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Oxford’s COVID-19 Vaccine Program Opens for Clinical Trial Recruitment; Vaccine Is Adenoviral Vector Containing Genetic Code for COVID-19 Spike Protein; Large-Scale Manufacturing Work Begins Immediately to Asssure Adequate Supply If Trial Goes Well

University of Oxford researchers, working in an unprecedented vaccine development effort to prevent COVID-19, started screening healthy volunteers (aged 18-55) on March 27, 2020 for their upcoming ChAdOx1 nCoV-19 vaccine trial in the Thames Valley Region. The vaccine, based on an adenovirus vaccine vector and the SARS-CoV-2 spike protein, is already in production. but won’t be ready for some weeks still. The team will enroll healthy volunteers aged between 18 – 55, who, if they pass screening, will be the first humans to test the new vaccine, called ChAdOx1 nCoV-19. The trial will provide valuable information on the safety aspects of the vaccine, as well as its ability to generate an immune response against the virus. [UPDATE: The trial has received a high volume of volunteer applications and is not accepting any more at this moment. Please do keep checking the trial website, https://covid19vaccinetrial.co.uk, for future COVID-19 vaccine studies.] The trial, a collaboration between the University’s Jenner Institute and Oxford Vaccine Group clinical teams, will recruit up to 510 volunteers, who will receive either the ChAdOx1 nCoV-19 vaccine or a control injection for comparison. While the team will start screening people now to see if they are eligible to take part in the study, participants will not receive the vaccine for some weeks. Detailed preclinical work is being done and the vaccine is being manufactured to clinical-grade standard at the Clinical Biomanufacturing Facility at Oxford University. The trial has been approved by UK regulators and ethical reviewers. Researchers are working as quickly as possible to get the vaccine ready to be used in the trial, which includes further preclinical investigations and production of a larger number of doses of the vaccine. Professor Adrian Hill, Director of the Jenner Institute at the University of Oxford, said, “The Oxford team had exceptional experience of a rapid vaccine response, such as to the Ebola outbreak in West Africa in 2014. This is an even greater challenge. Vaccines are being designed from scratch and progressed at an unprecedented rate. The upcoming trial will be critical for assessing the feasibility of vaccination against COVID-19 and could lead to early deployment.”

Professor Andrew Pollard, Chief Investigator on the study, said, “Starting the clinical trials is the first step in the efforts to find out whether the new vaccine being developed at Oxford University works and could safely play a central role in controlling the pandemic coronavirus that is sweeping the globe.”

Scientists around the world are working hard to develop a vaccine to prevent COVID-19, but there is a lot to be done. The Oxford team led by Professor Sarah Gilbert, Professor Pollard, Professor Teresa Lambe, Dr. Sandy Douglas, and Professor Hill started work designing a vaccine on Friday, January 10, 2020.

VACCINE

The vaccine is an adenovirus vaccine vector (ChAdOx1) that was developed at Oxford’s Jenner Institute. It was chosen as the most suitable vaccine technology for a SARS-CoV-2 (COVID-19) vaccine as it can generate a strong immune response from one dose and it is not a replicating virus, so it cannot cause an ongoing infection in the vaccinated individual. This also makes it safer to give to children, the elderly and anyone with a pre-existing condition such as diabetes. Adenoviral vectors are a very-well-studied vaccine type, having been used safely in thousands of subjects, from 1 week to 90 years of age, in vaccines targeting over 10 different diseases.

Coronaviruses have club-shaped spikes on their outer coats. Immune responses from other coronavirus studies suggest that these are a good target for a vaccine. The Oxford vaccine contains the genetic sequence of this surface spike protein inside the ChAdOx1 construct. After vaccination, the surface spike protein of the coronavirus is produced, which primes the immune system to attack the coronavirus if it later infects the body. Professor Gilbert and team have previously developed a vaccine for another human coronavirus disease, which is Middle East Respiratory Syndrome (MERS), and this has shown promise in early clinical trials.

Professor Gilbert, lead researcher of the vaccine development program, said, “Since the Ebola outbreak in West Africa in 2014, my research team has been working on new approaches to vaccine development to protect the population of the world against an outbreak of infectious disease or a pandemic. We are now working with a much larger team to bring these plans to fruition.”

VACCINE PRODUCTION

At the same time as conducting the first clinical trial, production of the vaccine is being scaled up ready for larger trials, and potentially, future deployment. By starting vaccine manufacturing scale-up immediately, the team can ensure that enough vaccine doses are available as soon as possible--especially for National Health System (NHS) workers, the elderly, and those with underlying health conditions--if the trials prove that the vaccine is safe and effective.

Dr. Douglas, who is leading the vaccine manufacturing scale-up project, said, “The scale of this epidemic poses a huge challenge for vaccine manufacturing. We need to follow rigorous safety standards and that takes time. By starting work on large-scale manufacturing immediately, we hope to accelerate the availability of high quality, safe vaccine.”

Professor Lambe, who is leading the early stages of vaccine development said, “The commitment, compassion, and helpfulness felt throughout the whole effort from everyone we have been working with has been amazing. We deeply appreciate the support of all our collaborators, funders and the teams around us in getting to this stage with the speed we have.”

PRECLINICAL WORK

Preclinical work on the ChAdOx1 nCoV-19 vaccine is being conducted in collaboration with: Rocky Mountain Laboratories (NIH/NIAID); The “CSIROxbridge Consortium;” Public Health England; The Pirbright Institute; and Professor Dr. Stephen Becker at the Institut für Virologie, Philipps‐Universität Marburg.

MANUFACTURING

Manufacturing is being conducted in collaboration with Professor Cath Green and the University of Oxford Clinical Biomanufacturing Facility, the Vaccine Manufacturing and Innovation Centre (Oxford), Advent Srl (Italy), Pall Biotech (Portsmouth), Cobra Biologics (Staffordshire), and Halix BV (Netherlands).
This study is a collaborative project which would not have been possible without the support of the collaborating partners.

FUNDING

The work receives funding from the rapid research response funded by UK Research and Innovation (UKRI), and by the Department of Health and Social Care through the National Institute for Health Research (NIHR). The NIHR has also provided funding for the set-up of the project through the Oxford Biomedical Research Centre (BRC). The study has received funding from the Coalition for Epidemic Preparedness Innovations (CEPI) as part of an urgent call to expand the number of COVID-19 vaccine candidates in development. Funding has also been received from the Chinese Academy of Medical Sciences (CAMS) Innovation Fund for Medical Science (CIFMS). The “CSIROxbridge Consortium” (Principal Investigator Professor S. S. Vasan) is led by Australia’s science agency CSIRO for “High Containment Studies to Support Product Development’ for CEPI.”

[Press release] [Oxford COVID-19 Vaccine Website]