1. Immunostimulatory/Immunodynamic model of mRNA-1273 to guide pediatric vaccine dose selection.
- Author
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Ivaturi V, Attarwala H, Deng W, Ding B, Schnyder Ghamloush S, Girard B, Iqbal J, Minnikanti S, Zhou H, Miller J, and Das R
- Abstract
COVID-19 vaccines, including mRNA-1273, have been rapidly developed and deployed. Establishing the optimal dose is crucial for developing a safe and effective vaccine. Modeling and simulation have the potential to play a key role in guiding the selection and development of the vaccine dose. In this context, we have developed an immunostimulatory/immunodynamic (IS/ID) model to quantitatively characterize the neutralizing antibody titers elicited by mRNA-1273 obtained from three clinical studies. The developed model was used to predict the optimal vaccine dose for future pediatric trials. A 25-μg primary vaccine series was predicted to meet non-inferiority criteria in young children (aged 2-5 years) and infants (aged 6-23 months). The geometric mean titers and geometric mean ratios for this dose level predicted using the IS/ID model a priori matched those observed in the pediatric clinical study. These findings demonstrate that IS/ID models represent a novel approach to guide data-driven clinical dose selection of vaccines., (© 2024 The Author(s). CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.) more...
- Published
- 2024
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