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November 02, 2023 article Open access Aachen paper

A Quantitative Clinical Pharmacology-Based Framework For Model-Informed Vaccine Development

Journal of Pharmaceutical Sciences, vol. 113, pp. 22–32

DOI: 10.1016/j.xphs.2023.10.043 Full text (OA) OpenAlex

Abstract

Historically, vaccine development and dose optimization have followed mostly empirical approaches without clinical pharmacology and model-informed approaches playing a major role, in contrast to conventional drug development. This is attributed to the complex cascade of immunobiological mechanisms associated with vaccines and a lack of quantitative frameworks for extracting dose-exposure-efficacy-toxicity relationships. However, the Covid-19 pandemic highlighted the lack of sufficient immunogenicity due to suboptimal vaccine dosing regimens and the need for well-designed, model-informed clinical trials which enhance the probability of selection of optimal vaccine dosing regimens. In this perspective, we attempt to develop a quantitative clinical pharmacology-based approach that integrates vaccine dose-efficacy-toxicity across various stages of vaccine development into a unified framework that we term as model-informed vaccine dose-optimization and development (MIVD). We highlight scenarios where the adoption of MIVD approaches may have a strategic advantage compared to conventional practices for vaccines.

Authors 4

  1. Rajat Desikan corresponding

    GlaxoSmithKline (United Kingdom)

    Affiliation as printed

    Clinical Pharmacology Modelling & Simulation, GSK, United Kingdom. Electronic address: rajat.x.desikan@gsk.com

    Clinical Pharmacology Modelling & Simulation, GSK, United Kingdom

  2. Massimiliano Germani
    Affiliation as printed

    Clinical Pharmacology Modelling & Simulation, GSK, Belgium

  3. Piet H. van der Graaf Aachen Leiden Academic Centre for Drug Research

    Leiden University

    Affiliation as printed

    Certara QSP, Canterbury Innovation Centre, University Road, Canterbury CT2 7FG, United Kingdom; Leiden Academic Centre for Drug Research, Einsteinweg 55, 2333 CC Leiden, Netherlands

    Certara QSP, Canterbury Innovation Centre, University Road, Canterbury CT2 7FG, United Kingdom

    Leiden Academic Centre for Drug Research, Einsteinweg 55, 2333 CC Leiden, Netherlands

  4. Mindy He Magee
    Affiliation as printed

    Clinical Pharmacology Modelling & Simulation, GSK, United States

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References 76