Risk analysis for outpatient experimental infection as a pathway for affordable RSV vaccine development
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.
Authors
- Lucille F. van Beek (ORCID: https://orcid.org/0000-0002-7126-2580)
- Annellies Wilder-Smith
- Stephen B. Gordon (ORCID: https://orcid.org/0000-0001-6576-1116)
- Peter Openshaw (ORCID: https://orcid.org/0000-0002-7220-2555)
- Christopher Chiu (ORCID: https://orcid.org/0000-0003-0914-920X)
- Debby Bogaert (ORCID: https://orcid.org/0000-0003-2651-7000)
- Natalie I Mazur (ORCID: https://orcid.org/0000-0002-3233-908X)
- Eveline M. Delemarre (ORCID: https://orcid.org/0000-0002-4310-0998)
- Matthew B. B. McCall (ORCID: https://orcid.org/0000-0002-5738-1401)
- Jetsumon Sattabongkot (ORCID: https://orcid.org/0000-0002-3938-4588)
- Louis Bont (ORCID: https://orcid.org/0000-0003-3099-4475)
- Jonne Terstappen (ORCID: https://orcid.org/0000-0003-2986-0138)
- Daniela M. Ferreira (ORCID: https://orcid.org/0000-0002-0594-0902)
- Michiel P. van Wijk (ORCID: https://orcid.org/0000-0002-8112-8414)
- Sebastian Lennox Johnston (ORCID: https://orcid.org/0000-0003-3009-9200)
- Frederick G. Hayden (ORCID: https://orcid.org/0000-0001-8707-0375)
- Angela M. Minassian (ORCID: https://orcid.org/0000-0001-7832-9824)
- Annet Troelstra
- Andrew J. Pollard (ORCID: https://orcid.org/0000-0001-7361-719X)
- Marien Isaäk de Jonge (ORCID: https://orcid.org/0000-0003-2812-5895)
- Dimitri A. Diavatopoulos (ORCID: https://orcid.org/0000-0001-7065-7807)
- Helen McShane (ORCID: https://orcid.org/0000-0002-2126-5142)
- Robert C. Read (ORCID: https://orcid.org/0000-0002-4297-6728)
- Marco C. Viveen
- E Z Siegal
- J M H Schoevers
Institutions
- Radboud University Nijmegen (NL)
- Liverpool School of Tropical Medicine (GB)
- Heidelberg University (DE)
- Mahidol University (TH)
- University of Virginia Health System (US)
- Global Virus Network (US)
- University Hospital Heidelberg (DE)
- Radboud University Medical Center (NL)
- University Medical Center Utrecht (NL)
- University of Oxford (GB)
- St. Antonius Ziekenhuis (NL)
- Radboud Institute for Molecular Life Sciences (NL)
- Oxford BioMedica (United Kingdom) (GB)
- Centre for Inflammation Research (GB)
- Wilhelmina Children's Hospital (NL)
- University of Southampton (GB)
- Imperial College London (GB)
- University of Virginia (US)
- University of Edinburgh (GB)
Publication Details
- Journal
- npj Vaccines
- Published
- 2025-04-15
- DOI
- https://doi.org/10.1038/s41541-025-01125-w
- Citations
- 1
- Primary Topic
- Respiratory viral infections research
- Type
- article
- Field-Weighted Citation Impact
- 1.35
Funders
- Lung Foundation Netherlands