Immunogenicity, safety and efficacy in the CVID patients -Data from the 6-month prospective study

ABSTRACT

Background: A single-stranded mRNA virus SARS-CoV- 2 is associated with severe acute respiratory syndrome in the predisposed individuals such as elderly, obese, chronic cardiovascular or pulmonary diseases. Higher risk for severe course was also reported in inborn errors of immunity (IEI). While restriction measures play important role from the short-term perspective, vaccination may provide long-term protection. However, only limited data are available on safety and efficacy in immunocompromised patients with IEI such as Common variable immunodeficiency (CVID). Method(s) We assessed humoral and cellular responses, safety and efficacy in a cohort of 20 CVID patients after 2 doses of anti-SARS- CoV- 2 vaccine BNT162b. The humoral reponse was evaluated using ELISA and western blot methods, the T cell response measured by IFNg secretion functional assay. Adverse events were reported by Patient Clinical Questionnaire. Blood count, biochemical, coagulation and immunological parameters were checked before and after vaccination. The patients were followed for 6 months. Result(s) Despite severely impaired antibody production hunoral response was detected in 48% (n = 10/21) of patients at month 1. However, the response persisted in only 33% (n = 6/18) at month 3 and further decreaed to 13% (n = 2/15) at month 6. The T cell response was measurable in 5 patients (28%) at month 1. In total, 4 out of 20 (20%) patients got infected within the study period. None of them required oxygenotherapy or hospital admission. We did not observe any severe adverse effects beyond local pain, fatigue, headche, fever, arthralgia and myalgia. Conclusion(s) Vaccination with mRNA vaccine BNT162b provides safe and effective protection for a subgroup of CVID patients. However, the immunogenicity is lower compared to the general population.