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....
Saved in:
| Main Authors: | , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2025-01-01
|
| Series: | CPT: Pharmacometrics & Systems Pharmacology |
| Online Access: | https://doi.org/10.1002/psp4.13237 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1841555889626021888 |
|---|---|
| author | Vijay Ivaturi Husain Attarwala Weiping Deng Baoyu Ding Sabine Schnyder Ghamloush Bethany Girard Javid Iqbal Saugandhika Minnikanti Honghong Zhou Jacqueline Miller Rituparna Das |
| author_facet | Vijay Ivaturi Husain Attarwala Weiping Deng Baoyu Ding Sabine Schnyder Ghamloush Bethany Girard Javid Iqbal Saugandhika Minnikanti Honghong Zhou Jacqueline Miller Rituparna Das |
| author_sort | Vijay Ivaturi |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-3efbfb909e4c4c1bba86f0f8ffbfe51f |
| institution | Kabale University |
| issn | 2163-8306 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | CPT: Pharmacometrics & Systems Pharmacology |
| spelling | doaj-art-3efbfb909e4c4c1bba86f0f8ffbfe51f2025-01-07T20:48:59ZengWileyCPT: Pharmacometrics & Systems Pharmacology2163-83062025-01-01141425110.1002/psp4.13237Immunostimulatory/Immunodynamic model of mRNA‐1273 to guide pediatric vaccine dose selectionVijay Ivaturi0Husain Attarwala1Weiping Deng2Baoyu Ding3Sabine Schnyder Ghamloush4Bethany Girard5Javid Iqbal6Saugandhika Minnikanti7Honghong Zhou8Jacqueline Miller9Rituparna Das10Pumas‐AI, Inc Dover Delaware USAModerna, Inc. Cambridge Massachusetts USAModerna, Inc. Cambridge Massachusetts USAModerna, Inc. Cambridge Massachusetts USAModerna, Inc. Cambridge Massachusetts USAModerna, Inc. Cambridge Massachusetts USAModerna, Inc. Cambridge Massachusetts USAPumas‐AI, Inc Dover Delaware USAModerna, Inc. Cambridge Massachusetts USAModerna, Inc. Cambridge Massachusetts USAModerna, Inc. Cambridge Massachusetts USAAbstract 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.https://doi.org/10.1002/psp4.13237 |
| spellingShingle | Vijay Ivaturi Husain Attarwala Weiping Deng Baoyu Ding Sabine Schnyder Ghamloush Bethany Girard Javid Iqbal Saugandhika Minnikanti Honghong Zhou Jacqueline Miller Rituparna Das Immunostimulatory/Immunodynamic model of mRNA‐1273 to guide pediatric vaccine dose selection CPT: Pharmacometrics & Systems Pharmacology |
| title | Immunostimulatory/Immunodynamic model of mRNA‐1273 to guide pediatric vaccine dose selection |
| title_full | Immunostimulatory/Immunodynamic model of mRNA‐1273 to guide pediatric vaccine dose selection |
| title_fullStr | Immunostimulatory/Immunodynamic model of mRNA‐1273 to guide pediatric vaccine dose selection |
| title_full_unstemmed | Immunostimulatory/Immunodynamic model of mRNA‐1273 to guide pediatric vaccine dose selection |
| title_short | Immunostimulatory/Immunodynamic model of mRNA‐1273 to guide pediatric vaccine dose selection |
| title_sort | immunostimulatory immunodynamic model of mrna 1273 to guide pediatric vaccine dose selection |
| url | https://doi.org/10.1002/psp4.13237 |
| work_keys_str_mv | AT vijayivaturi immunostimulatoryimmunodynamicmodelofmrna1273toguidepediatricvaccinedoseselection AT husainattarwala immunostimulatoryimmunodynamicmodelofmrna1273toguidepediatricvaccinedoseselection AT weipingdeng immunostimulatoryimmunodynamicmodelofmrna1273toguidepediatricvaccinedoseselection AT baoyuding immunostimulatoryimmunodynamicmodelofmrna1273toguidepediatricvaccinedoseselection AT sabineschnyderghamloush immunostimulatoryimmunodynamicmodelofmrna1273toguidepediatricvaccinedoseselection AT bethanygirard immunostimulatoryimmunodynamicmodelofmrna1273toguidepediatricvaccinedoseselection AT javidiqbal immunostimulatoryimmunodynamicmodelofmrna1273toguidepediatricvaccinedoseselection AT saugandhikaminnikanti immunostimulatoryimmunodynamicmodelofmrna1273toguidepediatricvaccinedoseselection AT honghongzhou immunostimulatoryimmunodynamicmodelofmrna1273toguidepediatricvaccinedoseselection AT jacquelinemiller immunostimulatoryimmunodynamicmodelofmrna1273toguidepediatricvaccinedoseselection AT rituparnadas immunostimulatoryimmunodynamicmodelofmrna1273toguidepediatricvaccinedoseselection |