University Hospitals Plymouth (UHP) has become the first research site in the world to successfully recruit more than 500 volunteers to ENSEMBLE 2, an international Covid-19 vaccine trial, and remains top of the leader board.
The study, which launched in November last year, seeks to recruit up to 30,000 people worldwide in order to test the safety and effectiveness of a new vaccine, which in conjunction with those already approved, aims to tackle the coronavirus pandemic.
“We were taken aback by the sheer numbers of volunteers who came forward to participate in the trial when it first launched,” explains Dr Claire Bethune, Consultant Immunologist and Principal Investigator for the study. “The Plymouth community and surrounding area have been exceptionally supportive of our work, so much so that we are the first site in the world to hit the recruitment target of 500. It’s amazing and we are incredibly grateful.”
As it stands, the research team at UHP have also consented, screened and randomised more participants than any other site.
Dr Gary Minto, Director of Research, Development and Innovation at UHP, adds: “Finding a successful vaccine is essential for us to be able to return to some level of normality. With that in mind, we have decided to extend our initial target and continue to recruit to this study from the large number of volunteers who have already registered their interest with us.
“We’d like to thank the people of Plymouth for their fantastic response and participation in this trial.”
What does the study involve?
- Participants receive two injections approximately two months apart; either the trial drug or a placebo (saline solution). Those who receive the drug are chosen at random using an anonymised computerised system.
- The trial utilises a symptom checker app which participants download on their phone or tablet at home, and asks for a quick survey of symptoms to be completed on a regular basis. If a COVID-19 symptom is flagged, the patient will have a swab test taken and receive clinical observations by the team.
- The research team will follow-up with participants via the app for 12 months after commencing the trial.
University Hospitals Plymouth NHS Trust (UHP) is an acute specialist hospital with a large and active Research and Development team, recognising that patients who take part in research have better outcomes. It recruits thousands of patients to participate in research each year, with approximately 600 trials running at any one time.