Covid vaccine: Major new trial starts in UK
Researchers will recruit 6,000 volunteers to take part in study
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US pharmaceutical giant Johnson & Johnson (J&J) is today launching a UK-based trial of its experimental coronavirus vaccine.
A subsidiary of J&J, Janssen, will trial the jab on 6,000 UK volunteers in two doses, in a phase three trial. These trials are generally the last step before companies approach regulators for approval to begin rolling out medicines to the general public.
The jab has already undergone phase one and two trials in its single-dose study. So far, data suggest the Covid vaccine candidate induces a robust immune response and is generally well-tolerated by hosts.
For the new phase, researchers will invite volunteers from major UK cities including Southampton, Bristol, Cardiff, London, Leicester, Sheffield, Manchester, Dundee and Belfast to partake in the study. Recruitment into the final stage of the trial will be completed by March 2021, the trial itself will then take around 12 months.
Janssen’s jab is an adenoviral vaccine — the same as the one Oxford University is currently working to produce.
With these vaccines, an adenovirus vector is used to transport immunising proteins into the recipient’s body. Adenoviruses are a group of viruses that typically infect membranes of the eyes, respiratory tract, urinary tract, intestines and nervous system. The common cold is an adenovirus.
According to the news-medical website, adenovirus-based vaccines are advantageous because they are easy to manipulate genetically. They are also thought to be one of the safest jab options because they come with very few side effects.
Around 25,000 people in the UK have so far participated in Covid vaccine trials, with an additional 310,000 said to be willing to take part in future clinical studies, based on figures from the NHS vaccine research registry.
The Janssen vaccine will be the third jab to be trialled in the UK so far, after the Oxford/AstraZeneca candidate and one from US biotech company Novavax.
Saul Faust, professor of paediatric immunology and infectious diseases at the University of Southampton, told the PA news agency: “We just don't know how each of these vaccines is going to behave and which are going to generate the better short and long-term immunity.
“And we can't be certain that vaccine supply will be efficient and effective and secure from any one manufacturer, wherever it's being made in the world.”
The UK has secured 30 million doses of the Janssen vaccine should the trial be a success.
Prof Faust, who is principal investigator of the Janssen trial in the UK, said there are 40,000 people on the NHS vaccine registry who are in the postcode areas around the vaccine centres for the Janssen study. They will be contacted in the second half of this week and invited to take part in the study.
He said: “It is going to be some time before the bulk of the population receive a coronavirus vaccine just because of the technical difficulties of manufacturing, achieving the number of vaccines in the UK, and then deployment in that many people.”
Janssen’s researchers have said results of the study will depend on how swiftly people are recruited in to the trial. Recent vaccine trials suggest it takes six to nine months to get an outcome but it could be longer.
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