Development and Validation of Enzyme-Linked Immunosorbent Assay for Group B Streptococcal Polysaccharide Vaccine

Streptococcus agalactiae (group B Streptococcus, GBS) is a leading cause of neonatal sepsis and meningitis in infants. Limitations of prenatal GBS screening and intrapartum antibiotic prophylaxis render developing GBS vaccines a high priority. In this study, we developed an enzyme-linked immunosorbe...

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Veröffentlicht in:Vaccines (Basel) 2021-05, Vol.9 (6), p.545, Article 545
Hauptverfasser: Jang, A-Yeung, Choi, Min-Joo, Zhi, Yong, Ji, Hyun-Jung, Noh, Ji-Yun, Yoon, Jin-Gu, Cheong, Hee-Jin, Kim, Woo-Joo, Seo, Ho-Seong, Song, Joon-Young
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Sprache:eng
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Zusammenfassung:Streptococcus agalactiae (group B Streptococcus, GBS) is a leading cause of neonatal sepsis and meningitis in infants. Limitations of prenatal GBS screening and intrapartum antibiotic prophylaxis render developing GBS vaccines a high priority. In this study, we developed an enzyme-linked immunosorbent assay (ELISA) for the practical and large-scale evaluation of GBS capsular polysaccharide (PS) vaccine immunogenicity against three main serotypes, Ia, III, and V. GBS-ELISA was developed and subsequently validated using a standardized curve-fitting four-parameter logistic method. Specificity was measured using adsorption of serum with homologous and heterologous PS. Homologous adsorption showed a >= 75% inhibition of all three serotypes, whereas with heterologous PS, IgG GBS-ELISA inhibited only 50%, even after adsorption with heterologous PS (III or V). In comparison, the inhibition opsonophagocytic killing assay (OPA) of serotypes Ia GBS exhibited a reduction in opsonophagocytic activity of only 20% and 1.1% for serotypes III and V GBS, respectively. The precision of the GBS-ELISA was assessed in five independent experiments using four serum samples. The coefficient of variation was
ISSN:2076-393X
2076-393X
DOI:10.3390/vaccines9060545