The ReiThera vaccine, called GRAd-COV2, produced an antibody response in over 93% of volunteers three weeks after the first dose, reaching 99% after the second shot, the company based in Castel Romano near Rome said in a statement on Monday.
ReiThera stated that the results “confirmed what was already observed during Phase 1: the vaccine is well tolerated in the first dose and even better tolerated after the second.”
“Adverse events, for the most part of a small or moderate entity and of short duration, are mainly referable to pain and tension at the site of the injection, sense of fatigue, muscular pain and headache”, the company went on to say.
“No serious adverse events that could be connected to the vaccine were registered”, it said.
The study, which began on March 18th in 24 clinical centers across Italy, involved 917 volunteers, the company said.
The volunteers were divided at random into three groups, receiving either a single vaccine dose followed by a placebo dose, or two vaccine doses, or two doses of placebo, with a three-week interval in between.
ReiThera said two independent advisory boards had recommended advancing the vaccine into the third and final phase of trials, but it was unclear how this may be funded.
The company would need at least 60 million euros ($71 million) for the third phase of studies, but an Italian state audit court recently rejected plans to give it public funding, Reuters reported.
ReiThera has held preliminary talks about potentially supplying its vaccine to the European Union, which is looking to boost its own production of vaccines.
Italy’s coronavirus special commissioner said this week that a higher rate of vaccinations is needed in a new “push” to increase coverage, particularly of people in older, more vulnerable age groups.
The country is currently administering around half a million Covid-19 vaccine doses per day.