World’s first COVID-19 vaccine booster clinical trial begins

World’s first COVID-19 vaccine booster clinical trial begins
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The world’s first clinical trial looking at seven different COVID-19 booster vaccines has begun in the UK, with initial results expected in September.

As part of the Cov-Boost trial, led by University Hospital Southampton NHS Foundation Trust and backed by £19.3m of government funding through the Vaccines Taskforce, thousands of participants will receive COVID-19 booster vaccines, providing vital data on the impact of a third dose on patients’ immune responses.

The vaccines being trialled include Oxford/AstraZeneca, Pfizer/BioNTech, Moderna, Novavax, Valneva, Janssen and Curevac, and a control group.

Understanding immune responses

The study will be conducted across 16 NIHR-supported sites across England, and Care Research Wales, and NHS Research Scotland sites, and will include a total of 2,886 patients and participants who will be vaccinated from early June.

The study will monitor for any side effects and participants 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. The boosters will be given at least 10 to 12 weeks after a second dose as part of the ongoing vaccination programme, and one booster will be provided to each volunteer which could be a different brand to the one they were originally vaccinated with.

The initial findings will help inform decisions by the Joint Committee on Vaccination and Immunisation (JCVI) on plans for a booster programme from autumn this year.

Health and Social Care Secretary, Matt Hancock said: “The UK vaccination programme has been a phenomenal national effort, with seven in 10 UK adults now having had their first COVID-19 jab. It is vital that we continue to support the world-renowned British research sector that has contributed to its success.

“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 part in protecting the most vulnerable people in this country and around the world for months and years to come.”

The study will open for applications from volunteers shortly via the study’s website and will be recruiting participants through the NHS COVID-19 Vaccine Research Registry. Participants will be adults aged 30 years or older as these will have been those immunised early in the vaccination programme.

Chief Investigator and Director of NIHR Southampton Clinical Research Facility Professor Saul Faust said: “This trial will give the Joint Committee on Vaccination and Immunisation the important data to inform their recommendations of how to protect the population against any future wave. It is fantastic that so many people across the country have taken part in vaccine trials up to now so that we can be in a position to study the effects of boosters, and we hope that as many people as possible over the age of 30 who received their first dose early in the NHS programme will be able to take part.”

The UK’s vaccination programme continues at record pace, with over 57.8 million vaccines administered in total – 36.9 million first doses, which amounts to seven in 10 UK adults being given one jab – and 20.8 million second doses, which gives people even stronger protection.

Initial results from this trial have shown that mixing the doses slightly increases the frequency of mild-to-moderate symptoms following vaccination, but there were no serious outcomes. The government is preparing for a booster programme based on clinical need and will publish further details in due course.

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