World-first COVID-19 vaccine booster study launches in Oxford
Volunteers from Oxford will soon be able to receive a third ‘booster’ COVID-19 vaccine through a new clinical trial.
The Cov-Boost study, supported by the National Institute for Health Research (NIHR) and backed by £19.3 million of government funding through the Vaccines Taskforce, will be run at Oxford’s Churchill Hospital and is being led by University Hospital Southampton NHS Foundation Trust. It will be the first 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.
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.
The trial will look at seven different COVID-19 vaccines as potential boosters, given at least 10 to 12 weeks after a second dose as part of the ongoing vaccination programme. One booster will be provided to each volunteer and could be a different brand to the one they were originally vaccinated with. Vaccines being trialled include Oxford/AstraZeneca, Pfizer/BioNTech, Moderna, Novavax, Valneva, Janssen and Curevac, as well as a control group. The trial has received ethics approval by the NHS Research Ethics Committee, as well as approval from the Medicines and Healthcare products Regulatory Agency.
The study will be recruiting participants through the NHS COVID-19 Vaccine Research Registry - a website where people aged 18 and over can sign up to be contacted about taking part in vaccine trials - with vaccinations set to start from the beginning of June.
Participants will be adults aged 30 years or older and will include those immunised early on in the vaccination programme - for example, adults aged 75 and over or health and care workers.
The study will take place at 16 NIHR-supported sites across the UK and will include a total of 2,886 patients, including 185 in Oxford. 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.
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 by signing up to the vaccine registry.
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.
Dr Angela Minassian, the study’s lead investigator at the University of Oxford, said: “It is wonderful that so many people across the country have taken part in our COVID-19 vaccine trials up until now and we are hugely grateful for their continued support.
“We are now in an exciting position to be ready to study the effects of booster vaccinations and we hope that as many people as possible over the age of 30 who received their first dose early in the NHS rollout will come forward to take part by signing up to the NHS COVID-19 Vaccine Research Registry.
“The COV-BOOST study will be the first study worldwide to provide crucial data on the impact of a third dose of vaccine on the immune response in those previously vaccinated with two doses of either the AstraZeneca or Pfizer COVID vaccines.
“It will inform on whether such a booster vaccine is needed, and if so, which is the best vaccine to boost with, so that the JCVI can make key recommendations on how to protect the country’s most vulnerable against a future wave of infection.”
Professor Andrew Ustianowski, National Clinical Lead for the UK NIHR COVID Vaccine Research Programme said: “Throughout the pandemic, the National Institute for Health Research, the NHS and all of our research partners have helped to rollout vital studies to help us learn how to treat COVID-19 and develop effective vaccines. The Cov-Boost study marks the next step forward in our efforts of understanding how to best protect the population and inform future vaccine booster programmes.
“Since the launch of the NHS COVID-19 Vaccine Research Registry, thousands of volunteers have been recruited to key vaccine studies, and we are confident we can call upon our nearly half a million strong community to help recruitment to this important trial.”