MFT recruits final participant to Phase 3 COVID-19 vaccine study

Manchester University NHS Foundation Trust (MFT), England’s largest NHS trust, has recruited its final participant to a leading COVID-19 vaccine trial.

The Phase 3 study is testing the safety and effectiveness of a new two-dose vaccine regimen, versus a placebo, in preventing moderate to severe/critical coronavirus disease.

The vaccine candidate has been developed by The Janssen Pharmaceutical Companies of Johnson & Johnson, as researchers around the world continue to work to secure a range of vaccines and treatments to help tackle coronavirus.

Dr Tim Felton, an Honorary Consultant at MFT’s Wythenshawe Hospital, is the Trust’s Clinical Lead for all COVID-19 research, as well as the Principal Investigator at MFT for the Janssen Phase 3 study.

Dr Felton, who is also a Senior Lecturer at The University of Manchester and a researcher within NIHR Manchester Biomedical Research Centre (BRC) Respiratory Theme, said: “Throughout all the research we have undertaken into COVID-19 at MFT, finding a safe and effective vaccine has been the top priority.

“Recruiting our final participant into this study is a major step forward in our fight against coronavirus – and I’d like to thank every person who has volunteered to take part in this vital research.

“It is critical that we explore a range of vaccination options to give us the greatest chance of protecting as many people as possible, as we continue to the global effort to tackle the COVID-19 pandemic.”

Dr Claire Cole, the Head of Research Delivery at MFT, was the first person in the world to be consented into the Janssen trial when it opened on 16 November 2020.

MFT has now recruited 405 participants to the study, exceeding its target of 400 within just eight weeks. Globally, recruitment into the study is due to complete in March 2021, with 6,000 volunteers taking part in the UK and 30,000 worldwide.

Dr Cole said: “Although I have worked in health research for a number of years, I never cease to be amazed by the life-changing – and sometimes lifesaving – impact research can have.

“I wholeheartedly believe in the importance of taking part in research and was honoured to be the first person in the world to be recruited to the study, as part of this vitally important COVID-19 vaccine trial.

“But I am especially proud of the resilience of the multidisciplinary study team here at MFT, who have managed to recruit the required number of participants and start administering second doses within just two months – an incredible achievement considering the current global landscape.”

Across the UK, volunteers from a variety of age groups and backgrounds – including some of the thousands who registered to be contacted about vaccine studies through the NHS COVID-19 Vaccine Research Registry – have been taking part in the study.

Stephanie Gill, a headteacher, was contacted to take part in the study at MFT after signing up to the vaccine registry.

The 51-year-old from Sale, Manchester, said: “When I received my invite to take part, I was really excited.

“I’ve never taken part in research before, but all the research staff here have been absolutely brilliant.”

Having now received two doses as part of the blind study, Stephanie does not know whether she received the vaccine candidate or the placebo.

“While I of course hope I received the vaccine, the blind element is the whole point of the trial. I just wanted to contribute, so even if I’ve had the placebo, I’ve contributed to this important research.”

All study participants will be monitored for 112 weeks after vaccination.

At MFT the trial is being delivered in collaboration with the NIHR Clinical Research Network Greater Manchester (CRN GM).

More about the Janssen (Ad26.COV2.S) vaccine

Like other vaccines, Ad26.COV2.S is expected to prepare the body to defend itself against infection. It contains genetic instructions for what is known as ‘the spike protein’, which is present on the surface of the coronavirus.

When a person is given the vaccine, their cells will read the genetic instructions and produce the spike protein. The person’s immune system will then treat this protein as foreign and produce natural defences – antibodies and T-cells – against it.

If the vaccinated person later comes into contact with COVID-19, their immune system will recognise the virus, with antibodies and immune cells working together to kill it and prevent its entry into the body’s cells.

• The UK public can support the national effort to speed up vaccine research and receive more information about volunteering for clinical studies by visiting: nhs.uk/conditions/coronavirus-covid-19/research/coronavirus-vaccine-research/

• The ENSEMBLE 2 Janssen study is trialling a two-dose Janssen COVID-19 vaccine regimen. The results of a separate study, ENSEMLBE, which trialled a single-dose Janssen COVID-19 vaccine candidate, were recently published.

Picture: Dr Claire Cole – Head of Research Delivery at MFT –who was the first global recruit to the trial. The photo has taken in November when she had her first dose.