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1 Department of Cardiology, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA.
2 Applied Research and Technology, Abbott Diagnostics, Lake Forest, Illinois, USA.
3 Inflammatory Bowel and Immunobiology Research Institute, Karsh Division of Digestive and Liver Diseases, Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, California, USA.
4 Comprehensive Transplant Center, Department of Medicine, Division of Nephrology, Cedars-Sinai Medical Center, Los Angeles, California, USA.
5 Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts, USA.
6 Department of Pathology and Laboratory Medicine, Cedars-Sinai Medical Center, Los Angeles, California, USA.
1 Department of Cardiology, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA.
2 Applied Research and Technology, Abbott Diagnostics, Lake Forest, Illinois, USA.
3 Inflammatory Bowel and Immunobiology Research Institute, Karsh Division of Digestive and Liver Diseases, Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, California, USA.
4 Comprehensive Transplant Center, Department of Medicine, Division of Nephrology, Cedars-Sinai Medical Center, Los Angeles, California, USA.
5 Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts, USA.
6 Department of Pathology and Laboratory Medicine, Cedars-Sinai Medical Center, Los Angeles, California, USA.
JCP, ECF, and JLS work for Abbott Diagnostics, a company that performed the serological assays on the biospecimens that were collected for this study. GYM reports consulting fees from Abbvie, Arena, Boehringer-Ingelheim, Bristol-Myers Squibb, Gilead, Janssen, Fresenius Kabi, Ferring, Merck, Pfizer, Prometheus Labs, Samsung Bioepis, Shionogi, Techlab, and Takeda; advisory or leadership roles with Bristol-Myers Squibb, Redhill Biopharma; and, royalties/licenses and patents planned, issued, or pending via Aytu Biosciences. KS has received speaking honoraria from Abbott Diagnostics and served as a consultant for Sapient Bioanalytics, a company that supported the collection and processing of samples for this study. The remaining authors have no relevant potential conflicts.
Figures
Figure.. Cohort characteristics associated with longitudinal anti-spike…
Figure.. Cohort characteristics associated with longitudinal anti-spike IgG antibody response.
The distribution of cohort characteristics…
Figure.. Cohort characteristics associated with longitudinal anti-spike IgG antibody response.
The distribution of cohort characteristics and their multivariable-adjusted associations with longitudinal anti-spike IgG antibody response following vaccination are shown in Panel A. The primary mixed-effects linear regression model accounts for individual-level repeated measures as random effects and is adjusted for all the characteristics shown in the table above in addition to the number of serology samples collected per participant, year of cohort enrollment, type of vaccine dose, and interactions between the additional vaccine dose number (i.e. 1st or 2nd booster) and the time between when the dose was given and the time of IgG-S measurement. In Panels B-E, the longitudinal anti-spike IgG antibody response, indexed from the date of initial vaccination with estimates and 95% confidence interval, is shown with adjustment for demographic, clinical, and COVID exposure factors and derived from the model shown in Panel A. Over the full ~2.2 year surveillance period, differences by sex (Panel B) and age (Panel C) were no longer apparent while differences by number of vaccine doses received (Panel D) and presence of immunocompromising conditions such solid organ transplant (Panel E) emerged as statistically significant. As shown in Panel D, following an initial vaccine regimen, the IgG-S response level was over 2252 AU/mL (320 BAU/mL) for over 90% of our overall study population at 10-14 weeks, and over 698 AU/mL (99 BAU/mL) at 22-26 weeks and over 304 AU/mL (43 BAU/mL) at 34-38 weeks; these values are well above the threshold for positivity set at 50 AU/mL (7.1 BAU/mL) for the assay used. Of note, the latter threshold is not specific to a measure of immunity, nor a correlate of protection; for reference, the approved “high-titer” convalescent plasma threshold is 1280 AU/mL (182 BAU/mL) for the same assay. In context, when compared to longitudinal IgG-S response range observed in the overall population after initial vaccination, 87% of the solid organ transplant recipients who received a 2nd booster vaccine dose were noted to have IgG-S values >2252 AU/mL at 10-14 weeks following their 2nd booster vaccine dose (i.e. similar in range to the overall population after initial vaccination).
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