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Dose finding for new vaccines: The role for immunostimulation/immunodynamic modelling.

Sophie J Rhodes¹, Gwenan M Knight¹, Denise E Kirschner²

¹TB Modelling Group, CMMID, TB Centre, London School of Hygiene and Tropical Medicine, UK.

Journal of Theoretical Biology

|January 15, 2019

Summary

Immunostimulation/immunodynamic (IS/ID) modeling applies quantitative methods to optimize vaccine dosing, reducing trial size and costs. This approach enhances vaccine development, potentially saving more lives by improving decision-making.

Keywords:

Immune response Mathematical modelling Vaccine development Vaccine dose optimization

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Area of Science:

Immunology
Pharmacometrics
Vaccinology

Background:

Current vaccine dose optimization relies on empirical methods, unlike drug development's quantitative approaches.
Quantitative methodologies in drug development accelerate decision-making and improve outcomes.
Applying these advanced methods to vaccines could significantly reduce clinical trial size, duration, and cost.

Discussion:

Immunostimulation/immunodynamic (IS/ID) modeling adapts pharmacokinetic/pharmacodynamic (PK/PD) principles for vaccine dose optimization.
IS/ID models mathematically describe immune response stimulation (IS) and dynamics (ID) post-vaccination.
This framework aims to accelerate vaccine dose decision-making, mirroring successes in drug development.

Key Insights:

IS/ID modeling offers a quantitative alternative to empirical vaccine dosing strategies.
Translating PK/PD modeling to IS/ID can enhance efficiency and reduce resource intensity in vaccine trials.
Successful implementation requires generating and collating vaccine-specific allometry and dose-response data.

Outlook:

Further development of IS/ID modeling necessitates generating robust datasets on vaccine allometry and dose-dependent dynamics.
A collaborative ecosystem involving academia, industry, regulators, and public health agencies is crucial for sharing expertise and data.
This interdisciplinary approach will accelerate the adoption of quantitative methods in vaccine development, ultimately improving public health outcomes.