Melissa Kapulu , Lucinda Manda-Taylor , Shobana Balasingam , Gary Means , Mikal Ayiro Malungu , Philip Bejon , Primus Che Chi , Christopher Chiu , E. Chandler Church , Rodrigo Correa-Oliveira , Nicholas Day , Anna Durbin , Moses Egesa , Claudia Emerson , Kondwani Jambo , Roli Mathur , Wolfram Metzger , Noni Mumba , Winfred Nazziwa , Ally Olotu , Pieter Neels
{"title":"第四次人类感染控制模型(CHIM)会议--流行国家的人类感染控制模型,2023 年 5 月 22-23 日。","authors":"Melissa Kapulu , Lucinda Manda-Taylor , Shobana Balasingam , Gary Means , Mikal Ayiro Malungu , Philip Bejon , Primus Che Chi , Christopher Chiu , E. Chandler Church , Rodrigo Correa-Oliveira , Nicholas Day , Anna Durbin , Moses Egesa , Claudia Emerson , Kondwani Jambo , Roli Mathur , Wolfram Metzger , Noni Mumba , Winfred Nazziwa , Ally Olotu , Pieter Neels","doi":"10.1016/j.biologicals.2024.101747","DOIUrl":null,"url":null,"abstract":"<div><p>Earlier meetings laid the foundations for Controlled Human Infection Models (CHIMs), also known as human challenge studies and human infection studies, including Good Manufacturing Practice (GMP) production of the challenge agent, CHIM ethics, environmental safety in CHIM, recruitment, community engagement, advertising and incentives, pre-existing immunity, and clinical, immunological, and microbiological endpoints. The fourth CHIM meeting focused on CHIM studies being conducted in endemic countries. Over the last ten years we have seen a vast expansion of the number of countries in Africa performing CHIM studies, as well as a growing number of different challenge organisms being used. Community and public engagement with assiduous ethical and regulatory oversight has been central to successful introductions and should be continued, in more community-led or community-driven models. Valuable initiatives for regulation of CHIMs have been undertaken but further capacity building remains essential.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"85 ","pages":"Article 101747"},"PeriodicalIF":1.5000,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1045105624000046/pdfft?md5=440fe4e1d3cece54f9e77639d77e127c&pid=1-s2.0-S1045105624000046-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Fourth Controlled Human Infection Model (CHIM) meeting – CHIMs in endemic countries, May 22–23, 2023\",\"authors\":\"Melissa Kapulu , Lucinda Manda-Taylor , Shobana Balasingam , Gary Means , Mikal Ayiro Malungu , Philip Bejon , Primus Che Chi , Christopher Chiu , E. Chandler Church , Rodrigo Correa-Oliveira , Nicholas Day , Anna Durbin , Moses Egesa , Claudia Emerson , Kondwani Jambo , Roli Mathur , Wolfram Metzger , Noni Mumba , Winfred Nazziwa , Ally Olotu , Pieter Neels\",\"doi\":\"10.1016/j.biologicals.2024.101747\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><p>Earlier meetings laid the foundations for Controlled Human Infection Models (CHIMs), also known as human challenge studies and human infection studies, including Good Manufacturing Practice (GMP) production of the challenge agent, CHIM ethics, environmental safety in CHIM, recruitment, community engagement, advertising and incentives, pre-existing immunity, and clinical, immunological, and microbiological endpoints. The fourth CHIM meeting focused on CHIM studies being conducted in endemic countries. Over the last ten years we have seen a vast expansion of the number of countries in Africa performing CHIM studies, as well as a growing number of different challenge organisms being used. Community and public engagement with assiduous ethical and regulatory oversight has been central to successful introductions and should be continued, in more community-led or community-driven models. Valuable initiatives for regulation of CHIMs have been undertaken but further capacity building remains essential.</p></div>\",\"PeriodicalId\":55369,\"journal\":{\"name\":\"Biologicals\",\"volume\":\"85 \",\"pages\":\"Article 101747\"},\"PeriodicalIF\":1.5000,\"publicationDate\":\"2024-02-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S1045105624000046/pdfft?md5=440fe4e1d3cece54f9e77639d77e127c&pid=1-s2.0-S1045105624000046-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Biologicals\",\"FirstCategoryId\":\"99\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1045105624000046\",\"RegionNum\":4,\"RegionCategory\":\"生物学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/2/13 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q4\",\"JCRName\":\"BIOCHEMICAL RESEARCH METHODS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Biologicals","FirstCategoryId":"99","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1045105624000046","RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/2/13 0:00:00","PubModel":"Epub","JCR":"Q4","JCRName":"BIOCHEMICAL RESEARCH METHODS","Score":null,"Total":0}
Fourth Controlled Human Infection Model (CHIM) meeting – CHIMs in endemic countries, May 22–23, 2023
Earlier meetings laid the foundations for Controlled Human Infection Models (CHIMs), also known as human challenge studies and human infection studies, including Good Manufacturing Practice (GMP) production of the challenge agent, CHIM ethics, environmental safety in CHIM, recruitment, community engagement, advertising and incentives, pre-existing immunity, and clinical, immunological, and microbiological endpoints. The fourth CHIM meeting focused on CHIM studies being conducted in endemic countries. Over the last ten years we have seen a vast expansion of the number of countries in Africa performing CHIM studies, as well as a growing number of different challenge organisms being used. Community and public engagement with assiduous ethical and regulatory oversight has been central to successful introductions and should be continued, in more community-led or community-driven models. Valuable initiatives for regulation of CHIMs have been undertaken but further capacity building remains essential.
期刊介绍:
Biologicals provides a modern and multidisciplinary international forum for news, debate, and original research on all aspects of biologicals used in human and veterinary medicine. The journal publishes original papers, reviews, and letters relevant to the development, production, quality control, and standardization of biological derived from both novel and established biotechnologies. Special issues are produced to reflect topics of particular international interest and concern.Three types of papers are welcome: original research reports, short papers, and review articles. The journal will also publish comments and letters to the editor, book reviews, meeting reports and information on regulatory issues.