National Project on Vaccines, COVID-19 and Frail Patients

For assessing the immunologic response to the COVID-19 vaccination, the anti-S antibodies levels in the fragile population will be quantified at T2 and compared with the anti-S antibodies levels quantified at the same time point in a population of healthy subjects.

for each time point, the anti-S antibodies levels will be quantified and compared with the anti-S antibodies levels quantified at the same time point in a population of healthy subjects (see controls).

At each time point, the Spike and N-specific T-cell immunity of the 1300 enrolled subjects will be assessed and compared to that observed in a population of healthy subjects at the same time point (see controls).

Subgroup analysis on the immunological response will be performed according to the clinical characteristics of the patients, the main diagnosis subgroups according to the eligibility criteria and the treatments they have received. we will compare the immune response with the different clinical characteristics of the patients

The impact on health status will be assessed through a questionnaire compiled at T1 and T2 by the physician before the blood sampling. The questionnaire will assess the occurrence of a list of symptoms in the week after the first and second administration of the vaccine.

The incidence of SARS-CoV-2 infection will be assessed in terms of number and proportion of patients who during the 52 weeks. SARS-CoV-2 infection will be assessed with: positive to molecular NF swab.