Volunteers from Stockport will soon be able to receive a third ‘booster’ COVID-19 vaccine through a new clinical trial launching this week, the Health Secretary has announced.
The Cov-Boost study, backed by £19.3 million of government funding through the Vaccines Taskforce, will be run at Stepping Hill 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.
At Stepping Hill Hospital, the Stockport NHS Foundation Trust Research and Innovation team are looking to recruit 148 volunteers in total, with 74 healthcare workers and 74 members of the public (with a focus on those aged 75 years and older) from the local Stockport area. The Cheadle Hulme Medical Group is assisting the Stockport NHS Foundation Trust Research and Innovation team in recruiting the volunteers. It is the only one of the test sites in Greater Manchester.
The team are looking for local people are aged 30 years or over, and who have received their first vaccine in December 2020 or January 2021, and have also received their second booster jab.
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, 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. 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.
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.
Wiesia Woodyatt, Research and Innovation Manager for Stockport NHS Foundation Trust said “We are delighted to be taken part in this groundbreaking research to support the national booster programme, which will form a huge part of the ongoing fight against COVID-19. If you fit the criteria then please get in touch with us atCOVBOOST@stockport.nhs.uk.”