University of Oxford investigators have initiated enrollment of healthy participants in a trial testing the COVID-19 vaccine candidate called ChAdOx1 nCoV-19. Originally developed to target MERS, it is based on an adenovirus vaccine vector and the COVID-19 spike protein. It is currently being manufactured in the University of Oxford’s Clinical Biomanufacturing Facility and will be ready within weeks.

Background

The University of Oxford’s The Jenner Institute has agreed to produce the vaccine with an Italian manufacturer called Advent Srl to initially produce the first batch of the novel coronavirus vaccine for clinical testing back in February. According to a University of Oxford news release then, the vaccine ‘seed stock’ is produced at the University’s Clinical Biomanufacturing Facility and would be transferred to Advent who planned on producing 1,00 doses for the fist clinical trials of the vaccine known as ChAdOx1 nCoV-19.

As it turns out, The Jenner Institute was using this experimental vaccine candidate to target another coronavirus, Middle East Respiratory Syndrome (MERS), which has been shown to induce strong immune responses against MERS after a single dose of the vaccine in the first clinical trial which happened at Oxford. A second clinical trial has bene underway, targeting MERS, in Saudi Arabia.

The Study

The study, a Phase I/II single-blinded, randomized, placebo controlled, multi-center study that the sponsors hope will help them determine the efficacy, safety and immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19 in UK healthy adult volunteers aged 18-55. The vaccine will be administered via intramuscularly (IM). The study involves three arms with five interventions.

The clinical trial will include up to 510 participants ages 18 to 55 and will be led by the university’s Jenner Institute and Oxford Vaccine Group. The investigators, by comparing ChAdOx1 nCoV-19 to a control injection, will assess the experimental vaccine’s safety and ability to trigger an immune response against COVID-19. The study commenced in March 2020 and runs through May 2021.

Reports indicate the university researchers are pursuing additional preclinical tests to assess safety while they commit to invest in the manufacturer of large numbers of units prior to the clinical trial. The Oxford investigative team has had significant experience developing dealing with public health emergencies involving virus’ such as the Ebola outbreak in 2014.

What is ChAdOx1 nCoV-19?

Developed at University of Oxford, it is a safe version of an adenovirus. It has been modified so that it cannot reproduce within the body, and the genetic code to provide instructions for making the coronavirus Spike protein have bene added, enabling the adenovirus to produce this protein after vaccination. This results in the formation of antibodies to the Spike protein, which is known to be on the surface of SARS-CoV-2.

Research Sites

In addition to University of Oxford itself, the sponsor has organized the following participating sites including NIHR WTCRF, University Hospital Southampton NHS Foundation Trust, Imperial College Healthcare NHS Trust and John Radcliffe Hospital in Oxford.

Oxford’s Jenner Institute

The University of Oxford’s Jenner Institute is a key player in the development of this vaccine. They are based within the Nuffield Department of Medicine at the University of Oxford and operate out of the Old Road Campus Research Building in Headington. The Jenner Institute supports senior vaccine scientists (Jenner Investigators) within many other departments within the University of Oxford as well as externally within the Pirbright Institute and the Animal and Plant Health Agency. The Jenner Institute brings together investigators who are designing and developing numerous vaccines to generate an exceptional breadth of scientific know-how and critical mass, while still allowing the individual investigators to remain independent and accountable to their funders and stakeholders. Key people (including investigators) are included in their “organigram.” 

Professor Sarah Gilbert with the Institute has been active with this vaccine and reports, “Novel pathogens such as nCOV-19 require rapid vaccine development. By using technology that is known to work well for another coronavirus vaccine we are able to reduce the time taken to prepare for clinical trials. Advent are working with us to move as rapidly as possible.”

For more on the University of Oxford vaccine activity, see their website here.

Lead Research/Investigator

Andrew Pollard, BSc MBBS PhD (Lond), DIC, MRCP (UK), FHEA, FIDSA, FRCPCH, MA, FMedSci

Source: University of Oxford

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