Biotechnology company Gritstone bio, Inc. (GRTS) announced Monday that the first volunteer has been dosed in a Phase 1 trial evaluating the ability of GRT-R910, a self-amplifying mRNA (SAM) second generation SARS-CoV-2 vaccine to boost and expand the immunogenicity of first-generation COVID-19 vaccines in subjects 60 years of age or older.
This single-center study is being conducted in collaboration with The University of Manchester and Manchester University NHS Foundation Trust in the United Kingdom.
The Gritstone sponsored Phase 1 trial, which is initially expected to enroll 20 volunteers, will explore the ability of GRT-R910 to boost and expand the immunogenicity of AstraZeneca's first-generation COVID-19 vaccine AZD1222 (Vaxzevria) in healthy adults = 60 years.
This open-label dose-escalation design study will examine dose, safety, tolerability, and immunogenicity of GRT-R910 at two dose levels at least 4 months after the second administration of their initial vaccine.
GRT-R910 is part of Gritstone's CORAL program, a second-generation COVID-19 vaccine platform that uses a SAM vector formulated with lipid nanoparticles to deliver a broad set of antigens against SARS-CoV-2 that includes both stabilized spike protein and highly conserved viral protein regions containing T cell epitopes.
By virtue of self-amplification, extended duration and magnitude of antigen production with SAM vaccines may offer the opportunity of lowering vaccine doses or eliminate the need for repeat administrations. It also has potential to safely elicit strong, durable and broad immune responses across SARS-CoV-2 variants.
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