Cargando…

30-Minute Highly Multiplexed VaxArray Immunoassay for Pneumococcal Vaccine Antigen Characterization

Pneumonia accounts for over 20% of deaths worldwide in children aged 1 to 5 years, disproportionately affecting lower- and middle-income countries. Effective, highly multivalent pneumococcal vaccines are available to decrease disease burden, with numerous new vaccines currently under development to...

Descripción completa

Detalles Bibliográficos
Autores principales: Hu, Tianjing, Miller, David F., Taylor, Amber W., Riley, Christine, McCormick, Caitlin, Thomas, Keely N., Gao, Rachel Y., Rowlen, Kathy L., Byrne, Emilia B., Kumar, Pardeep, Kim, Soo Kyung, Dawson, Erica D.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9693921/
https://www.ncbi.nlm.nih.gov/pubmed/36423058
http://dx.doi.org/10.3390/vaccines10111964
_version_ 1784837665859829760
author Hu, Tianjing
Miller, David F.
Taylor, Amber W.
Riley, Christine
McCormick, Caitlin
Thomas, Keely N.
Gao, Rachel Y.
Rowlen, Kathy L.
Byrne, Emilia B.
Kumar, Pardeep
Kim, Soo Kyung
Dawson, Erica D.
author_facet Hu, Tianjing
Miller, David F.
Taylor, Amber W.
Riley, Christine
McCormick, Caitlin
Thomas, Keely N.
Gao, Rachel Y.
Rowlen, Kathy L.
Byrne, Emilia B.
Kumar, Pardeep
Kim, Soo Kyung
Dawson, Erica D.
author_sort Hu, Tianjing
collection PubMed
description Pneumonia accounts for over 20% of deaths worldwide in children aged 1 to 5 years, disproportionately affecting lower- and middle-income countries. Effective, highly multivalent pneumococcal vaccines are available to decrease disease burden, with numerous new vaccines currently under development to serve a variety of worldwide markets. However, pneumococcal conjugate vaccines are among the hardest biologics to manufacture and characterize due to their complexity and heterogeneity. Current characterization methods are often inherently singleplex, requiring separate tests for each serotype present. In addition, identity and quantity are often determined with separate methods. We developed the VaxArray pneumococcal assay for applications in identity, quantity, and stability testing of pneumococcal polysaccharide and pneumococcal conjugate vaccines. The VaxArray pneumococcal assay has a time to result of less than 30 min and is an off-the-shelf multiplexed, microarray-based immunoassay kit that can identify and simultaneously quantify 23 pneumococcal polysaccharide serotypes common to many on-market and in-development vaccines. Here, we highlight the potential of the assay for identity testing by showing high reactivity and serotype specificity to a wide variety of native polysaccharides, CRM197-conjugated polysaccharides, and drug product. The assay also has vaccine-relevant lower limits of quantification in the low-to-mid ng/mL range and can be used for accurate quantification even in adjuvanted vaccines. Excellent correlation to the anthrone assay is demonstrated, with VaxArray resulting in significantly improved precision over this antiquated chemical method.
format Online
Article
Text
id pubmed-9693921
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher MDPI
record_format MEDLINE/PubMed
spelling pubmed-96939212022-11-26 30-Minute Highly Multiplexed VaxArray Immunoassay for Pneumococcal Vaccine Antigen Characterization Hu, Tianjing Miller, David F. Taylor, Amber W. Riley, Christine McCormick, Caitlin Thomas, Keely N. Gao, Rachel Y. Rowlen, Kathy L. Byrne, Emilia B. Kumar, Pardeep Kim, Soo Kyung Dawson, Erica D. Vaccines (Basel) Article Pneumonia accounts for over 20% of deaths worldwide in children aged 1 to 5 years, disproportionately affecting lower- and middle-income countries. Effective, highly multivalent pneumococcal vaccines are available to decrease disease burden, with numerous new vaccines currently under development to serve a variety of worldwide markets. However, pneumococcal conjugate vaccines are among the hardest biologics to manufacture and characterize due to their complexity and heterogeneity. Current characterization methods are often inherently singleplex, requiring separate tests for each serotype present. In addition, identity and quantity are often determined with separate methods. We developed the VaxArray pneumococcal assay for applications in identity, quantity, and stability testing of pneumococcal polysaccharide and pneumococcal conjugate vaccines. The VaxArray pneumococcal assay has a time to result of less than 30 min and is an off-the-shelf multiplexed, microarray-based immunoassay kit that can identify and simultaneously quantify 23 pneumococcal polysaccharide serotypes common to many on-market and in-development vaccines. Here, we highlight the potential of the assay for identity testing by showing high reactivity and serotype specificity to a wide variety of native polysaccharides, CRM197-conjugated polysaccharides, and drug product. The assay also has vaccine-relevant lower limits of quantification in the low-to-mid ng/mL range and can be used for accurate quantification even in adjuvanted vaccines. Excellent correlation to the anthrone assay is demonstrated, with VaxArray resulting in significantly improved precision over this antiquated chemical method. MDPI 2022-11-19 /pmc/articles/PMC9693921/ /pubmed/36423058 http://dx.doi.org/10.3390/vaccines10111964 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Hu, Tianjing
Miller, David F.
Taylor, Amber W.
Riley, Christine
McCormick, Caitlin
Thomas, Keely N.
Gao, Rachel Y.
Rowlen, Kathy L.
Byrne, Emilia B.
Kumar, Pardeep
Kim, Soo Kyung
Dawson, Erica D.
30-Minute Highly Multiplexed VaxArray Immunoassay for Pneumococcal Vaccine Antigen Characterization
title 30-Minute Highly Multiplexed VaxArray Immunoassay for Pneumococcal Vaccine Antigen Characterization
title_full 30-Minute Highly Multiplexed VaxArray Immunoassay for Pneumococcal Vaccine Antigen Characterization
title_fullStr 30-Minute Highly Multiplexed VaxArray Immunoassay for Pneumococcal Vaccine Antigen Characterization
title_full_unstemmed 30-Minute Highly Multiplexed VaxArray Immunoassay for Pneumococcal Vaccine Antigen Characterization
title_short 30-Minute Highly Multiplexed VaxArray Immunoassay for Pneumococcal Vaccine Antigen Characterization
title_sort 30-minute highly multiplexed vaxarray immunoassay for pneumococcal vaccine antigen characterization
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9693921/
https://www.ncbi.nlm.nih.gov/pubmed/36423058
http://dx.doi.org/10.3390/vaccines10111964
work_keys_str_mv AT hutianjing 30minutehighlymultiplexedvaxarrayimmunoassayforpneumococcalvaccineantigencharacterization
AT millerdavidf 30minutehighlymultiplexedvaxarrayimmunoassayforpneumococcalvaccineantigencharacterization
AT tayloramberw 30minutehighlymultiplexedvaxarrayimmunoassayforpneumococcalvaccineantigencharacterization
AT rileychristine 30minutehighlymultiplexedvaxarrayimmunoassayforpneumococcalvaccineantigencharacterization
AT mccormickcaitlin 30minutehighlymultiplexedvaxarrayimmunoassayforpneumococcalvaccineantigencharacterization
AT thomaskeelyn 30minutehighlymultiplexedvaxarrayimmunoassayforpneumococcalvaccineantigencharacterization
AT gaorachely 30minutehighlymultiplexedvaxarrayimmunoassayforpneumococcalvaccineantigencharacterization
AT rowlenkathyl 30minutehighlymultiplexedvaxarrayimmunoassayforpneumococcalvaccineantigencharacterization
AT byrneemiliab 30minutehighlymultiplexedvaxarrayimmunoassayforpneumococcalvaccineantigencharacterization
AT kumarpardeep 30minutehighlymultiplexedvaxarrayimmunoassayforpneumococcalvaccineantigencharacterization
AT kimsookyung 30minutehighlymultiplexedvaxarrayimmunoassayforpneumococcalvaccineantigencharacterization
AT dawsonericad 30minutehighlymultiplexedvaxarrayimmunoassayforpneumococcalvaccineantigencharacterization