[HTML][HTML] Predicting the protective humoral response to a SARS-CoV-2 mRNA vaccine

S Meschi, G Matusali, F Colavita, D Lapa… - Clinical Chemistry and …, 2021 - degruyter.com
S Meschi, G Matusali, F Colavita, D Lapa, L Bordi, V Puro, BD Leoni, C Galli…
Clinical Chemistry and Laboratory Medicine (CCLM), 2021degruyter.com
Objectives Simple and standardized methods to establish correlates to vaccine-elicited
SARS-CoV-2 protection are needed. Methods An observational study on antibody response
to a mRNA vaccine (Comirnaty) was performed on health care workers (V, n= 120).
Recovered COVID-19 patients (N, n= 94) were used for comparison. Antibody response was
evaluated by a quantitative anti-receptor binding domain IgG (anti-RBD) commercial assay
and by virus microneutralization test (MNT), in order to establish a threshold of anti-RBD …
Abstract
Objectives
Simple and standardized methods to establish correlates to vaccine-elicited SARS-CoV-2 protection are needed.
Methods
An observational study on antibody response to a mRNA vaccine (Comirnaty) was performed on health care workers (V, n= 120). Recovered COVID-19 patients (N, n= 94) were used for comparison. Antibody response was evaluated by a quantitative anti-receptor binding domain IgG (anti-RBD) commercial assay and by virus microneutralization test (MNT), in order to establish a threshold of anti-RBD binding antibody units (BAU) able to predict a robust (≥ 1: 80) MNT titer.
Results
Significant correlation between BAU and MNT titers was found in both V and N, being stronger in V (rs= 0.91 and 0.57 respectively, p< 0.001); a higher incremental trend starting from MNT titer 1: 80 was observed in the V group. The 99% probability of high MNT titer (≥ 1: 80) was reached at 1,814 and 3,564 BAU/mL, and the area under the receiver operating characteristic (ROC) curve was 0.99 (CI: 0.99–1.00) and 0.78 (CI: 0.67–0.86) in V and N, respectively.
Conclusions
A threshold of 2,000 BAU/mL is highly predictive of strong MNT response in vaccinated individuals and may represent a good surrogate marker of protective response. It remains to be established whether the present results can be extended to BAU titers obtained with other assays.
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