hVIVO used Nuvonis’ GMP Vero cells to produce Novel SARS-CoV-2 virus for a human challenge model
A case example from one of our customers, hVIVO:
- First contact with Nuvonis in July 2020, due diligence, contracting, provision of GMP Vero cells and protocols, as well as full documentation
- Production of GMP material in November 2020
- Clinical trial study started in March 2021
- First publication of the data in early 2022
UK-based hVIVO Services Limited produced two different viral strains of SARS-CoV-2 in Nuvonis’ Vero cells under GMP conditions, a Wuhan-like D614G virus and a Delta strain.
This virus was used as a challenge virus in a human viral challenge study in healthy adults in the UK, which was initiated in 2021 and is ongoing, currently with the subjects in the follow-up phase.
Further challenge studies are underway, in which previously infected and vaccinated volunteers will be challenged with escalating inoculum doses (ClinicalTrials.gov identifier NCT04864548) and/or viral variants to investigate the interplay between virus and host factors that influence clinical outcome. First publication of the data from the study was published earlier this year in Nature Medicin
These studies will optimise the platform for potential use in the rapid evaluation of vaccines, antivirals and diagnostics by generating efficacy data early during clinical development and avoiding the uncertainties of studies that require ongoing community transmission.
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