The world’s first multi-variant COVID-19 booster vaccine is to undergo phase 1 trials among older adults in Manchester.
The GRT-R910 vaccine, launched by US pharmaceutical company Gritstone with The University of Manchester and Manchester University NHS Foundation Trust, is said to boost the immune response of first-generation COVID-19 vaccines to a wide array of variants of Sars-Cov-2.
The phase 1 trial is being offered to 20 volunteers over the age of 60 at the National Institute for Health Research Manchester Clinical Research Facility (NIHR MCRF) at Manchester Royal Infirmary, part of Manchester University NHS Foundation Trust (MFT).
The study will examine dose, safety, tolerability, and immunogenicity of GRT-R910 at two dose levels at least four months after the second administration of their initial vaccine.
Data evaluating the vaccine is expected in the first quarter of 2022 and results from the preclinical studies leading up to the development of the vaccine will be jointly published by Gritstone and the National Institutes of Health later in the year.
GRT-R910, created as part of Gritstone’s CORAL programme, is a self-amplifying mRNA second generation SARS-CoV-2 vaccine (SAM), which delivers antigens from both the spike and non-spike proteins.
SAM vaccines work by inducing CD8+ T cells and antibodies that can neutralise the virus and prevent it binding to and infecting cells.
The researchers hope it provide robust and persistent immunity and could lead to lowering vaccine doses or eliminate the need of repeat administrations.
Dr Andrew Allen, co-founder, president and chief executive officer of Gritstone, said: “Our SAM COVID-19 vaccine is designed to drive robust CD8+ T cell responses, in addition to strong neutralising antibody responses, offering the promise of longer lasting immunity.
“Since viral surface proteins like the spike protein are evolving and sometimes partially evading vaccine-induced immunity, we designed GRT-R910 to have broad therapeutic potential against a wide array of SARS-CoV-2 variants by also delivering highly conserved viral proteins that may be less prone to genetic variation in the virus.
“Our hypothesis is that a different vaccine such as GRT-R910 might complement the primary immune response from pre-existing vaccination with a first generation COVID vaccine in such a way that it would provide more benefit than an additional dose of the same vaccine.”
Professor Andrew Ustianowski, clinical lead for the NIHR COVID Vaccine Research Programme, said: “We now know the immune response to first generation vaccines can wane, particularly in older people. Coupled with the prevalence of emerging variants, there is a clear need for continued vigilance to keep COVID-19 at bay.
“We think GRT-R910 as a booster vaccination will elicit strong, durable, and broad immune responses, which are likely to be critical in maintaining protection of this vulnerable elderly population who are particularly at risk of hospitalisation and death.”
Professor Ian Bruce, from The University of Manchester, chair of the Manchester COVID-19 Research Rapid Response Group (RRRG), added: “We’re tremendously excited that this promising vaccine is to be trialled here in Manchester. As the only European site for this study, it is testament to the way our academic and clinical researchers have come together as part of the ‘One Manchester R&I’ approach to answer the questions the world needs answers to.
“Though the vaccine is being trialled in the over 60s, future studies will also examine its efficacy in other-vulnerable populations.
“If successful, we feel it has the potential to play a significant role in the battle against COVID-19, which has so devastated vulnerable populations across the globe.”
GRT-R910 is also being investigated as part of a US National Institute of Health sponsored Phase 1 study.
Additional trials of the CORAL platform, including an additional Phase-1 trial are planned, which will inform the future development of CORAL, Gritstone’s SARS-COV-2 second generation vaccine programme.
Leave a Reply