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A Severe Acute Respiratory Syndrome Coronavirus 2 Anti-Spike Immunoglobulin G Assay: A Robust Method for Evaluation of Vaccine Immunogenicity Using an Established Correlate of Protection.
Zhu, Mingzhu; Cloney-Clark, Shane; Feng, Sheau-Line; Parekh, Anand; Gorinson, Drew; Silva, David; Skonieczny, Paul; Wilson, Adjele; Kalkeri, Raj; Woo, Wayne; Cai, Miranda R; Fries, Louis; Glenn, Greg; Plested, Joyce S.
Afiliação
  • Zhu M; Clinical Immunology, Novavax, Inc., Gaithersburg, MD 20878, USA.
  • Cloney-Clark S; Clinical Immunology, Novavax, Inc., Gaithersburg, MD 20878, USA.
  • Feng SL; Clinical Immunology, Novavax, Inc., Gaithersburg, MD 20878, USA.
  • Parekh A; Clinical Immunology, Novavax, Inc., Gaithersburg, MD 20878, USA.
  • Gorinson D; Clinical Immunology, Novavax, Inc., Gaithersburg, MD 20878, USA.
  • Silva D; Clinical Immunology, Novavax, Inc., Gaithersburg, MD 20878, USA.
  • Skonieczny P; Clinical Immunology, Novavax, Inc., Gaithersburg, MD 20878, USA.
  • Wilson A; Clinical Immunology, Novavax, Inc., Gaithersburg, MD 20878, USA.
  • Kalkeri R; Clinical Immunology, Novavax, Inc., Gaithersburg, MD 20878, USA.
  • Woo W; Biostatistics, Novavax, Inc., Gaithersburg, MD 20878, USA.
  • Cai MR; Biostatistics, Novavax, Inc., Gaithersburg, MD 20878, USA.
  • Fries L; Clinical Development, Novavax, Inc., Gaithersburg, MD 20878, USA.
  • Glenn G; Discovery, Novavax, Inc., Gaithersburg, MD 20878, USA.
  • Plested JS; Clinical Immunology, Novavax, Inc., Gaithersburg, MD 20878, USA.
Microorganisms ; 11(7)2023 Jul 11.
Article em En | MEDLINE | ID: mdl-37512961
ABSTRACT
As the COVID-19 pandemic continues, variants of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continue to emerge. Immunogenicity evaluation of vaccines and identification of correlates of protection for vaccine effectiveness is critical to aid the development of vaccines against emerging variants. Anti-recombinant spike (rS) protein immunoglobulin G (IgG) quantitation in the systemic circulation (serum/plasma) is shown to correlate with vaccine efficacy. Thus, an enzyme-linked immunosorbent assay (ELISA)-based binding assay to detect SARS-CoV-2 (ancestral and variant strains) anti-rS IgG in human serum samples was developed and validated. This assay successfully met acceptance criteria for inter/intra-assay precision, specificity, selectivity, linearity, lower/upper limits of quantitation, matrix effects, and assay robustness. The analyte in serum was stable for up to 8 freeze/thaw cycles and 2 years in -80 °C storage. Similar results were observed for the Beta, Delta, and Omicron BA.1/BA.5/XBB.1.5 variant-adapted assays. Anti-rS IgG assay results correlated significantly with neutralization and receptor binding inhibition assays. In addition, usage of international reference standards allows data extrapolation to WHO international units (BAU/mL), facilitating comparison of results with other IgG assays. This anti-rS IgG assay is a robust, high-throughput method to evaluate binding IgG responses to S protein in serum, enabling rapid development of effective vaccines against emerging COVID-19 variants.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Prognostic_studies Idioma: En Revista: Microorganisms Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Estados Unidos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Prognostic_studies Idioma: En Revista: Microorganisms Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Estados Unidos