The UK has launched a new clinical trial to assess the effect of a third ‘booster’ dose of seven different Covid-19 vaccines on patients’ immune responses.
Named Cov-Boost, the trial is led by University Hospital Southampton NHS Foundation Trust with £19.3m funding from the UK Government.
It will be conducted at 16 sites in England including University Hospital Southampton, University Hospitals Dorset, and the Portsmouth Research Hub.
The trial is said to be the first in the world to gather data on the third dose’s effect on immune responses. Researchers aim to gain insights into the effectiveness of a booster vaccine dose in protecting against the Covid-19 virus.
In addition to Oxford-AstraZeneca vaccine, the trial will assess Covid-19 vaccines of Pfizer-BioNTech, Moderna, Novavax, Valneva, Janssen and Curevac. A control group will also be part of the trial.
The plan is to involve a total of 2,886 patients aged 30 years and above, with vaccinations scheduled to begin next month.
A third booster vaccine dose will be administered after a minimum of 10 to 12 weeks from a second dose. The booster given to a participant may be different from their original vaccination brand.
All subjects will be observed for any side effects and their blood samples are to be analysed for immune responses at days 28, 84, 308 and 365.
Expected to be available in September, the initial trial data will be reviewed by the Joint Committee on Vaccination and Immunisation (JCVI) to decide on a booster programme in the country this year.
Southampton Clinical Research Facility chief investigator 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.”
Commissioned by the UK Department of Health and Social Care via the National Institute for Health Research (NIHR), the trial secured the NHS Research Ethics Committee and the Medicines and Healthcare products Regulatory Agency approvals.
In March this year, the UK announced the HEAL-COVID trial to find drugs to reduce deaths and hospital readmissions among patients who are recovering after being treated for Covid-19.