Volunteers in Italy will receive the first doses from December 1, as scientists begin a Phase 3 clinical trial of the vaccine developed by Oxford University and AstraZeneca pharmaceutical group and partly manufactured and bottled by two Italian companies near Rome.
The vaccine, one of several in development around the world, is among the most advanced, with a large-scale trial already underway on as many as 10,000 people in the UK.
The two-year Italian trial will be carried out by seven institutions starting with the University Hospital of Modena, in the northern region of Emilia-Romagna.
Researchers are seeking 300 volunteers aged 18 and over, who are not pregnant or immunosuppressed, and have not already contracted a severe case of the virus.
The volunteers will be subjected to double-blind tests, the hospital said on Wednesday.
Only 200 of them will receive the experimental vaccine, with the remaining 100 getting a placebo.
Neither subjects nor researchers will be informed which one each volunteer gets until the study is complete.
Participants will receive two doses and be subjected to periodic blood and health checks over a total of two years, though the first results of the study are expected to be announced after six months.
The hospital plans to set up a dedicated phone hotline to collect applications throughout November, with spots going to the first 300 people who volunteer and meet the selection criteria.
Phase 3 trials are the final tests before regulators decide whether to approve a drug.
The head of Italy’s Higher Health Institute, Walter Locatelli, has said the first doses could be available in spring 2021.
The new trial is separate from an early-stage trial underway in Rome, where researchers at the Spallanzani National Institute for Infectious Diseases are testing a different vaccine developed by Italian biotech company ReiThera on a much smaller sample of volunteers.
