Johnson & Johnson launched a new late-stage trial in Britain on Monday to test a two-dose regimen of its experimental Covid-19 vaccine among thousands of volunteers, as the US drugmaker broadens its trials by geography and type.
The British arm of the study aims to recruit 6,000 participants from a total of 30,000 people worldwide, said the scientists leading the trial in the United Kingdom. Volunteers will be recruited at 17 sites across the UK.
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They will be given a first dose of a placebo or the experimental injection, currently called Ad26COV2, followed by a second dose or a placebo 57 days later, said Saul Faust, a professor of pediatric immunology and infectious diseases who is co-leading the trial. at Southampton University Hospital.
J&J signed an agreement for the global two-dose phase III clinical trial with the British government in August, which will run in parallel with a 60,000-person trial of a single injection of the experimental vaccine that was launched in September.
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If the results of the single injection test are positive, the company said it could simplify the distribution of millions of doses compared to major rivals that require two doses. The effectiveness of a double dose vaccine could be affected if people do not return for a second injection.
Rival drug makers Pfizer and BioNtech said last week that their potential Covid-19 injection showed more than 90% efficacy in interim data from a late-stage trial, raising hopes that vaccines against the pandemic disease are ready for use soon.
While the Pfizer-BioNtech vaccine uses a new technology known as messenger RNA, J & J’s uses a cold virus to deliver coronavirus genetic material to the body and elicit an immune response.
The platform, called AdVac, is also used in an Ebola vaccine that was approved earlier this year.
“It’s really important that we test a lot of different vaccines from a lot of different manufacturers and we can secure supply both to the UK and to the world population,” Faust told reporters at a briefing.
The scientists who led the trial in the UK did not give details of the other countries that would be involved in this two-dose trial, but said Britain is the first place to start it. Recruitment for the study will be completed in March 2021 and the trial will last 12 months.
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