SARS-CoV-2 Human Challenge Characterisation Study

Summary

This is a dose optimisation study in healthy adults aged 18-30 who will be experimentally inoculated with SARS-CoV-2. The aim is to cause PCR-confirmed upper respiratory infection in the majority of challenged individuals with minimal or no illness, providing data on the course of COVID-19 and the immune response to SARS-CoV-2 infection. This will establish an optimised dose and study design that will then be used to evaluate the efficacy of treatment and vaccine candidates plus level and duration of immune protection in follow-on trials.

Timeline

Start

2021-03-06

Primary completion

2022-07-11

Completion

2022-07-11

Publications

• Results Zhou J, Singanayagam A, Goonawardane N, Moshe M, Sweeney FP, Sukhova K, Killingley B, Kalinova M, Mann AJ, Catchpole AP, Barer MR, Ferguson NM, Chiu C, Barclay WS. Viral emissions into the air and environment after SARS-CoV-2 human challenge: a phase 1, open label, first-in-human study. Lancet Microbe. 2023 Aug;4(8):e579-e590. doi: 10.1016/S2666-5247(23)00101-5. Epub 2023 Jun 9.
• Wagstaffe HR, Thwaites RS, Sidhu JK, Lindeboom RGH, Kretschmer L, Worlock KB, Dratva LM, Huang A, Ascough S, Papargyris L, McKendry R, Collins AM, Xu J, Lemm NM, Killingley B, Kalinova M, Mann A, Catchpole A, Swadling L, Tsang JS, Maini MK, Noursadeghi M, Nikolic MZ, Teichmann SA, Openshaw PJM, Chiu C. Pre-existing and early cellular immune factors correlate with functionally complete protection against primary controlled human SARS-CoV-2 infection. Nat Commun. 2025 Dec 7;17(1):312. doi: 10.1038/s41467-025-67017-8.
• Trender W, Hellyer PJ, Killingley B, Kalinova M, Mann AJ, Catchpole AP, Menon D, Needham E, Thwaites R, Chiu C, Scott G, Hampshire A. Changes in memory and cognition during the SARS-CoV-2 human challenge study. EClinicalMedicine. 2024 Sep 21;76:102842. doi: 10.1016/j.eclinm.2024.102842. eCollection 2024 Oct.
• Lindeboom RGH, Worlock KB, Dratva LM, Yoshida M, Scobie D, Wagstaffe HR, Richardson L, Wilbrey-Clark A, Barnes JL, Kretschmer L, Polanski K, Allen-Hyttinen J, Mehta P, Sumanaweera D, Boccacino JM, Sungnak W, Elmentaite R, Huang N, Mamanova L, Kapuge R, Bolt L, Prigmore E, Killingley B, Kalinova M, Mayer M, Boyers A, Mann A, Swadling L, Woodall MNJ, Ellis S, Smith CM, Teixeira VH, Janes SM, Chambers RC, Haniffa M, Catchpole A, Heyderman R, Noursadeghi M, Chain B, Mayer A, Meyer KB, Chiu C, Nikolic MZ, Teichmann SA. Human SARS-CoV-2 challenge uncovers local and systemic response dynamics. Nature. 2024 Jul;631(8019):189-198. doi: 10.1038/s41586-024-07575-x. Epub 2024 Jun 19.
• Killingley B, Mann AJ, Kalinova M, Boyers A, Goonawardane N, Zhou J, Lindsell K, Hare SS, Brown J, Frise R, Smith E, Hopkins C, Noulin N, Londt B, Wilkinson T, Harden S, McShane H, Baillet M, Gilbert A, Jacobs M, Charman C, Mande P, Nguyen-Van-Tam JS, Semple MG, Read RC, Ferguson NM, Openshaw PJ, Rapeport G, Barclay WS, Catchpole AP, Chiu C. Safety, tolerability and viral kinetics during SARS-CoV-2 human challenge in young adults. Nat Med. 2022 May;28(5):1031-1041. doi: 10.1038/s41591-022-01780-9. Epub 2022 Mar 31.

Drugs

Indications