The study, promoted and encouraged directly by Rectress Antonella Polimeni, and by the director-general of the Policlinico Umberto I, Fabrizio d'Alba, will include about 10,000 subjects and will aim to assess the antibody response in vaccinated subjects and to analyse how the type of reaction is associated with important variables such as age, sex, the presence of comorbidities and socio-economic conditions.

All care units and academics will be involved to develop a research network encompassing all facilities of Europe's largest general hospital. 

Adverse events after vaccination will also be recorded in all subjects. The aim is to assess the quantity and quality of the anti-Spike immune response induced by the vaccination and follow the dynamics of the eventual infection and the protective efficacy of the vaccine simultaneously, by measuring the titre of antibodies against the nucleoprotein (N), specific to the natural infection. 

All 10,000 subjects will also be assessed 6 and 12 months after the start of vaccination. The  Italian National Institute of Health will collaborate in the study and look for possible viral variants in potential infection after vaccination.

At present, 5,000 workers have been vaccinated, ranging from auxiliary staff members to residents, who will represent the immediate study population.  The second round of vaccinations, which will also include a pre-vaccination analysis, will begin shortly.

For Sapienza and Policlinico Umberto I, this study represents a virtuous model of how excellence in healthcare and research can come together in a joint project that aims to combat the pandemic, as demonstrated over this long period, but also to develop joint research strategies.