Severe Acute Respiratory Syndrome Corona Virus-2 (SARS-CoV-2) Serology in the Vaccination Era and Post Booster Vaccination
31 Pages Posted: 7 Jul 2022
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Severe Acute Respiratory Syndrome Corona Virus-2 (SARS-CoV-2) Serology in the Vaccination Era and Post Booster Vaccination
Severe Acute Respiratory Syndrome Corona Virus-2 (SARS-CoV-2) Serology in the Vaccination Era and Post Booster Vaccination
Abstract
Background: Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) pandemic has caused over 6 million deaths world-wide. In the pre-vaccination era, we noted a 5·3% SARS-CoV-2 IgG antibody positivity rate in 81,624 subjects.
Methods: Utilizing assays for serum SARS-CoV-2 spike (S) protein antibody (Roche) and neutralizing antibody (Diazyme), both >90% IgG, we measured antibodies in 13,189 subjects in the post-vaccination era, and in 69 subjects before and 60 days after booster vaccination.
Results: In 2021, in 10,267 subjects, 25·0% had negative S protein levels (<0.80 U/L), 24·4% had low positive levels (0.80-250 U/L), and 50·7% had high positive levels (>250 U/L). Median neutralizing antibody levels were 1·16 and 2·06 AU/mL in the low and high positive groups, respectively. In 2022, we evaluated 2,016 subjects where samples were diluted 1:100 if S protein antibody levels were >250 U/L. Median S protein and neutralizing antibody levels were 2,065 U/L (86.3% positivity) and 2·68 AU/mL (68.0% positivity), respectively. Antibody levels were also measured in 69 subjects before and 60 days after receiving SARS-CoV-2 booster vaccinations. Treatment resulted in a 15-fold increase in S protein antibody levels from 1,010 to 17,236 U/L, and a 6-fold increase in neutralizing antibody from 1·51 to 12·51 AU/mL in neutralizing antibody levels, respectively (both P <0.00001), with a wide variability in response.
Conclusions: Our data indicate that by early 2022 86% of subjects had positive SARS-CoV-2 S protein antibody levels, and that these levels and neutralizing antibody levels were increased 15-fold and 6-fold, respectively, 60 days after SARS-Cov-2 booster vaccination.
Note:
Funding Information: This study was supported by funds from Trinity Health Of New England, a not-for-profit healthcare organization and Boston Heart Diagnostics.
Declaration of Interests: The authors declare that they have no competing interests.
Ethics Approval Statement: This type of research is exempted from requirement for human institutional review board (IRB) approval as per exemption 4, as listed at https://grants.nih.gov/policy/ humansubjects.htm and at the open education resource (OER) website for research involving human subjects. This exemption “involves the collection or study of data or specimens if publicly available or recorded such that subjects cannot be identified”. We had this designation and our research reviewed by the Advarra Institutional Review Board (Columbia, MD). They determined that this research met the criteria for exemption from institutional review board review under 45 CFR 46.104(d)” and, therefore, ruled that this research did not require IRB approval.
Keywords: SARS-CoV 2, Pre booster and post booster serology, S Protein Antibodies, Neutralizing Antibodies
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