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The Correlated Beta Dose Optimisation Approach: Optimal Vaccine Dosing Using Mathematical Modelling and Adaptive
John Benest1, Sophie Rhodes1, Thomas G Evans2
1Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK.
Vaccines
|November 11, 2022
Summary
A new Correlated Beta (CoBe) dose optimization approach effectively identifies optimal vaccine doses. This method balances efficacy and toxicity, improving vaccine development and public health outcomes.
Area of Science:
- Biostatistics
- Pharmacometrics
- Vaccinology
Background:
- Optimizing vaccine dosage is crucial for maximizing efficacy and minimizing toxicity.
- Current mathematical modeling and adaptive trial designs for dose optimization are underutilized due to model selection uncertainty.
- Non-parametric models offer a promising alternative for dose-response modeling.
Purpose of the Study:
- To introduce and evaluate a novel non-parametric approach, the Correlated Beta (CoBe) dose optimization method, for determining optimal vaccine doses.
- To compare the performance of the CoBe approach against existing methods using simulation studies.
- To assess the ability of the CoBe approach to balance vaccine efficacy and toxicity while incorporating expert knowledge.
Main Methods:
- Development of the non-parametric Continuous Correlated Beta Process model for dose-efficacy and dose-toxicity relationships.
- Implementation of an adaptive trial design framework for dose optimization.
- Simulation studies to evaluate the CoBe approach against other dose optimization strategies for single and prime/boost vaccine regimens.
Main Results:
- The CoBe approach effectively located the maximum efficacy dose for both single and prime/boost vaccine administrations.
- The method successfully identified doses that maximized efficacy while minimizing vaccine-related toxicity.
- The CoBe approach demonstrated flexibility in incorporating expert knowledge, a challenge for previous parametric models.
Conclusions:
- The Correlated Beta (CoBe) dose optimization approach, combining non-parametric modeling and adaptive trial design, is a powerful tool for optimizing vaccine dosage.
- This novel method offers a robust strategy for balancing vaccine efficacy and safety.
- Mathematical modeling and adaptive trial designs are essential for advancing vaccine development, maximizing public health benefits, and reducing disease burden.
Keywords:
adaptive designclinical trialscontinual modellingdose responsedosingmodellingnon-parametric modelsMore Related Videos
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