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August 24, 2020 Thousands had applied to test the Italian vaccine. And finally the long-awaited day has arrived: from today experimentation comes alive.

 "Today the first Italian, the first volunteer undergoes vaccine testing. I am very satisfied and proud of this," Francesco Vaia, health director of Spallanzani in Rome, told 'Uno Mattina estate' on Raiuno.       

"If all goes well and we finish this trial within the year and if we're good and fast now, we could have the vaccine by next spring on a commercial basis. That's the prediction," Vaia said.

"The classic phase one is thus inaugurated - he declared - which will have to verify whether the vaccine dose will not give side effects to the patient and, above all, if this dose is immunogenic, that is, if it is capable of producing the creation of antibodies. Antibodies that must be neutralized, that is, capable of blocking viral replication. After that the citizens subjected to the experiment, until the autumn, will be observed for 12 weeks. The second and third phases involve experimentation in countries in countries where virulence it is much higher than in Italy, like Brazil or Mexico ", concluded Vaia.  

The protocol
The trial will be conducted at the National Institute for Infectious Diseases "L. Spallanzani" in Rome and the Verona Clinical Research Center. This is a phase one study that aims to evaluate the safety and immunogenicity of the GRAd-COV2 vaccine, based on an adenoviral vector and targeting the Coronavirus 2 responsible for severe acute respiratory syndrome (SARS-CoV-2 ). GRAd-COV2 has been shown to be sufficiently safe and immunogenic in animal models, Aifa says. The adult cohort will enroll 45 healthy subjects between the ages of 18 and 55. The cohort of seniors will enroll 45 healthy subjects between the ages of 65 and 85. Both cohorts are defined to have three escalating three-dose treatment arms consisting of 15 participants each, for a total of 6 groups. Enrollment will start from cohort 1 and will proceed sequentially, after verifying the safety data at the different steps. The vaccine development project is supported by the Ministry of Research with the CNR and by the Lazio Region.