Risk analysis for outpatient experimental infection as a pathway for affordable RSV vaccine development
Author(s)
Type
Journal Article
Abstract
Controlled human infection models (CHIMs) are an important tool for accelerating clinical development of vaccines. CHIM costs are driven by quarantine facilities but may be reduced by performing CHIM in the outpatient setting. Furthermore, outpatient CHIMs offer benefits beyond costs, such as a participant-friendly approach and increased real-world aspect. We analyze safety, logistic and ethical risks of respiratory syncytial virus (RSV) CHIM in the outpatient setting. A review of the literature identified outpatient CHIMs involving respiratory pathogens. RSV transmission risk was assessed using data from our inpatient and outpatient RSV CHIMs (EudraCT 020-004137-21). Fifty-nine outpatient CHIMs using RSV, Streptococcus pneumoniae, rhinovirus, and an ongoing Bordetella Pertussis outpatient CHIM were included. One transmission event was recorded. In an inpatient RSV CHIM, standard droplet and isolation measures were sufficient to limit RSV transmission and no symptomatic third-party transmission was measured in the first outpatient RSV CHIM. Logistic and ethical advantages support outpatient CHIM adoption. We propose a framework for outpatient RSV CHIM with risk mitigation strategies to enhance affordable vaccine development.
Date Issued
2025-04-15
Date Acceptance
2025-03-26
Citation
npj Vaccines, 2025, 10 (1)
ISSN
2059-0105
Publisher
Nature Portfolio
Journal / Book Title
npj Vaccines
Volume
10
Issue
1
Copyright Statement
© The Author(s) 2025. Open Access This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License, which permits any non-commercial use, sharing, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if you modified the licensed material. You do not have permission under this licence to share adapted material derived from this article or parts of it. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc-nd/4.0/
Identifier
https://www.ncbi.nlm.nih.gov/pubmed/40234435
PII: 10.1038/s41541-025-01125-w
Subjects
ADULTS
BURDEN
CHILDREN
DISEASE
EFFICACY
Immunology
Life Sciences & Biomedicine
Medicine, Research & Experimental
PHASE
Research & Experimental Medicine
RESPIRATORY SYNCYTIAL VIRUS
RHINOVIRUS
Science & Technology
SENSITIZATION
TRANSMISSION
Publication Status
Published
Coverage Spatial
England
Article Number
70
Date Publish Online
2025-04-15