Wearable tech, AI and clinical teams combine to change the face of clinical trial monitoring
23 January 2023
Publish date: 24 May 2021
UCLH is part of study announced by the Health Secretary in which volunteers will receive a third ‘booster’ Covid-19 vaccine.
The Cov-Boost study, backed by £19.3 million of government funding through the Vaccines Taskforce, is being led by University Hospital Southampton NHS Foundation Trust. It will be the first study in the world to provide vital data on the impact of a third dose on patients’ immune responses.
Professor Vincenzo Libri, who is leading the trial at UCLH, said: “The vaccination roll out programme has been hugely successful so far but it is vital that we carry out studies like this in order to inform what a future booster programme might look like.
“We encourage people from all sections of our local communities to apply to take part in this study, where participants will play a crucial role in helping to protect the health of the country and beyond going forwards.”
The study 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.
At UCLH the study will be conducted at the UCLH Vaccine Research Centre, part of the NIHR UCLH Clinical Research Facility, with the support of the NIHR UCLH Biomedical Research Centre.
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, 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.
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.
Rt Hon Matt Hancock MP, Health and Social Care Secretary, said: “We will do everything we can to future-proof this country from pandemics and other threats to our health security, and the data from this world-first clinical trial will help shape the plans for our booster programme later this year.
“I urge everyone who has had both doses of a COVID-19 vaccine and is eligible to sign up for this study and play a key part in protecting the most vulnerable for months to come.”
Image credit: Rido via Adobe Stock
23 January 2023
10 January 2023