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A Company-Sponsored COVID-19 Clinical Study Evaluating a Novel Vaccine Containing Spike and Other SARS-CoV-2 Epitopes as a Boost after First Generation Vaccination (CORAL as a Boost Vaccine Following Vaccination)

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Trial Profile

A Company-Sponsored COVID-19 Clinical Study Evaluating a Novel Vaccine Containing Spike and Other SARS-CoV-2 Epitopes as a Boost after First Generation Vaccination (CORAL as a Boost Vaccine Following Vaccination)

Status: Planning
Phase of Trial: Phase II

Latest Information Update: 07 Mar 2024

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At a glance

  • Drugs COVID-19 vaccines-Gritstone bio (Primary)
  • Indications COVID 2019 infections
  • Focus Therapeutic Use
  • Acronyms CORAL-BARDA
  • Sponsors Gritstone bio
  • Most Recent Events

    • 05 Mar 2024 According to a Gritstone bio media release, in February 2024, the company announced it will incorporate GMP-grade materials in the manufacture of its self-amplifying mRNA (samRNA) candidate, resulting in a delay of the CORAL-BARDA. The move is expected to increase the regulatory utility of the anticipated 10,000 subject, comparative Phase 2b study contracted by the Biomedical Advanced Research and Development Authority (BARDA). Gritstone is now preparing to launch the study in fall of 2024.
    • 29 Feb 2024 According to a Gritstone bio media release, company announced an approximately 40% reduction of its workforce due to which delay of the proposed CORAL Phase 2b study, which resulted in Gritstone not receiving external funding it previously anticipated beginning in 1Q 2024, associated with the initiation of the study.
    • 12 Feb 2024 According to a Gritstone bio media release, the company announced that it is now preparing to launch the Phase 2b head-to-head trial of its next-generation COVID-19 vaccine in the Fall of 2024 rather than 1Q24.

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