Researchers in Leicester are looking for people from a range of ethnic backgrounds to take part in a new study, investigating whether a new booster vaccine can provide better protection against the COVID-19 Omicron variant.
The study will be run by Patient Recruitment Centre (PRC): Leicester, which is funded by the National Institute for Health Research (NIHR) and located at Leicester General Hospital.
The Omicron variant was designated a ‘variant of concern’ by the World Health Organisation (WHO) in November 2021. Study sponsor, Moderna, are hoping an updated vaccine against Omicron is a more effective booster than their authorised vaccine Spikevax, which is based on the original COVID-19 virus detected in late 2019.
Spikevax has shown high levels of efficacy against variants such as Alpha and Delta, and has some protection against Omicron as well. However the mutations in the Omicron variant are distinct enough that researchers suspect an updated version of the vaccine may produce a more robust response from the immune system, which defends the body against infection.
Professor Adrian Palfreeman, a consultant in infectious diseases at the University Hospitals of Leicester NHS Trust and principal investigator for the study, met with the Leicester Times to explain the importance of Leicester at a place of research, owing to its diverse ethnic population.
“We’ve got a significant ethnic diversity in Leicester – there’s no ethnic majority in Leicester – so it’s important to make sure that the findings of this study are going to be applicable to everybody,” he said.
“At PRC: Leicester, we are keen to ensure that we include as broad a range of people as possible, which is why we are looking for volunteers of all genders from all ethnic backgrounds and of different ages from 16 to the elderly to join the study so we can see if this new booster vaccine provides protection for everyone,” he said.
“We’re hoping to recruit as many people from Leicester as possible.”
The global study is classed as a phase 3 trial, which means it is comparing a new treatment with the standard treatment currently available. It is expected that up to 4,000 participants will be recruited in the UK.
To take part in the study, participants need to be 16 years of age and older, be in good health, have received either two or three doses of an authorised COVID-19 vaccine, having had their last dose at least three months ago, and have not tested positive for COVID-19 in the last 90 days. Participants will be randomly assigned to receive a single dose of either the new booster vaccine or the currently authorised vaccine, Spikevax.
The study will follow the participants for up to 13 months and involves visits to the NIHR Patient Recruitment Centre at Leicester General Hospital and phone calls from the clinical team.
Professor Adrian Palfreeman, said that it was important to find vaccines to protect against serious illness as new strains of COVID-19 regularly emerge.
“The existing vaccines that we’ve got in the UK were all originally derived from the Wuhan strain, which was the strain that appeared a couple of years ago now, despite the fact that the virus has evolved over time,” he said.
“The existing vaccines still seem to be very effective in terms of preventing serious disease, hospitalisation and death, so it’s important to establish whether this modified vaccine is at least as good as those, and hopefully better, and that’s also very important because the virus is likely to evolve in the future, and its future evolution is likely to be an evolution of what we’ve got at the moment,” he added.
“We have an outstanding track record in delivering COVID-19 vaccine research, which is why we have been selected to run this trial. We are thrilled to bring this opportunity to the people of Leicester and the East Midlands.
The PRC is one of five in England, dedicated to setting up and delivering late phase commercial clinical trials in the NHS at pace and scale. PRC: Leicester is hosted by the University Hospitals of Leicester NHS Trust.
To find out more about this study and to see if you are eligible to take part, contact the research team by emailing: PRCLeicester@uhl-tr.nhs.uk or call 0116 258 8689.
