Authors: Heather Jones, Future Science Group
Amid the widespread surge of efforts to develop a vaccine for COVID-19, one researcher, Sarah Gilbert, a professor of vaccinology at the University of Oxford (UK) believes she may have the answer. A recent paper, published in The Lancet, outlines her journey so far, as her team pushes to develop their vaccine by Autumn 2020.
When news of a novel coronavirus outbreak was reported in January 2020, an Oxford-based research team, led by Sarah Gilbert, was keen to rise to the occasion. “We had recently started thinking about an appropriate response to Disease X; how could we mobilize and focus our resources to go more quickly than we had ever gone before. And then Disease X arrived,” stated Gilbert within the article published by The Lancet.
The genome of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was sequenced and made available in mid-January. Using recombinant DNA techniques, Gilbert’s team began designing their vaccine comprising a SARS-CoV-2 antigen embedded within a primate adenovirus vector.
In order to advance their efforts to push their vaccine candidate through preclinical and clinical trials, Gilbert’s team was awarded a £2.2 million grant. This grant provided a huge boost to their research. Further, Gilbert explained that much of the work can go on in parallel. For example, her colleague Sandy Douglas (Jenner Institute, Oxford, UK) has received funding to scale up the vaccine manufacturing processes at the same time as work is progressing in developing trials.
Gilbert’s team has already received ethical approval for a clinical trial, and conditional approval to screen volunteers for trial enrolment.
Along with the global urgency for a vaccine to protect populations, Gilbert is also conscious that in order to test the efficacy of the vaccine, most volunteers for the trial need to be previously unexposed to the virus. This therefore increases the need for speed of clinical trial commencement, and Gilbert will exclude volunteers who test positive for SARS-CoV-2, or who have had a fever or cough in the past month.
Gilbert hopes to have vaccinated 500 volunteers by mid-May, followed by an extension of the maximum age of trial volunteers from 55 to 70 years.
Expansion of Phase III trials is predicted to involve 5000 volunteers, with results from earlier trials to be included in the follow-up. Gilbert commented in the article that she anticipates a “best-case scenario” of a Phase III efficacy result and the ability to manufacture large amounts of the vaccine by Autumn 2020, while also recognizing that these timeframes are highly ambitious.
Source: Lane R. Sarah Gilbert: carving a path towards a COVID-19 vaccine. The Lancet. doi: 10.1016/S0140-6736(20)30796-0 (2020) (Epub ahead of print)