Prospective study of humoral and cellular immune response to the COVID-19 vaccines in patients with Inborn errors of immunity (IEI)

Abstract

Background: Inborn Errors of Immunity (IEI), or Primary Immunodeficiencies, comprise a vast group of genetic diseases, with a wide spectrum of phenotypes and diverse altered components of the innate and/or adaptive immune system. Mass vaccination against SARS-CoV-2 has proven to be extremely successful, with the potential to control the COVID-19 pandemic and prevent severe disease. IEI patients do not develop an immune response to vaccines similar to an immunocompetent individual, making different immunization schemes necessary in this population, such as the administration of booster doses. In this context, it is essential to assess the presence and duration of the immune response against SARS-CoV-2 induced after booster doses of COVID-19 vaccines in use in patients with IEI. Objective: To analyze the development and the duration of the specific humoral and cellular immune response induced in the 12 months following the booster doses of COVID-19 vaccines in use in patients with IEI. Methods: Individuals with IEI (n=60) immunized against COVID-19 (20 with CoronaVac, 20 with AstraZeneca and 20 with Pfizer) and third dose for at least 28 to 42 days will be included, with blood samples collected at 1 and 3 months after the third dose and at 6 and 12 months after the fourth dose (booster dose) and monthly monitoring of SARS-CoV-2 infection. The control group will have 60 healthy participants also immunized against COVID-19 (20 with CoronaVac, 20 with AstraZeneca and 20 with Pfizer), who also will be included in the period from 28 to 42 days after the booster dose, with blood samples after 1, 3 and 6 months after the third dose (booster dose). If there is a fourth dose for the general population in the National Immunization Program (PNI) in this period, the last blood samples will be at 1 and 6 months after the fourth dose. In both groups, the lymphocyte profile will be assessed by flow cytometry. SARS-CoV-2 humoral immunity will be assessed by an enzyme immunoassay and cellular immunity, by the ELISPot. Vaccine immune response to SARS-CoV-2 will be investigated taking into consideration the groups of participants, the COVID-19 vaccine administered and the history of previous infection by SARS-CoV-2. (AU)