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

Marco Cavaleri; David Kaslow; Eric Boateng; Wilbur H Chen; Christopher Chiu; Robert K M Choy; Rodrigo Correa-Oliveira; Anna Durbin; Moses Egesa; Malick Gibani; Melissa Kapulu; Melba Katindi; Ally Olotu; Pongphaya Pongsuwan; Michelo Simuyandi; Bruno Speder; Kawsar R Talaat; Charlie Weller; Bridget Wills; Marc Baay; Shobana Balasingam; Ole F Olesen; Pieter Neels

doi:10.1016/j.biologicals.2024.101745

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

Biologicals. 2024 Feb:85:101745. doi: 10.1016/j.biologicals.2024.101745. Epub 2024 Feb 10.

Authors

Marco Cavaleri¹, David Kaslow², Eric Boateng³, Wilbur H Chen⁴, Christopher Chiu⁵, Robert K M Choy⁶, Rodrigo Correa-Oliveira⁷, Anna Durbin⁸, Moses Egesa⁹, Malick Gibani¹⁰, Melissa Kapulu¹¹, Melba Katindi¹², Ally Olotu¹³, Pongphaya Pongsuwan¹⁴, Michelo Simuyandi¹⁵, Bruno Speder¹⁶, Kawsar R Talaat¹⁷, Charlie Weller¹⁸, Bridget Wills¹⁹, Marc Baay²⁰, Shobana Balasingam²¹, Ole F Olesen²², Pieter Neels²³

Affiliations

¹ European Medicines Agency, Netherlands. Electronic address: [email protected].
² US Food & Drugs Administration, USA. Electronic address: [email protected].
³ Food and Drugs Authority, Ghana. Electronic address: [email protected].
⁴ Center for Vaccine Development, University of Maryland School of Medicine, USA. Electronic address: [email protected].
⁵ Imperial College London, UK. Electronic address: [email protected].
⁶ PATH Center for Vaccine Innovation and Access, Seattle, WA, USA. Electronic address: [email protected].
⁷ Fundação Oswaldo Cruz (Fiocruz), Brazil.
⁸ Johns Hopkins Bloomberg School of Public Health, Baltimore, USA. Electronic address: [email protected].
⁹ MRC/UVRI and LSHTM Uganda Research Unit, Uganda; London School of Hygiene and Tropical Medicine, UK. Electronic address: [email protected].
¹⁰ Imperial College London, UK. Electronic address: [email protected].
¹¹ KEMRI-Wellcome Trust Research Programme, Kenya. Electronic address: [email protected].
¹² Katindi & Company, Kenya. Electronic address: [email protected].
¹³ Ifakara Health Institute, Tanzania. Electronic address: [email protected].
¹⁴ Mahidol Oxford Tropical Medicine Research Unit, Bangkok, Thailand.
¹⁵ Centre for Infectious Disease Research, Zambia. Electronic address: [email protected].
¹⁶ HVIVO plc, UK. Electronic address: [email protected].
¹⁷ Johns Hopkins Bloomberg School of Public Health, Baltimore, USA. Electronic address: [email protected].
¹⁸ Wellcome Trust, London, UK. Electronic address: [email protected].
¹⁹ Oxford University Clinical Research Unit, Ho Chi Minh City, Viet Nam. Electronic address: [email protected].
²⁰ P95 Epidemiology & Pharmacovigilance, Leuven, Belgium. Electronic address: [email protected].
²¹ Wellcome Trust, London, UK. Electronic address: [email protected].
²² European Vaccine Initiative, Heidelberg, Germany. Electronic address: [email protected].
²³ IABS-EU, Lyon, France. Electronic address: [email protected].

Abstract

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.

Keywords: Deliberate infection; Human challenge; Infectious diseases; Low- and middle-income countries; Vaccine.

Abstract

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