Rapid development of manufacturing processes for future production of adenovirus-vectored COVID19 vaccine at million-dose scale

  • Funded by Department of Health and Social Care / National Institute for Health and Care Research (DHSC-NIHR), UK Research and Innovation (UKRI)
  • Total publications:8 publications

Grant number: MC_PC_19058

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Key facts

  • Disease

    COVID-19
  • Start & end year

    2020
    2020
  • Known Financial Commitments (USD)

    $527,399.42
  • Funder

    Department of Health and Social Care / National Institute for Health and Care Research (DHSC-NIHR), UK Research and Innovation (UKRI)
  • Principle Investigator

    Pending
  • Research Location

    United Kingdom, Europe
  • Lead Research Institution

    University of Oxford
  • Research Category

    Vaccines research, development and implementation

  • Research Subcategory

    Clinical trial (unspecified trial phase)

  • Special Interest Tags

    Gender

  • Study Subject

    Clinical

  • Clinical Trial Details

    Unspecified

  • Broad Policy Alignment

    Pending

  • Age Group

    Unspecified

  • Vulnerable Population

    Unspecified

  • Occupations of Interest

    Unspecified

Abstract

This COVID-19 Rapid Response award is jointly funded (50:50) between the Medical Research Council and the National Institute for Health Research. The figure displayed is the total award amount of the two funders combined, with each partner contributing equally towards the project. We aim to provide, in <6 months and probably c. 4 months -A GMP process to produce the University of Oxford's (UOXF's) simian adenovirus-vectored COVID-19 vaccine at 200L/ c. 1m-dose scale -With MHRA engagement, a contingency plan (subject to funding) to make available 1m doses of GMP-like UK-cleanroom-produced material for clinical use as soon as possible. -Development of options for 1000L-scale (>5m dose) manufacturing in UK & abroad. Small-batch GMP and clinical trials of the UOXF vaccine are already planned. Supported by the extensive human safety/ immunogenicity record of these vectors, and anticipating supportive primate efficacy/ immunopathology safety data in April, we are contingency planning an emergency clinical trial programme. With a £0.25m in-kind contribution from PallBiotech, including access to a fully-equipped process development (PD) facility, and starting from our existing GMP 3L-scale process, we are already performing scale-up preparation experiments and anticipate a 50L run at Pall's facility and then 200L runs as needed, within funds requested here. With Co-I J Humphreys (VMIC), we are contingency planning near-immediate access to 200L-capable cleanrooms at two CDMOs, both partners in this application (Cobra in Keele, UK & Halix in Leiden NL). We have requested an emergency meeting with MHRA to discuss regulatory mechanisms to make vaccine available for large-scael use as soon as possible.

Publicationslinked via Europe PMC

Last Updated:41 minutes ago

View all publications at Europe PMC

Lyophilization to enable distribution of ChAdOx1 and ChAdOx2 adenovirus-vectored vaccines without refrigeration.

Manufacturing a chimpanzee adenovirus-vectored SARS-CoV-2 vaccine to meet global needs.

Single-dose administration and the influence of the timing of the booster dose on immunogenicity and efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine: a pooled analysis of four randomised trials.

Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomised, controlled, phase 2/3 trial.

Phase 1/2 trial of SARS-CoV-2 vaccine ChAdOx1 nCoV-19 with a booster dose induces multifunctional antibody responses.

T cell and antibody responses induced by a single dose of ChAdOx1 nCoV-19 (AZD1222) vaccine in a phase 1/2 clinical trial.

Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK.

Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial.