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).