Mild Covid-19 infection very unlikely to cause lasting heart damage
10 May 2021
Publish date: 26 April 2021
Volunteers are being asked to sign up to the latest Covid-19 vaccine study to begin across the UK including at UCLH.
The National Institute for Health Research (NIHR)-supported Valneva Phase 2/3 study, called COV-COMPARE, is open to healthy adults who have not had a previous Covid-19 vaccine. Valneva is a global biotech company.
At UCLH the study will be led by Principal Investigator Dr Tommy Rampling and study co-Investigator Professor Vincenzo Libri. The study will be conducted at the UCLH Vaccine Research Centre, part of the NIHR UCLH Clinical Research Facility, and it is supported by the NIHR UCLH Biomedical Research Centre.
4,000 participants will be recruited across the UK, and everyone involved in the study will receive two active vaccine doses, administered in a four week interval. Those enrolled in the study over the age of 30 will be randomised to receive two doses of either the Valneva vaccine, or the approved Oxford/AstraZeneca vaccine. Participants aged 18 - 29 can be enrolled into the study to receive the Valneva vaccine and will not be offered the approved Oxford/AstraZeneca vaccine.
Developed by Valneva, the vaccine is being manufactured at the company’s site in Livingston, West Lothian, and is the only inactivated, adjuvanted (an ingredient to create a stronger immune response) Covid-19 vaccine in clinical development in Europe.
Volunteers for the study will be vaccinated at the beginning of May, and a proportion of potential participants will be identified through the NHS COVID-19 Vaccine Research Registry, which currently has over 480,000 sign ups. Subject to successful Phase 2/3 data, Valneva aims to make regulatory submissions for initial approval in the autumn of 2021.
If Valneva’s vaccine is shown to be safe and effective, up to 250 million vaccine doses could be supplied to the UK and other countries around the world. As part of the UK government’s vaccine procurement approach, up to 100 million doses of this vaccine have been secured.
Dr Tommy Rampling, Principal Investigator of the trial at UCLH, which will take place at the NIHR UCLH Clinical Research Facility, with the support of the NIHR Biomedical Research Centre at UCLH, said: “We need as many approved vaccines in use as possible, so in addition to the vaccines that have already been approved, we hope to be able to show that the Valneva vaccine is safe and effective.
“We encourage all sections of our local communities to sign up the take part in this study, which we will be conducted at our dedicated Vaccine Research Centre. Our research successes so far have been thanks to the participants who have volunteered their time and efforts to help us emerge from this pandemic.”
Professor Vincenzo Libri, Director of the NIHR UCLH Clinical Research Facility which oversees the Covid-19 vaccine trial program at UCLH, and co-Investigator of the Valneva trial said: “We are proud to add this Covid-19 vaccine trial to our portfolio and to continue as a leading UK hospital in the prevention of this horrendous disease. We encourage as many volunteers as possible to take part in the trial, hopefully for their own protection and to contribute to development of a new safe and effective vaccine.”
As the roll out of Covid-19 vaccines has started in the UK and as people are invited to receive an approved vaccine, a process is in place to make sure participants on this trial are not disadvantaged. More information can be found on the NIHR website.
More information about the study can be found on the study website.
To register interest in vaccine studies and sign up to be contacted by researchers, people can visit the NHS COVID-19 Vaccine Research Registry.
Image: Thaut Images / Adobe Stock