World’s first COVID-19 vaccine booster study launches in UK
pharmafile | May 20, 2021 | News story | | COVID-19, UK government, booster vaccine, clinical trial, vaccines
The UK government has announced that thousands of volunteers will receive a booster COVID-19 vaccine in a new clinical trial, the Cov-Boost study, led by University Hospital Southampton NHS Foundation Trust.
Backed by £19.3 million of government funding through the Vaccines Taskforce, the study will trial seven vaccines and will be the first in the world to provide data on the impact of a third dose on patients’ immune responses.
The study will take place at 16 NIHR-supported sites across England, and also within Health and Care Research Wales, and NHS Research Scotland sites. It will include a total of 2,886 patients and participants are to begin vaccinations from early June.
Health and Social Care Secretary, Matt Hancock, 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 part in protecting the most vulnerable people in this country and around the world for months and years to come.”
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. Vaccines being trialled include Oxford/AstraZeneca, Pfizer/BioNTech, Moderna, Novavax, Valneva, Janssen, and Curevac, as well as a control group.
All participants will be monitored throughout the study for any 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.
The initial findings are expected in September and will help inform decisions by the Joint Committee on Vaccination and Immunisation (JCVI) on plans for a booster programme from autumn this year.
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.”
So far in the UK, over 57.8 million vaccinations have been administered – 36.9 million first doses, which amounts to 7 in 10 UK adults being given one jab and 20.8 million second doses.
Earlier this year, the government announced the launch of the ComCov clinical trial, which aims to determine the effects of using different vaccines for the first and second dose – for example, using Oxford/AstraZeneca’s vaccine for the first dose, followed by Pfizer/BioNTech’s vaccine for the second.
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. Further results from this clinical trial – including on the immune response in people who have two different vaccine doses – are expected over the coming months.
Kat Jenkins
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