Fourth Controlled Human Infection Model (CHIM) meeting – CHIMs in endemic countries, May 22–23, 2023

• Published in: Biologicals Vol. 85; p. 101747
• Main Authors: Kapulu, Melissa, Manda-Taylor, Lucinda, Balasingam, Shobana, Means, Gary, Ayiro Malungu, Mikal, Bejon, Philip, Chi, Primus Che, Chiu, Christopher, Church, E. Chandler, Correa-Oliveira, Rodrigo, Day, Nicholas, Durbin, Anna, Egesa, Moses, Emerson, Claudia, Jambo, Kondwani, Mathur, Roli, Metzger, Wolfram, Mumba, Noni, Nazziwa, Winfred, Olotu, Ally, Rodgers, Jacqueline, Sinyiza, Frank, Talaat, Kawsar, Kamerling, Ingrid, Weller, Charlie, Baay, Marc, Neels, Pieter
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01.02.2024
• Subjects: Deliberate infection; Endemic diseases; Human challenge; Human infection studies; Infectious diseases; Low- and middle-income countries; Vaccine; Deliberate infection; Infectious diseases; Low- and middle-income countries; Human challenge; Vaccine; Endemic diseases; Human infection studies
• ISSN: 1045-1056; 1095-8320; 1095-8320
• DOI: 10.1016/j.biologicals.2024.101747

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. •High background immunity in endemic settings (often in LMICs) can impact vaccine efficacy.•Establishing CHIM in endemic settings would allow for vaccines to be tailored for those populations most in need.•The different CHIMs show many commonalities but also pathogen-specific issues.•CHIM studies are multidisciplinary, requiring extensive coordination and engagement.•Work on guiding principles needs to be continual and evolve to reflect new insights.