{"id":13457,"date":"2023-03-10T15:58:29","date_gmt":"2023-03-10T12:58:29","guid":{"rendered":"https:\/\/www.pasteur.mg\/?p=13457"},"modified":"2025-06-26T10:43:38","modified_gmt":"2025-06-26T07:43:38","slug":"visites-des-sites-de-lessai-clinique-du-projet-mtbvacn3-a-madagascar","status":"publish","type":"post","link":"https:\/\/www.pasteur.mg\/en\/visites-des-sites-de-lessai-clinique-du-projet-mtbvacn3-a-madagascar\/","title":{"rendered":"Visites des sites de l\u2019essai clinique du projet MTBVACN3 \u00e0 Madagascar"},"content":{"rendered":"
\"\"

L\u2019\u00e9quipe du CHUGOB, de l\u2019IPM et les repr\u00e9sentants du FHI Clinical<\/p><\/div>\n

L\u2019Institut Pasteur de Madagascar a organis\u00e9 les 8 et 9 mars 2023, deux r\u00e9unions dans le cadre de la visite de mise en place du projet \u00ab \u00c9valuation de l\u2019innocuit\u00e9 et de l\u2019immunog\u00e9nicit\u00e9 du vaccin MTBVAC par rapport au BCG chez les nouveau-n\u00e9s \u00e0 Madagascar (MTBVACN3) \u00bb.<\/p>\n

Il s’agit d’un projet multicentrique, regroupant plusieurs institutions en Europe (Espagne, Pays-Bas) et en Afrique subsaharienne (Afrique du Sud, S\u00e9n\u00e9gal et Madagascar). Pour Madagascar ce projet est men\u00e9 par l\u2019Unit\u00e9 des Mycobact\u00e9ries et l\u2019Unit\u00e9 d\u2019\u00c9pid\u00e9miologie et de Recherche Clinique \u00e0 l\u2019IPM, en collaboration avec le Centre Hospitalier Universitaire de Gyn\u00e9cologie-Obst\u00e9trique Befelatanana \u00e0 Antananarivo, la Direction du Programme \u00c9largi de Vaccination \u00e0 Antananarivo.<\/p>\n

Financ\u00e9 par l\u2019European & Developing Countries Clinical Trials Partnership (EDCTP1<\/sup>) et par Biofabri (Espagne) qui coordonne tout le projet, ce projet a pour objectif d\u2019\u00e9valuer l’innocuit\u00e9 et l’immunog\u00e9nicit\u00e9 d\u2019un candidat vaccin contre la tuberculose (Mycobacterium tuberculosis<\/em> Vaccine ou MTBVAC) chez les nouveau-n\u00e9s sains dans une cohorte non expos\u00e9e au VIH par comparaison \u00e0 l\u2019administration du BCG \u00e0 Madagascar.<\/p>\n

Pour la mise en place (dite \u00ab visite d\u2019initiation de site \u00bb) de ce projet \u00e0 Madagascar, deux visites des sites de l\u2019essai ont eu lieu, le 8 mars \u00e0 l\u2019Unit\u00e9 des Mycobact\u00e9ries \u00e0 l\u2019IPM, les 9 et 10 mars 2023 au Centre Hospitalier Universitaire de Gyn\u00e9cologie et Obst\u00e9trique Befelatanana (CHUGOB). Ces visites d’initiation de site marquent le d\u00e9but de l’essai clinique afin de s’assurer que le site est pr\u00eat \u00e0 commencer \u00e0 recruter des sujets.<\/p>\n

 <\/p>\n

\"\"

Visite \u00e0 l’IPM<\/p><\/div>\n

\u00ab\u00a0Le projet MTBVACN3 entre dans les principales missions du CHUGOB, car c\u2019est avant tout de la recherche. De plus, la maternit\u00e9 enregistre un nombre consid\u00e9rable de naissances qui permettra d\u2019atteindre facilement l\u2019objectif de l\u2019\u00e9tude de ce nouveau vaccin contre la tuberculose\u00a0\u00bb<\/em>, a d\u00e9clar\u00e9 Dr RABEMANANA Dominique Marie G\u00e9rard, Directeur Adjoint Technique du CHUGOB.<\/p>\n

Ces visites se sont d\u00e9roul\u00e9es en pr\u00e9sence des responsables du projet \u00e0 l\u2019IPM et des repr\u00e9sentants de l\u2019\u00e9quipe de FHI Clinical Afrique du Sud.<\/p>\n

La premi\u00e8re journ\u00e9e a \u00e9t\u00e9 consacr\u00e9e \u00e0 la visite du laboratoire et de ses installations respectant la r\u00e9glementation en vigueur, le protocole approuv\u00e9 par le Comit\u00e9 d\u2019Ethique de la Recherche Biom\u00e9dicale du Minist\u00e8re de la Sant\u00e9 Publique et les bonnes pratiques cliniques. La deuxi\u00e8me journ\u00e9e s\u2019est d\u00e9roul\u00e9e au CHU, site de recrutement des candidats pour cet essai clinique.<\/p>\n

La r\u00e9alisation de cet essai vise \u00e0 d\u00e9montrer une innocuit\u00e9 et une efficacit\u00e9 meilleures que celles du BCG, chez les nouveau-n\u00e9s dans les pays \u00e0 forte end\u00e9mie de tuberculose. De fa\u00e7on g\u00e9n\u00e9rale, ce projet permettra de faire avancer la recherche de vaccins plus efficaces contre la tuberculose.<\/p>\n

\u00ab\u00a0Pour un bon suivi de l\u2019efficacit\u00e9 de ce vaccin, les p\u00e9diatres du CHUGOB feront un suivi de la sant\u00e9 des b\u00e9b\u00e9s durant leur premi\u00e8re ann\u00e9e de vie\u00a0\u00bb,<\/em> souligne Dr RAJAONARISON Hery, p\u00e9diatre au CHUGOB.<\/p>\n

\"\"<\/p>\n

\"\"

R\u00e9union avec l\u2019\u00e9quipe du CHUGOB<\/p><\/div>\n

[1] Ce communiqu\u00e9 a \u00e9t\u00e9 produit par MTBVACN3 qui fait partie du programme EDCTP2 soutenu par l’Union europ\u00e9enne (num\u00e9ro de subvention RIA2019S-2652-MTBVACN3). Les points de vue et opinions des auteurs exprim\u00e9s ici n’indiquent pas ou ne refl\u00e8tent pas n\u00e9cessairement celles de l’EDCTP.<\/em><\/p>","protected":false},"excerpt":{"rendered":"

L\u2019Institut Pasteur de Madagascar a organis\u00e9 les 8 et 9 mars 2023, deux r\u00e9unions dans le cadre de la visite de mise en place du projet \u00ab \u00c9valuation de l\u2019innocuit\u00e9 et de l\u2019immunog\u00e9nicit\u00e9 du vaccin MTBVAC par rapport au BCG chez les nouveau-n\u00e9s \u00e0 Madagascar (MTBVACN3) \u00bb. Il s’agit d’un projet multicentrique, regroupant plusieurs institutions […]<\/p>","protected":false},"author":9,"featured_media":13458,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_post_was_ever_published":false},"categories":[730,629],"tags":[],"class_list":["post-13457","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sante-mere-et-enfant","category-tuberculose"],"acf":[],"yoast_head":"\nVisites des sites de l\u2019essai clinique du projet MTBVACN3 \u00e0 Madagascar - Institut Pasteur de Madagascar<\/title>\n<meta name=\"description\" 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