Covid19: the ISS launches two post-vaccination immunological monitoring studies in Italy

ISS, March 18th 2021 - The aim of two ISS studies is to monitor the immune response in the population. The first, in collaboration with the Società Italiana di Gerontologia e Geriatria (SIGG), is focused on elderly people residing in long-term care facilities (RSA – Residenze Sanitarie Assistenziali), and the second is targeted on a broader population segment comprising approximately 2,000 people.

Study on the general population

In order to study the vaccine-induced immune response, both of the “humoral” type, i.e. mediated by molecules circulating in the organism such as antibodies, and of the “cellular” type, the Istituto Superiore di Sanità – ISS (Italian National Institute of Health) has expedited a longitudinal multicentric study of healthy adults and frail older people vaccinated with different types of anti-COVID-19 vaccines. The monitoring will involve a sample of 2,000 individuals for each one of the vaccines currently available in the Country and will comprise two groups: relatively healthy subjects of between 30 and 65 years of age and frail persons over 65 (affected by at least two comorbidities).

13031. study will make it possible to monitor the vaccine-induced antibody response and the duration of its protection. The antibody titre will be measured at 1, 6, and 12 months after vaccination. At 12 months after the vaccination, a measurement will also be taken of the cell-mediated response. The data collected will provide information on the quantity and quality of the immune response induced by the different vaccines in adults and frail older people and, preliminarily, also on their efficacy in protecting against the infection and/or disease.

The research study was designed on the basis of the provisions contained in the document recently presented at Parliament on 2 December 2020 setting down the “Guidelines for the anti-SARS-CoV-2/COVID-19 Strategic Vaccination Plan” (Ministerial Decree of 2 January 2021), issued by the Ministry of Health, Extraordinary Commissioner’s Office for the Emergency, Istituto Superiore di Sanità, AgeNaS and AIFA, to meet the need to collect timely data on the antibody response and the immunological memory of people subjected to the anti-COVID-19 vaccine in order to provide information for the decision-makers of the National anti-SARS-CoV-2/COVID-19 Vaccination Plan. The study will be coordinated by the Infectious Disease Department of the ISS and will involve 8 University Hospitals located throughout the national territory: Azienda Ospedaliero-Universitaria Policlinico Umberto I, University of Rome La Sapienza;IRCCS Policlinico Ospedale Maggiore, Milan;Azienda Ospedaliero-Universitaria di Bologna IRCCS Policlinico di Sant’Orsola, University of Bologna;A.S.S.T. Ovest Milanese, Legnano (MI); Ospedale "Colonnello D'Avanzo" Policlinico Riuniti, Foggia; IRCCS Ospedale Policlinico San Martino, Genoa; Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone", Palermo; University of Padua, ULSS 6 Euganea, Padova; and, the Fondazione Bruno Kessler, Trento, for the sample design and the mathematical/statistical analyses.