Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2025 Dec;21(1):2545032.
doi: 10.1080/21645515.2025.2545032. Epub 2025 Aug 13.

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

Feroze A Ganaie  1 , Moon H Nahm  1
Affiliations
Review

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

Feroze A Ganaie et al. Hum Vaccin Immunother. 2025 Dec.

Abstract

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.

Keywords: Streptococcus pneumoniae; WHO-ELISA; immune response; opsonophagocytic assay; pneumococcal conjugate vaccines.

PubMed Disclaimer

Conflict of interest statement

UAB has Intellectual Property Rights to several reagents, including monoclonal antibodies and MOPA target strains developed in M.H.N.’s laboratory. The authors (F.A.G and M.H.N.) are UAB employees. M.H.N is a founder of SunFire Biotechnologies.

References

    1. Song JY, Nahm MH, Moseley MA.. Clinical implications of pneumococcal serotypes: invasive disease potential, clinical presentations, and antibiotic resistance. J Korean Med Sci. 2013;28(1):4–10. doi: 10.3346/jkms.2013.28.1.4. - DOI - PMC - PubMed
    1. Wahl B, O’Brien KL, Greenbaum A, Majumder A, Liu L, Chu Y, Lukšić I, Nair H, McAllister DA, Campbell H, et al. Burden of Streptococcus pneumoniae and Haemophilus influenzae type b disease in children in the era of conjugate vaccines: global, regional, and national estimates for 2000-15. Lancet Glob Health. 2018;6(7):e744–57. doi: 10.1016/S2214-109X(18)30247-X. - DOI - PMC - PubMed
    1. Drijkoningen JJC, Rohde GGU. Pneumococcal infection in adults: burden of disease. Clin Microbiol Infect. 2014;20:45–51. - PubMed
    1. Pasteur L. Note sur la maladie nouvelle provoquée par la salive d’un enfant mort de la rage. Bull Acad Méd (Paris). 1881;10(1):94–103. doi: 10.3406/rmv.1881.2052. - DOI
    1. Sternberg GM. A fatal form of septicaemia in the rabbit produced by the subcutaneous injection of human saliva: an experimental research. Baltimore: John Murphy & Co; 1881.

MeSH terms

LinkOut - more resources