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LONDON – Johnson & Johnson launched a new, large-scale, late-stage trial on Monday to test a two-dose regimen of its experimental COVID-19 vaccine and evaluate the potential incremental benefits over the duration of protection with a second dose.
The US drugmaker plans to enroll up to 30,000 participants in the study and run it in parallel with a one-dose trial with up to 60,000 volunteers that began in September.
The UK arm of the study aims to recruit 6,000 participants with the remainder joining other countries with a high incidence of COVID-19 cases, including the United States, Belgium, Colombia, France, Germany, the Philippines, South Africa and Spain. , He said.
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 leading the trial. at Southampton University Hospital.
The trial follows positive interim results from the company’s ongoing early or mid-stage clinical study that showed that a single dose of its candidate vaccine induced a robust immune response and was generally well tolerated.
“The study will evaluate the efficacy of the investigational vaccine after the first and second doses to assess protection against the virus and the potential incremental benefits over the duration of protection with a second dose,” J&J said in a statement.
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 disease pandemic are ready for use soon.
READ: Keep hopes in check: vaccines seen in the Philippines by 2022 ‘realistically speaking’
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.
Recruitment for the study will be completed in March 2021 and the trial will last 12 months.
—Report from Kate Kelland; Editing by Jan Harvey and Richard Pullin
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