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. 2023 Feb 2;61(7):1343-1348.
doi: 10.1515/cclm-2023-0055. Print 2023 Jun 27.

Assessment of humoral and cellular immunity after bivalent BNT162b2 vaccination and potential association with reactogenicity

Gian Luca Salvagno  1   2 , Laura Pighi  1   2 , Brandon M Henry  3 , Myriam Valentini  2 , Beatrice Tonin  4 , Damiano Bragantini  5 , Gianluca Gianfilippi  4 , Simone De Nitto  1   2 , Mario Plebani  6 , Giuseppe Lippi  1
Affiliations

Assessment of humoral and cellular immunity after bivalent BNT162b2 vaccination and potential association with reactogenicity

Gian Luca Salvagno et al. Clin Chem Lab Med. .

Abstract

Objectives: This study investigated the feasibility and clinical value of using a novel, automated and high-throughput SARS-CoV-2 Interferon Gamma Release Assay (IGRA), combined with total anti-SARS-CoV-2 antibodies assessment, for evaluating the immune response after bivalent BNT162b2 vaccination.

Methods: A cohort of healthcare workers, who already underwent primary vaccination and boosting with monovalent BNT162b2 vaccine, received a booster dose of the new BNT162b2 bivalent formulation. Blood samples were taken immediately before vaccination (T0) and 1 month afterwards (T1). Humoral and cellular immunity were assayed with Roche Elecsys Anti-SARS-CoV-2 and Roche Elecsys IGRA SARS-CoV-2, respectively.

Results: The study population consisted of 51 subjects (median age: 43 years; 51% females). Total anti-SARS-CoV-2 antibodies and IGRA SARS-CoV-2 values increased at T1 from 9,050 to 25,000 BAU/mL (p<0.001), and from 0.44 to 0.78 IU/mL (p=0.385), accounting for median increase of 2.0 and 1.6 folds, respectively. Increased T1 values of total anti-SARS-CoV-2 antibodies and IGRA SARS-CoV-2 were recorded in 100% and 68.6% subjects, respectively. In those with baseline values below the median, post-vaccine levels displayed larger increases of 3.3 and 5.1 folds for anti-SARS-CoV-2 total antibodies and IGRA SARS-CoV-2, respectively. The variation of total anti-SARS-CoV-2 antibodies was inversely associated with their T0 values (r=-0.97; p<0.001), whilst that of IGRA SARS-CoV-2 was inversely associated with its T0 value (r=-0.58; p<0.001). No other signifcant associations were found with demographical or clinical variables, including side effects.

Conclusions: The bivalent BNT162b2 vaccine booster enhances humoral and cellular immunity against SARS-CoV-2, especially in recipients with lower baseline biological protection.

Keywords: COVID-19; SARS-CoV-2; antibodies; immunity; interferon gamma release assay; vaccination.

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