Local volunteers are being sought to take part in a new trial that will investigate the use of different COVID-19 vaccines as a third ‘booster’ injection.
The Cov-Boost study, backed by £19.3 million of government funding through the Vaccines Taskforce, is being run in 18 sites across the UK, including the National Institute for Health Research (NIHR) Leicester Clinical Research Facility based at Leicester’s Hospitals. It is the first study in the world to provide vital data on the impact of a third dose on patients’ immune responses.
It will give scientists from around the world and the experts behind the UK’s COVID-19 vaccination programme a better idea of how effective a booster of each vaccine is in protecting the individual from the virus.
Dr Adrian Palfreeman, consultant in infectious diseases at Leicester’s Hospitals and principal investigator for the study, said: “We’re really pleased that the Cov-Boost study is now open to recruitment. We are particularly keen to hear from people over the age of 70 who have received two doses of the COVID-19 vaccine. To be eligible for the study, participants will need to have had both doses before 23 March 2021 for the Pfizer vaccine, or before 6 April 2021 for the AstraZeneca vaccine.”
He added: “With the increase in known variants of coronavirus, it is really important that COVID-19 booster vaccines are made available for those in the higher risk groups in our community. Through the Cov-Boost study we aim to find out which vaccines against COVID-19 are effective and safe as a booster vaccination, and at what dosage, to help support future decision-making.”
The initial findings, expected in September, will help inform decisions by the Joint Committee on Vaccination and Immunisation (JCVI) on any potential booster programme from autumn this year, ensuring the country’s most vulnerable are given the strongest possible protection over the winter period.
Robert, 81, is taking part in the Cov-Boost study. He said: “I’m taking part because it’s important to know whether it is necessary for people to have a booster vaccine. The trial process is well-organised, the staff are friendly and personable, and it’s not difficult to do or time-consuming. I’ve always had a good experience with the NHS, so it’s nice to be able to do something above and beyond.”
All participants will be monitored throughout the study for any potential side effects and will have bloods taken to measure their immune responses at days 28, 84, 308 and 365, with a small number having additional blood tests at other times. All sites will have an electronic diary for all participants that will send alerts to the team in real time if needed and a 24-hour emergency phone to a doctor on the study, who can provide further clinical advice. Participants will be compensated for their time, inconvenience and travel.
All the trial sites are working on ways of including people in research from a wide variety of backgrounds and individuals from ethnic minorities are encouraged to apply.
The government is preparing for a potential booster programme based on clinical need and will publish further details in due course. The final policy will be informed by advice from the JCVI and take into account the results of clinical trials.