Abstract
Plasma-derived intravenous immunoglobulin (IVIg) products contain a dynamic spectrum of immunoglobulin (Ig) G reactivities reflective of the donor population from which they are derived. We sought to model the concentration of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) IgG which could be expected in future plasma pool and final-product batches of CSL Behring's immunoglobulin product Privigen. Data was extracted from accessible databases, including the incidence of coronavirus disease 2019 and SARS-CoV-2 vaccination status, antibody titre in convalescent and vaccinated groups and antibody half-life. Together, these parameters were used to create an integrated mathematical model that could be used to predict anti-SARS-CoV-2 antibody levels in future IVIg preparations. We predict that anti-SARS-CoV-2 IgG concentration will peak in batches produced in mid-October 2021, containing levels in the vicinity of 190-fold that of the mean convalescent (unvaccinated) plasma concentration. An elevated concentration (approximately 35-fold convalescent plasma) is anticipated to be retained in batches produced well into 2022. Measurement of several Privigen batches using the Phadia™ EliA™ SARS-CoV-2-Sp1 IgG binding assay confirmed the early phase of this model. The work presented in this paper may have important implications for physicians and patients who use Privigen for indicated diseases.
Highlights
Plasma-derived intravenous immunoglobulin (IVIg) products contain a dynamic spectrum of immunoglobulin (Ig) G reactivities reflective of the donor population from which they are derived
We predict that anti-SARS-CoV-2 immunoglobulin G (IgG) concentration will peak in batches produced in midOctober 2021, containing levels in the vicinity of 190-fold that of the mean convalescent plasma concentration
Measurement of several Privigen batches using the PhadiaTM EliATM SARS-CoV-2-Sp1 IgG binding assay confirmed the early phase of this model
Summary
Data extraction and grouping of donors by natural infection and vaccination status Literature and publicly available databases detailing COVID-19 prevalence, vaccination rate, anti-SARS-CoV-2 antibody peak titre and rate of decay (half-life) were interrogated for modelling purposes. Data was extracted for individuals aged 20–50 years who reside in the USA, since this age group and location best reflects the demographic of CSL Behring’s donor population. The donor population was divided into six groups representing possible combinations of infection and vaccination status as follows: donors naïve to COVID-19, who had received zero, one or two vaccine doses (groups 1–3), and donors who experienced a natural COVID-19 infection with the same vaccination statuses as above (groups 4–6). Each group was assigned an average anti-SARS-CoV-2 spike antibody concentration (AUC) based on the findings of Krammer et al [3] (S1 Table).
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