Risk analysis for outpatient experimental infection as a pathway for affordable RSV vaccine development

E Z Siegal; J M H Schoevers; J Terstappen; E M Delemarre; S L Johnston; L F van Beek; D Bogaert; C Chiu; D A Diavatopoulos; D M Ferreira; S B Gordon; F G Hayden; M I de Jonge; M B B McCall; H I McShane; A M Minassian; P J M Openshaw; A J Pollard; J Sattabongkot; R C Read; A Troelstra; M C Viveen; A Wilder-Smith; M van Wijk; L J Bont; N I Mazur

doi:10.1038/s41541-025-01125-w

Risk analysis for outpatient experimental infection as a pathway for affordable RSV vaccine development

E Z Siegal, J M H Schoevers, J Terstappen, E M Delemarre, S L Johnston, L F van Beek, D Bogaert, C Chiu, D A Diavatopoulos, D M Ferreira, S B Gordon, F G Hayden, M I de Jonge, M B B McCall, H I McShane, A M Minassian, P J M Openshaw, A J Pollard, J Sattabongkot, R C ReadA Troelstra, M C Viveen, A Wilder-Smith, M van Wijk, L J Bont, N I Mazur^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

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.

Original language	English
Article number	70
Number of pages	9
Journal	npj Vaccines
Volume	10
Issue number	1
DOIs	https://doi.org/10.1038/s41541-025-01125-w
Publication status	Published - 15 Apr 2025

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s41541-025-01125-wFinal published version, 1.19 MBLicence: CC BY-NC-ND

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Siegal, E. Z., Schoevers, J. M. H., Terstappen, J., Delemarre, E. M., Johnston, S. L., van Beek, L. F., Bogaert, D., Chiu, C., Diavatopoulos, D. A., Ferreira, D. M., Gordon, S. B., Hayden, F. G., de Jonge, M. I., McCall, M. B. B., McShane, H. I., Minassian, A. M., Openshaw, P. J. M., Pollard, A. J., Sattabongkot, J., ... Mazur, N. I. (2025). Risk analysis for outpatient experimental infection as a pathway for affordable RSV vaccine development. npj Vaccines, 10(1), Article 70. https://doi.org/10.1038/s41541-025-01125-w

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title = "Risk analysis for outpatient experimental infection as a pathway for affordable RSV vaccine development",

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.",

author = "Siegal, {E Z} and Schoevers, {J M H} and J Terstappen and Delemarre, {E M} and Johnston, {S L} and {van Beek}, {L F} and D Bogaert and C Chiu and Diavatopoulos, {D A} and Ferreira, {D M} and Gordon, {S B} and Hayden, {F G} and {de Jonge}, {M I} and McCall, {M B B} and McShane, {H I} and Minassian, {A M} and Openshaw, {P J M} and Pollard, {A J} and J Sattabongkot and Read, {R C} and A Troelstra and Viveen, {M C} and A Wilder-Smith and {van Wijk}, M and Bont, {L J} and Mazur, {N I}",

note = "Publisher Copyright: {\textcopyright} The Author(s) 2025.",

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Siegal, EZ, Schoevers, JMH, Terstappen, J, Delemarre, EM, Johnston, SL, van Beek, LF, Bogaert, D, Chiu, C, Diavatopoulos, DA, Ferreira, DM, Gordon, SB, Hayden, FG, de Jonge, MI, McCall, MBB, McShane, HI, Minassian, AM, Openshaw, PJM, Pollard, AJ, Sattabongkot, J, Read, RC, Troelstra, A, Viveen, MC, Wilder-Smith, A, van Wijk, M, Bont, LJ & Mazur, NI 2025, 'Risk analysis for outpatient experimental infection as a pathway for affordable RSV vaccine development', npj Vaccines, vol. 10, no. 1, 70. https://doi.org/10.1038/s41541-025-01125-w

TY - JOUR

T1 - Risk analysis for outpatient experimental infection as a pathway for affordable RSV vaccine development

AU - Siegal, E Z

AU - Schoevers, J M H

AU - Terstappen, J

AU - Delemarre, E M

AU - Johnston, S L

AU - van Beek, L F

AU - Bogaert, D

AU - Chiu, C

AU - Diavatopoulos, D A

AU - Ferreira, D M

AU - Gordon, S B

AU - Hayden, F G

AU - de Jonge, M I

AU - McCall, M B B

AU - McShane, H I

AU - Minassian, A M

AU - Openshaw, P J M

AU - Pollard, A J

AU - Sattabongkot, J

AU - Read, R C

AU - Troelstra, A

AU - Viveen, M C

AU - Wilder-Smith, A

AU - van Wijk, M

AU - Bont, L J

AU - Mazur, N I

PY - 2025/4/15

Y1 - 2025/4/15

N2 - 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.

AB - 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.

U2 - 10.1038/s41541-025-01125-w

DO - 10.1038/s41541-025-01125-w

M3 - Article

C2 - 40234435

VL - 10

JO - npj Vaccines

JF - npj Vaccines

IS - 1

M1 - 70

ER -

Risk analysis for outpatient experimental infection as a pathway for affordable RSV vaccine development

Abstract

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