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Validation of A Triple-color Pseudovirion-based Neutralization Assay for Immunogenicity Assessment of A 14-valent Recombinant Human Papillomavirus Vaccine
  • +5
  • Liangzhi Xie,
  • Shuman Gao,
  • Caixia Feng,
  • Yajuan Kou,
  • Dandan Zhao,
  • Chunxia Luo,
  • Xuefeng Li,
  • Yang Wang
Liangzhi Xie
Beijing Engineering Research Center of Protein and Antibody

Corresponding Author:lx@sinocelltech.com

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Shuman Gao
Beijing Engineering Research Center of Protein and Antibody
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Caixia Feng
Beijing Engineering Research Center of Protein and Antibody
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Yajuan Kou
Beijing Engineering Research Center of Protein and Antibody
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Dandan Zhao
Beijing Engineering Research Center of Protein and Antibody
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Chunxia Luo
Beijing Engineering Research Center of Protein and Antibody
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Xuefeng Li
Beijing Engineering Research Center of Protein and Antibody
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Yang Wang
Beijing Engineering Research Center of Protein and Antibody
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Abstract

The validation of a bioanalytical method is essential to ascertain its suitability for a specific purpose and ensure the accuracy of its analytical outcomes, particularly within the pharmaceutical industry. The pseudovirion-based neutralization assay (PBNA) is considered the gold standard for detecting and quantifying neutralizing antibodies against human papillomavirus in the development of the disease-prevent vaccines. This paper introduces a modified high-throughput triple-color PBNA method designed to simultaneously detect the neutralizing antibodies against as many as 14 HPV types. The primary objective is to present a comprehensive validation of the triple-color PBNA method applicable to general vaccine immunogenicity assays. The results demonstrate good specificity, accuracy, precision, linearity, robustness, and applicability of the method. This innovative triple-color PBNA provides a high-throughput approach for large-scale immunogenicity assessments that vaccine developers might encounter, overcoming limitations of labor-intensive and complex nature associated with traditional neutralization assays. The research establishes a robust foundation and good guiding example for evaluating vaccine responses in both preclinical and clinical phases, offering valuable insights to the field.
Submitted to Journal of Medical Virology
31 May 20241st Revision Received
31 May 2024Submission Checks Completed
31 May 2024Assigned to Editor
31 May 2024Review(s) Completed, Editorial Evaluation Pending
17 Jul 2024Editorial Decision: Revise Minor
18 Jul 20242nd Revision Received
22 Jul 2024Submission Checks Completed
22 Jul 2024Assigned to Editor
22 Jul 2024Review(s) Completed, Editorial Evaluation Pending
23 Jul 2024Reviewer(s) Assigned
05 Aug 2024Editorial Decision: Accept