Immunostimulatory/Immunodynamic model of mRNA‐1273 to guide pediatric vaccine dose selection
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....
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| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2025-01-01
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| Series: | CPT: Pharmacometrics & Systems Pharmacology |
| Online Access: | https://doi.org/10.1002/psp4.13237 |
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| Summary: | 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. |
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| ISSN: | 2163-8306 |