Completed Infection & Immunity Lungs & Breathing

Manufacture of a GMP SARS-CoV-2 challenge agent

Funder Wellcome Charity-funded
Associated organisations Imperial College London · University of Oxford Europe PMC affiliations are not treated as award recipients or mapped locations.
Funding £4.2M
Period Apr 2021 — Jul 2023

In plain English

AI plain-English summary

Healthy volunteers will be deliberately infected with SARS-CoV-2 to test how well vaccines work. This is a dose-finding study to produce two standardised virus batches that can safely infect the upper respiratory tract of young, healthy people. The problem is that during lulls between pandemic waves, natural infections become too rare to test vaccines quickly. Field trials require thousands of participants and months of waiting for enough people to catch the virus in the community. A controlled human infection model—where volunteers are intentionally exposed—can deliver answers in weeks with far fewer participants. If this succeeds, the model will allow rapid comparison of vaccine candidates, identifying the most promising ones for large-scale deployment. It can also reveal how long protection lasts in people who have already had COVID-19, and uncover the immune mechanisms that prevent infection or reduce viral shedding. This would accelerate vaccine selection and help public health agencies make faster, evidence-based decisions during future outbreaks. The work is directly applied—its entire purpose is to speed up practical vaccine testing.

View original technical description
In the current COVID-19 emergency, a controlled SARS-COV-2 human infection model (CHIM) has the potential to accelerate the understanding of pathogenesis, induction of immunity and immune mechanisms of resistance to disease, as well as a means to test novel diagnostics and treatments, especially between waves of the pandemic, when occurrence of natural disease is relatively uncommon. A large number of SARS-COV-2 vaccine candidates are at various stages of development internationally including those which have recently entered mid-late stage clinical testing in field studies. In order to make the greatest public health impact, there is an urgent need to select the most promising vaccines in the shortest possible timeframe. In addition, human infection challenge can contribute to the identification of correlates and mechanisms of protection against infection and shedding of virus in vaccinated volunteers. Finally, the model may be useful in the determination of the durability of protection in seropositive individuals with documented prior wild type infection. This proposal is a dose titration study to generate two GMP challenge agents and establish the safety of a wild-type SARS-COV-2 controlled infection in the upper respiratory tract of young healthy volunteers that will allow swift and robust assessment of vaccine efficacy.

View the original record at the funder ↗

Researchers

Christopher Chiu (EPMC Awardee)Helen McShane (EPMC Awardee)Peter Openshaw (EPMC Awardee)Wendy Barclay (EPMC Awardee)

Related Research

Grants with similar aims, by meaning.

Characterisation of a GMP SARS-CoV-2 Delta variant for human challenge
Defining the Protective Immune Response to SARS-CoV-2 Using a Human Challenge Model
A dose finding human experimental infection study with SARS-CoV-2 in healthy volunteers immunologically sensitised with either previous, microbiologically confirmed, SARS-CoV-2 infection and/or vaccination against SARS-CoV-2
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Development of a SARS-CoV-2 Delta variant human infection challenge model (COVHIC002)

Original classification

Human Infection Studies (Full)

Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.