New trials of Italy's home-grown coronavirus vaccine are under way at a hospital in Pisa.
The drug, created by Rome-based biotech company ReiThera, showed promising results in initial testing last year.
The phase-two trial will enrol 900 participants in a placebo-controlled study at Pisa's University Hospital and will give participants either a single dose or a double dose with a three-week interval.
Doctors will monitor the drug's safety and efficacy before moving on to the next stage. It is hoped the vaccine will be available by September if it is approved by Italian pharmaceutical agency Aifa and European regulators.
The drug is based on a so-called non-replicating adenoviral vector, the same technology used in the Oxford-AstraZeneca and Johnson & Johnson vaccines.
Last year, an initial trial involving 45 volunteers, aged between 18 and 55, showed no serious side effects in the 28 days after the vaccination.
“Some 92.5 per cent of volunteers had detectable levels of neutralising antibodies,” said Giuseppe Ippolito, scientific director of Rome’s Lazzaro Spallanzani institute, which conducted the tests.
The Italian government invested heavily in ReiThera in the hope the drug would provide a viable alternative to other vaccines that are in short supply.
“If the data obtained so far is confirmed, in the coming months we will have an effective and safe vaccine with a single dose,” Italian Health Minister Roberto Speranza said in January.
ReiThera chairwoman Antonella Folgori previously said the company aimed to produce an annual 100 million doses, which can be stored temperatures of 2°C to 8°C.
Italy is relying entirely on a European Union joint procurement initiative for Covid-19 vaccines. The European Medicines Agency has approved four drugs – made by Johnson & Johnson, Pfizer-BioNTech, Moderna and Oxford-AstraZeneca.
In September, it was reported that the European Commission was in preliminary talks with ReiThera to buy the vaccine, but it is unclear if the two partners are still in negotiations.
On Wednesday, Italy reported 24,000 new coronavirus infections and 467 deaths, as Prime Minister Mario Draghi extended social restrictions until April 30.
Health bosses pledged to reach 500,000 daily inoculations in April from this week’s 230,000.
About 10 million doses have been administered since late December, with around 3.1 million of Italy's 60-million population receiving the recommended two shots.
