Literature DB >> 32686954

Optimization and validation of a microcolony multiplexed opsonophagocytic killing assay for 15 pneumococcal serotypes.

Katrina M Nolan1, Marie E Bonhomme1, Christina J Schier1, Tina Green1, Joseph M Antonello1, Rocio D Murphy1.   

Abstract

Background: To streamline and improve throughput, the agar-based multiplexed opsonophagocytic killing assay (MOPA) was optimized and validated on a microcolony platform for use in the Phase III clinical trial program for V114, an MSD 15-valent pneumococcal conjugate vaccine candidate. Results & methodology: The precision, dilutional linearity and specificity of the microcolony MOPA (mMOPA) were assessed for each serotype in validation experiments. All prespecified acceptance criteria on assay performance were satisfied. Accuracy was assessed by testing 007sp and the US FDA reference panel and comparing to consensus values. The mMOPA produced comparable results to other opsonophagocytic killing assays/MOPAs.
Conclusion: The mMOPA is suitable for measuring functional antibodies in adult and pediatric samples. Benefits include throughput, reduced analyst-to-analyst variability and automation potential.

Entities:  

Keywords:  FDA reference panel; MOPA; OPA; microcolony; multiplexed opsonophagocytic killing assay; optimization; pneumococcal vaccine; validation

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Year:  2020        PMID： 32686954     DOI： 10.4155/bio-2020-0024

Source DB:  PubMed          Journal:  Bioanalysis        ISSN： 1757-6180            Impact factor:   2.681


  4 in total

1.  Novel Pneumococcal Protein-Polysaccharide Conjugate Vaccine Based on Biotin-Streptavidin.

Authors:  Mengze Guo; Xiaonan Guo; Chenxing Zhang; Shidong Zhu; Yue Zhang; Tiejun Gu; Wei Kong; Yongge Wu
Journal:  Infect Immun       Date:  2021-10-25       Impact factor: 3.609

2.  Safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in adults living with HIV.

Authors:  Lerato Mohapi; Yvett Pinedo; Olayemi Osiyemi; Khuanchai Supparatpinyo; Winai Ratanasuwan; Jean-Michel Molina; Ron Dagan; Gretchen Tamms; Tina Sterling; Ying Zhang; Alison Pedley; Jon Hartzel; Yanqing Kan; Kim Hurtado; Luwy Musey; Jakub K Simon; Ulrike K Buchwald
Journal:  AIDS       Date:  2022-03-01       Impact factor: 4.177

3.  Immunogenicity, Safety, and Tolerability of V114, a 15-Valent Pneumococcal Conjugate Vaccine, in Immunocompetent Adults Aged 18-49 Years With or Without Risk Factors for Pneumococcal Disease: A Randomized Phase 3 Trial (PNEU-DAY).

Authors:  Laura L Hammitt; Dean Quinn; Ewa Janczewska; Francisco J Pasquel; Richard Tytus; K Rajender Reddy; Katia Abarca; Ilsiyar M Khaertynova; Ron Dagan; Jennifer McCauley; Kyeongmi Cheon; Alison Pedley; Tina Sterling; Gretchen Tamms; Luwy Musey; Ulrike K Buchwald
Journal:  Open Forum Infect Dis       Date:  2021-12-18       Impact factor: 3.835

4.  Safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, administered concomitantly with influenza vaccine in healthy adults aged ≥50 years: a randomized phase 3 trial (PNEU-FLU).

Authors:  Randall Severance; Howard Schwartz; Ron Dagan; Laurie Connor; Jianing Li; Alison Pedley; Jonathan Hartzel; Tina M Sterling; Katrina M Nolan; Gretchen M Tamms; Luwy K Musey; Ulrike K Buchwald
Journal:  Hum Vaccin Immunother       Date:  2021-11-02       Impact factor: 3.452
  4 in total

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