Fourth Controlled Human Infection Model (CHIM) meeting, CHIM regulatory issues, May 24, 2023

• Published in: Biologicals 2024-02, Vol.85, p.101745, Article 101745
• Main Authors: Cavaleri, Marco, Kaslow, David, Boateng, Eric, Chen, Wilbur H., Chiu, Christopher, Choy, Robert K.M., Correa-Oliveira, Rodrigo, Durbin, Anna, Egesa, Moses, Gibani, Malick, Kapulu, Melissa, Katindi, Melba, Olotu, Ally, Pongsuwan, Pongphaya, Simuyandi, Michelo, Speder, Bruno, Talaat, Kawsar R., Weller, Charlie, Wills, Bridget, Baay, Marc, Balasingam, Shobana, Olesen, Ole F., Neels, Pieter
• Format: Article
• Language: English
• Subjects: Deliberate infection; Human challenge; Infectious diseases; Low- and middle-income countries; Vaccine
• ISSN: 1045-1056; 1095-8320; 1095-8320
• DOI: 10.1016/j.biologicals.2024.101745

Many aspects of Controlled Human Infection Models (CHIMs, also known as human challenge studies and human infection studies) have been discussed extensively, 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 regulation of CHIM studies, bringing together scientists and regulators from high-, middle-, and low-income countries, to discuss barriers and hurdles in CHIM regulation. Valuable initiatives for regulation of CHIMs have already been undertaken but further capacity building remains essential. The Wellcome Considerations document is a good starting point for further discussions. •The time is right to discuss the regulation of first-in-human studies, including CHIM studies, in LMIC.•The biggest remaining hurdle in many countries is the lack of a regulatory framework for conducting CHIM studies.•Currently, CHIM studies should not be performed in children, except when using an approved, live-attenuated vaccines.•Engagement should include regulators, health care professionals, potential study participants, and the community.•CHIMs could establish vaccine effect on reducing pathogen shedding and transmission not readily established in field trials.