Safety
AEs were reported in 90% (n=19/21) of patients with CVID after the
first and second doses. The most common event was local pain at the
injection site (20/21), followed by fatigue (10/21), headache (7/21),
fever (5/21), myalgia (3/21), and arthralgia (2/21) after the first
dose. A similar AE spectrum was observed after the second dose. AE
incidence is summarized in Fig 4. AE mean durations after the first and
second doses were 3.55 (±2.19 SD) and 2.95 (±2.04) days, respectively.
PGA-VAS-100 was 18.25 (±21.96) and 16.75 (±22.38) points. We also
evaluated a broad spectrum of laboratory parameters, including
biochemical, hematological, immunological, and inflammatory parameters.
We detected significantly increased soluble CD25 levels after both
vaccine doses. No changes in the total blood count, liver or renal
function, and coagulation were observed, and no autoantibodies were
detected during the follow-up period. Vaccination did not increase
inflammatory markers, except for soluble IL-2R (sCD25) levels, which
were significantly increased after both vaccine doses. A complete
overview of these parameters is provided in Supplementary Table 1.