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Updated: Jun 3, 2025

Experimental Human Pneumococcal Carriage

Experimental Human Pneumococcal Carriage

Published on: February 15, 2013

Establishing a new human pneumococcal standard reference serum, MPRSS-01.

Joseph M Antonello¹, Rocio D Murphy¹, Chitrananda Abeygunawardana¹

¹Merck & Co., Inc., Rahway, New Jersey, USA.

|January 8, 2025

Summary

A new reference serum standard, MPRSS-01, was developed for measuring pneumococcal vaccine immunogenicity, including novel serotypes beyond the existing 007sp standard. This ensures accurate antibody measurements for next-generation pneumococcal conjugate vaccines (PCVs).

Keywords:

007sp MPRSS-01 pneumococcal standard reference pneumococcal vaccine standardization

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Last Updated: Jun 3, 2025

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Area of Science:

Immunology and Vaccinology
Clinical Chemistry and Diagnostics

Background:

Pneumococcal vaccine immunogenicity is assessed by measuring serotype-specific immunoglobulin G (IgG) antibody levels using the 007sp reference serum standard.
The development of new pneumococcal conjugate vaccines (PCVs) with expanded serotype coverage necessitates a new reference serum standard.

Purpose of the Study:

To establish a new pneumococcal reference serum standard (MPRSS-01) encompassing 33 serotypes, including novel ones not present in the existing 007sp standard.
To ensure continuity and accuracy in measuring the immunogenicity of next-generation PCVs like V116.

Main Methods:

Antibody concentrations for 33 pneumococcal serotypes were assigned in MPRSS-01 using the pneumococcal electrochemiluminescence assay.
Direct calibration to 007sp was used for 24 established serotypes; cross-standardization with serotype 7F as a calibrator was employed for nine novel serotypes.
Potential biases in cross-standardization were identified and addressed through adjustments, ensuring accurate IgG concentration assignments for novel serotypes.

Main Results:

MPRSS-01 successfully assigned antibody concentrations for 33 pneumococcal serotypes, including nine novel ones.
A robust method was established to link MPRSS-01 to the historical 007sp standard, enabling consistent immunogenicity assessments.
The proposed methodology and assignments were accepted by the Center for Biologics Evaluation and Research (CBER).

Conclusions:

The development of MPRSS-01 provides a crucial standard for evaluating the immunogenicity of advanced pneumococcal vaccines.
This new standard bridges historical and contemporary pneumococcal reference sera, supporting the licensure of vaccines like V116.
Accurate antibody concentration assignments are vital for ensuring the efficacy and safety of pneumococcal vaccines.