Published: 23 November 2020
A UK study participant in Yorkshire is the first in the world to receive a new COVID-19 monoclonal antibody treatment, developed by AstraZeneca.
The large-scale phase 3 study, which opened for recruitment this week, will recruit 5,000 people worldwide. While in the UK, with NIHR support, 1,000 participants will be recruited to the study across nine UK sites, in Manchester, London, Plymouth, Southampton, West Yorkshire, Enfield, Rochdale and Preston.
The AstraZeneca study called PROVENT is focusing on the safety and effectiveness of a long-acting antibody (LAAB) combination called AZD7442, and will test whether the treatment will prevent Covid-19 for up to a year. Following potential exposure to the virus, the study will enrol adults who are at increased risk of inadequate response to vaccination or increased risk of COVID-19 infection.
The NHS vaccines registry will invite 5,000 participants to take part in the study - with researchers calling on more volunteers to register their interest to take part.
The NHS Vaccine Registry was launched by the government in partnership with the NIHR, NHS Digital, the Scottish and Welsh governments and the Northern Ireland Executive in July. It aims to help create a database of people who consent to be contacted by the NHS to take part in clinical studies, to help speed up the development of a safe and effective vaccine. The registry has been developed as part of the UK Government’s Vaccine Taskforce.
Prof Andrew Ustianowski, Joint National Specialty Lead for Infection, National Institute of Health Research (NIHR), and Chief Investigator of the study said:
"This is a really exciting development in the fight against COVID-19, which takes a very different approach to other studies involving vaccines. Vaccines work mainly by inducing a person's immune system to produce antibodies that inhibit or 'neutralise' the virus, but some people don't respond well to vaccines, or cannot be given them.
"What we are investigating in this study is whether we can provide protection by giving antibodies that have been shown to neutralise the virus, by injection into the muscle. The hope is that this will then provide good protection for many months against infection."
Sir Mene Pangalos, Executive Vice President BioPharmaceuticals R&D, AstraZeneca said:
“Today is an exciting milestone in the development of our long-acting antibody combination, which has the potential to provide an immediate and long-lasting effect in both preventing and treating COVID-19 infection. We are thrilled that the UK is the first country to begin this important Phase III trial. Through our development programme, we will be evaluating AZD7442 in different settings including prophylaxis and outpatient treatment, with a focus on helping the most vulnerable people.”
Business Secretary Alok Sharma said:
“I am very proud that the UK is the first country in the world to begin this invaluable study, and that a fifth of trial volunteers will be from Britain – a testament to our fantastic life sciences sector and the willingness of our people to come forward to help others.
“As we move closer to a COVID-19 vaccine, we must keep driving forward clinical trials for new and alternative treatments that protect our vulnerable, particularly those who cannot receive a vaccine. That is why we have procured one million doses of AstraZeneca’s long-acting antibody treatment if it meets robust safety and effectiveness standards.”
Head of the Government's Vaccine Taskforce, Kate Bingham, said:
"It's crucial that we leave no one behind as we move closer to finding both a vaccine and developing more treatments for COVID-19. We particularly need to ensure those cannot be given a vaccine, such as people who are immunocompromised, have alternatives available that will help protect them.
“That's why we are working at pace to recruit people into this study to find the long-term solutions we need for a range of people as quickly as possible."