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

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dc.contributor.authorCavaleri M
dc.contributor.authorKaslow D
dc.contributor.authorBoateng E
dc.contributor.authorChen WH
dc.contributor.authorChiu C
dc.contributor.authorChoy RKM
dc.contributor.authorCorrea-Oliveira R
dc.contributor.authorDurbin A
dc.contributor.authorEgesa M
dc.contributor.authorGibani M
dc.contributor.authorKapulu M
dc.contributor.authorKatindi M
dc.contributor.authorOlotu A
dc.contributor.authorPongsuwan P
dc.contributor.authorSimuyandi M
dc.contributor.authorSpeder B
dc.contributor.authorTalaat KR
dc.contributor.authorWeller C
dc.contributor.authorWills B
dc.contributor.authorBaay M
dc.contributor.authorBalasingam S
dc.contributor.authorOlesen OF
dc.contributor.authorNeels P
dc.date.accessioned2025-09-17T10:25:29Z
dc.date.issued2024-Feb
dc.description.abstractMany 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.
dc.identifier.doi10.1016/j.biologicals.2024.101745
dc.identifier.urihttps://pubs.cidrz.org/handle/123456789/11809
dc.identifier.uri.pubmedhttps://pubmed.ncbi.nlm.nih.gov/38341355/
dc.relation.affiliationEuropean Medicines Agency, Netherlands. Electronic address: marco.cavaleri@ema.europa.eu.
dc.relation.affiliationUS Food & Drugs Administration, USA. Electronic address: david.kaslow@fda.hhs.gov.
dc.relation.affiliationFood and Drugs Authority, Ghana. Electronic address: gus4tee@gmail.com.
dc.relation.affiliationCenter for Vaccine Development, University of Maryland School of Medicine, USA. Electronic address: wilbur.chen@som.umaryland.edu.
dc.relation.affiliationImperial College London, UK. Electronic address: c.chiu@imperial.ac.uk.
dc.relation.affiliationPATH Center for Vaccine Innovation and Access, Seattle, WA, USA. Electronic address: rchoy@path.org.
dc.relation.affiliationFundação Oswaldo Cruz (Fiocruz), Brazil.
dc.relation.affiliationJohns Hopkins Bloomberg School of Public Health, Baltimore, USA. Electronic address: adurbin1@jhu.edu.
dc.relation.affiliationMRC/UVRI and LSHTM Uganda Research Unit, Uganda; London School of Hygiene and Tropical Medicine, UK. Electronic address: Moses.Egesa@mrcuganda.org.
dc.relation.affiliationImperial College London, UK. Electronic address: m.gibani@imperial.ac.uk.
dc.relation.affiliationKEMRI-Wellcome Trust Research Programme, Kenya. Electronic address: mkapulu@kemri-wellcome.org.
dc.relation.affiliationKatindi & Company, Kenya. Electronic address: mkatindi@katindilawyers.co.ke.
dc.relation.affiliationIfakara Health Institute, Tanzania. Electronic address: aolotu@ihi.or.tz.
dc.relation.affiliationMahidol Oxford Tropical Medicine Research Unit, Bangkok, Thailand.
dc.relation.affiliationCentre for Infectious Disease Research in Zambia (CIDRZ)
dc.relation.affiliationHVIVO plc, UK. Electronic address: b.speder@hvivo.com.
dc.relation.affiliationJohns Hopkins Bloomberg School of Public Health, Baltimore, USA. Electronic address: ktalaat@jhu.edu.
dc.relation.affiliationWellcome Trust, London, UK. Electronic address: C.Weller@wellcome.org.
dc.relation.affiliationOxford University Clinical Research Unit, Ho Chi Minh City, Viet Nam. Electronic address: bwills@oucru.org.
dc.relation.affiliationP95 Epidemiology & Pharmacovigilance, Leuven, Belgium. Electronic address: marc.baay@p-95.com.
dc.relation.affiliationWellcome Trust, London, UK. Electronic address: shobana.balasingam@wellcome.org.
dc.relation.affiliationEuropean Vaccine Initiative, Heidelberg, Germany. Electronic address: ole.olesen@euvaccine.eu.
dc.relation.affiliationIABS-EU, Lyon, France. Electronic address: pieter.neels@vaccine-advice.be.
dc.sourceBiologicals : journal of the International Association of Biological Standardization
dc.titleFourth Controlled Human Infection Model (CHIM) meeting, CHIM regulatory issues, May 24, 2023.

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