Coronavirus (COVID-19) vaccine trial led by St George’s researchers open for recruitment
Published: 24 April 2020
The Vaccine Institute at St George’s, University of London is leading the trial of a vaccine against the new coronavirus (COVID-19) with the support of St George’s University Hospitals NHS Trust. The trial is now open for recruitment and will be the first time a vaccine against this coronavirus has been tested in people in the UK.
Designed and organised by the University of Oxford, St George’s will be one of five sites around the country hosting the trial. The Phase I/II trial will at first be testing the safety of the vaccine, before going on to test whether it is effective in preventing coronavirus in the Phase II/III trial.
In the Phase I/II trial the study team are aiming to recruit around 150 participants in the next two weeks to receive the vaccine at St George’s. The volunteers will be adults aged 18-55 years old in generally good health, who have not had the COVID-19 infection, and who are not currently pregnant or breastfeeding.
Professor Paul Heath, who is leading the study at St George’s, University of London, said: “In the first instance, we want to demonstrate whether this vaccine is safe and is effective at preventing coronavirus. If the vaccine passes those initial tests, it could then proceed to the next phase, where large numbers of doses are made, and the vaccine can be rolled out on a wider scale.
“The whole development process is being accelerated at the moment, and we hope that if this vaccine is found to work, it could be implemented within the UK and beyond as quickly as possible.”
The study will involve coming to a screening visit to check eligibility to receive the vaccine and then another visit a few days later to receive the vaccine. Participants will then be followed up over several months and asked to fill out an online diary of side-effects for one week after the vaccine is given.
Half the participants in the study will receive the new coronavirus vaccine, while the other half will receive another vaccine, not designed to protect against coronavirus. In this case, the other vaccine, known as a control, will be an already existing vaccine, designed to prevent meningococcal disease.
Following this, in the much larger Phase II/III trial, in order to understand whether the new vaccine works, the researchers will be comparing the number of new cases of coronavirus in those who have received the new vaccine, with those who receive the control vaccine. They hope to see a significant reduction of coronavirus cases in those receiving the new vaccine.
The vaccine itself will consist of a type of virus called an adenovirus, which has been deactivated and combined with a protein from the virus that causes COVID-19. The adenovirus used in this vaccine typically affects chimpanzees, but is known to be harmless in healthy human populations. It has previously been tested as the vehicle for a vaccine against the Middle-East Respiratory Syndrome (MERS) coronavirus, which is closely related to COVID-19. The addition of the “spike protein” from the COVID-19 virus, is what the scientists hope will cause an immune response in participants, leading to the production of antibodies that can prevent future infections.
More information on the trial can be found at: https://covid19vaccinetrial.co.uk/volunteer