Safety assessment
Adverse events (AEs) were reported using the Patient Clinical Questionnaire, focusing on local (injection-site reactions) and systemic (fever, headache, myalgia, and arthralgia) reactions and emergency medication (e.g., analgesic/antipyretics drugs). Pain intensity was self-assessed by patients on a 100-point visual analog scale (PGA-VAS). Severe AE (SAEs) was defined as acute conditions requiring hospital admission or urgent medical intervention followed by vaccination. Further, hematological, immunological, and biochemical parameters were measured using routine and standardized laboratory tests for safety assessment. All assessed parameters are listed in Supplementary Table 2.
Clinical outcomes
The primary outcome of vaccination was defined as the proportion of patients with CVID in whom SARS-CoV-2 infection was not confirmed by RT-PCR. RT-PCR testing was indicated in cases where respiratory-tract-infection symptoms were present or following risk contact with a SARS-CoV-2-positive person. Secondary efficacy was defined as COVID-19 severity in RT-PCR-positive patients with CVID, who were divided into four groups: asymptomatic, mild (symptomatic treatment only), moderate (antiviral drugs and/or anti-SARS-CoV-2 monoclonal antibodies), and severe (hospital admission).