CHEZ LES RUMINANTS, PERSPECTIVES ET REGLEMENTATION THESE Présentée à l’UNIVERSITE CLAUDE-BERNARD - LYON I (Médecine - Pharmacie) et soutenue publiquement le 25 novembre 2019 pour obtenir le grade de Docteur Vétérinaire par BESSON Romain Né le 22 mai 1995 à Paris (75) VETAGRO SUP CAMPUS VETERINAIRE DE LYON Année 2019 - Thèse n°093 LES AUTOVACCINS EN MEDECINE VETERINAIRE, UTILISATIONS CHEZ LES RUMINANTS, PERSPECTIVES ET REGLEMENTATION THESE Présentée à l’UNIVERSITE CLAUDE-BERNARD - LYON I (Médecine - Pharmacie) et soutenue publiquement le 25 novembre 2019 pour obtenir le grade de Docteur Vétérinaire par BESSON Romain Né le 22 mai 1995 à Paris (75) 3 4 REMERCIEMENTS AU JURY A Monsieur le Professeur Frédéric Bérard, De l’Université Claude Bernard – Faculté de médecine Lyon Sud – Charles Merieux, Pour m’avoir fait l’honneur d’accepter la présidence du jury, Hommages respectueux. A Monsieur le Professeur Didier Pin, De VetAgro-sup Campus Vétérinaire de Lyon, Pour m’avoir fait l’honneur d’encadrer et corriger ce travail, Mes sincères remerciements. A Madame la Docteure Claire Becker, De VetAgro-sup Campus Vétérinaire de Lyon, Pour m’avoir fait l’honneur de participer activement à la réalisation de ce travail, Mes sincères remerciements. A Monsieur le Docteur Thibaut Lurier, De VetAgro-sup Campus Vétérinaire de Lyon, Pour m’avoir apporté votre aide précieuse, Ma sincère reconnaissance. 5 6 REMERCIEMENTS PERSONNELS A Monsieur le Docteur Hervé Morin, Directeur relations clientèle et support technique Filavie, Pour avoir rendu ce travail possible, Remerciements appuyés. Aux vétérinaires praticiens ayant participé à l’enquête, Pour leur patience, leur bienveillance et leur soutien, Mes sincères remerciements. 7 8 TABLE DES MATIERES TABLE DES ANNEXES .......................................................................................................................................... 15 TABLE DES FIGURES ........................................................................................................................................... 17 TABLE DES TABLEAUX ........................................................................................................................................ 19 LISTE DES ABREVIATIONS .................................................................................................................................. 21 INTRODUCTION ................................................................................................................................................. 23 PREMIERE PARTIE : RAPPELS D’IMMUNOLOGIE .............................................................................................. 25 I. Immunité innée et spécifique .................................................................................................................... 25 A. Immunité innée ..................................................................................................................................... 25 1. Barrières permanentes ...................................................................................................................... 25 2. Barrières inductibles .......................................................................................................................... 26 B. Immunité spécifique ou adaptative....................................................................................................... 29 1. Les cellules de l’immunité adaptative ............................................................................................... 29 2. Interactions entre CPA et LT .............................................................................................................. 31 3. Réponse immunitaire à médiation cellulaire (RIMC) ........................................................................ 31 4. Réponse immunitaire à médiation humorale ................................................................................... 32 C. Application à l’immunité antibactérienne ............................................................................................. 35 1. Immunité innée ................................................................................................................................. 35 2. Immunité adaptative ......................................................................................................................... 36 3. Mécanismes d’évasion développés par les bactéries ....................................................................... 36 II. Immunisation et vaccination ..................................................................................................................... 37 A. Immunisation passive ............................................................................................................................ 38 B. Immunisation active .............................................................................................................................. 38 1. La vaccination : définition et généralités .......................................................................................... 38 2. Propriétés du vaccin idéal ................................................................................................................. 39 3. Différents types de vaccins ................................................................................................................ 39 4. Voies d’administration ...................................................................................................................... 43 5. Vaccins multivalents et interférence vaccinale ................................................................................. 44 6. Déroulement de la réponse immunitaire post-vaccinale .................................................................. 44 7. Les adjuvants vaccinaux .................................................................................................................... 46 8. Immunité néonatale et interférence immunitaire causée par les anticorps maternels lors de la vaccination ................................................................................................................................................. 52 9. Effets secondaires liés à la vaccination ............................................................................................. 58 DEUXIEME PARTIE : LES AUTOVACCINS EN MEDECINE VETERINAIRE, REGLEMENTATION ET FABRICATION 63 I. Réglementation s’appliquant aux autovaccins en médecine vétérinaire ................................................. 63 9 A. Définition et généralités ........................................................................................................................ 63 B. Prescription ........................................................................................................................................... 63 C. Autorisation de fabrication.................................................................................................................... 64 D. Encadrement légal des pratiques de préparation ................................................................................. 64 E. Exigences en matière de pharmacovigilance pour l’établissement producteur ................................... 66 F. Particularités de la réglementation concernant les autovaccins à destination des ruminants ............ 66 1. Evolutions de la réglementation depuis 2001 ................................................................................... 66 2. Evaluation du risque de transmission du prion par les autovaccins à usage vétérinaire ................. 66 3. Particularités liées à la réautorisation des autovaccins à destination des ruminants ...................... 68 G. Exigences réglementaires s’appliquant au vétérinaire prescripteur d’autovaccins.............................. 70 H. Autres réglementations affectant le producteur d’autovaccins ........................................................... 71 I. Réglementation en vigueur dans les autres pays de l’Union Européenne............................................ 72 1. Etat des lieux des réglementations ................................................................................................... 72 2. Un changement de réglementation : vers une harmonisation ......................................................... 72 J. Cas particuliers des autovaccins viraux ................................................................................................. 73 II. Les autovaccins en médecine vétérinaire : Pourquoi et quand les utiliser ? ............................................ 74 A. Pour répondre à la raréfaction du médicament vétérinaire ................................................................. 74 B. Une solution pour lutter contre l’émergence de résistances aux antibiotiques ................................... 75 C. Dans quels cas utiliser un autovaccin ? ................................................................................................. 75 1. En cas de maladie émergente ........................................................................................................... 75 2. Lors de l’absence d’un vaccin avec AMM pour une affection mineure ou une espèce animale de destination mineure ou en cas de sérotypes multiples, lorsqu’il n’existe pas de vaccins commercialisés avec le sérotype en question ..........................................................................................
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