Approaches to assess new pneumococcal vaccines for immunogenicity, development and licensure

Pneumococcal conjugate vaccines (PCVs) have transformed the prevention of Streptococcus pneumoniae infections, yet challenges such as serotype replacement and vaccine escape demand their continual evaluation for improvement. This review outlines the core approaches used to assess pneumococcal vaccin...

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Main Authors: Feroze A. Ganaie, Moon H. Nahm
Format: Article
Language:English
Published: Taylor & Francis Group 2025-12-01
Series:Human Vaccines & Immunotherapeutics
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Online Access:https://www.tandfonline.com/doi/10.1080/21645515.2025.2545032
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author Feroze A. Ganaie
Moon H. Nahm
author_facet Feroze A. Ganaie
Moon H. Nahm
author_sort Feroze A. Ganaie
collection DOAJ
description Pneumococcal conjugate vaccines (PCVs) have transformed the prevention of Streptococcus pneumoniae infections, yet challenges such as serotype replacement and vaccine escape demand their continual evaluation for improvement. This review outlines the core approaches used to assess pneumococcal vaccine efficacy, from early-stage development to licensure. The WHO-ELISA is the established method for quantifying serotype-specific IgG levels, while the opsonophagocytic assay assess functional antibody activity and serve as an independent correlate of protection across both vaccine and cross-reactive serotypes. Assessment of antibody avidity and memory B-cell responses offer additional insights into immune quality and durability. Together, these methodologies form a robust framework for evaluating current and next-generation PCVs, supporting evidence-based vaccine licensure, informing public health strategies, and addressing evolving challenges in pneumococcal disease prevention.
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spelling doaj-art-7d1ec059af9c4c6f8be36a411a0ffa342025-08-20T03:03:04ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2025-12-0121110.1080/21645515.2025.2545032Approaches to assess new pneumococcal vaccines for immunogenicity, development and licensureFeroze A. Ganaie0Moon H. Nahm1Division of Pulmonary/Allergy/Critical Care, Department of Medicine, The University of Alabama at Birmingham, Birmingham, AL, USADivision of Pulmonary/Allergy/Critical Care, Department of Medicine, The University of Alabama at Birmingham, Birmingham, AL, USAPneumococcal conjugate vaccines (PCVs) have transformed the prevention of Streptococcus pneumoniae infections, yet challenges such as serotype replacement and vaccine escape demand their continual evaluation for improvement. This review outlines the core approaches used to assess pneumococcal vaccine efficacy, from early-stage development to licensure. The WHO-ELISA is the established method for quantifying serotype-specific IgG levels, while the opsonophagocytic assay assess functional antibody activity and serve as an independent correlate of protection across both vaccine and cross-reactive serotypes. Assessment of antibody avidity and memory B-cell responses offer additional insights into immune quality and durability. Together, these methodologies form a robust framework for evaluating current and next-generation PCVs, supporting evidence-based vaccine licensure, informing public health strategies, and addressing evolving challenges in pneumococcal disease prevention.https://www.tandfonline.com/doi/10.1080/21645515.2025.2545032Streptococcus pneumoniaeWHO-ELISAopsonophagocytic assaypneumococcal conjugate vaccinesimmune response
spellingShingle Feroze A. Ganaie
Moon H. Nahm
Approaches to assess new pneumococcal vaccines for immunogenicity, development and licensure
Human Vaccines & Immunotherapeutics
Streptococcus pneumoniae
WHO-ELISA
opsonophagocytic assay
pneumococcal conjugate vaccines
immune response
title Approaches to assess new pneumococcal vaccines for immunogenicity, development and licensure
title_full Approaches to assess new pneumococcal vaccines for immunogenicity, development and licensure
title_fullStr Approaches to assess new pneumococcal vaccines for immunogenicity, development and licensure
title_full_unstemmed Approaches to assess new pneumococcal vaccines for immunogenicity, development and licensure
title_short Approaches to assess new pneumococcal vaccines for immunogenicity, development and licensure
title_sort approaches to assess new pneumococcal vaccines for immunogenicity development and licensure
topic Streptococcus pneumoniae
WHO-ELISA
opsonophagocytic assay
pneumococcal conjugate vaccines
immune response
url https://www.tandfonline.com/doi/10.1080/21645515.2025.2545032
work_keys_str_mv AT ferozeaganaie approachestoassessnewpneumococcalvaccinesforimmunogenicitydevelopmentandlicensure
AT moonhnahm approachestoassessnewpneumococcalvaccinesforimmunogenicitydevelopmentandlicensure