The vaccine IS/ID consortium aim to compliment the existing dose-finding methods used in vaccine development with mathematical frameworks translated from drug development.
The vaccine IS/ID modelling consortium are vaccine developers, drug developers, mathematical modellers and regulators interested in using mathematical modelling methods to improve decisions around vaccine dose development.
Vaccine dosing decision making employs relatively antiquated methods compared to the methods employed for drug dosing decision making. The vaccine IS/ID consortium aim to compliment the existing dose-finding methods used in vaccine development with mathematical frameworks translated from drug development. As such, we propose the new field of vaccine immunostimulation/immunodynamic modelling.
Our aims
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Quantification of vaccine dose response curves
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Utilization of optimal design methods to design vaccine trials with the least possible resources
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Translation of dose response curves across species
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Vaccination regimen design
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Vaccine trial simulation
Richard
White
Prof of Infectious Disease Modelling
Thomas Evans
CEO / VACCITECH
Steve Kern
Deputy Director, Quantitative Sciences / BMGF
IS/ID modelling is currently being implemented in the following areas
- Tuberculosis
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First steps to include IS/ID modelling into vaccine development are under way in TB research.
We designed and conducted an intensive animal vaccine multi-dose study of a candidate TB vaccine (presently in phase 2) specifically to generate data to translate dose response curves to humans.
The predicted best TB vaccine dose is likely to be lower than previously investigated
(data published here)
A T cell mathematical model predicts dose-dependent difference in mouse immune response following vaccination
(Data presented at the 2017 Union World Conference on Lung Health. Abstract no. SOA-328-12, pg. S85)
- Adenovirus
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Vaccitech and the ISID consortium have undertaken a study to understand the nature of the dose-related T cell responses following a single dose of replication incompetent adenoviral vaccines. A systematic review that is registered in Prospero is underway, and the extracted data will then be analysed to try an generate the most likely response dose profile. We will apply this data to an adaptive design of the next Vaccitech product to enter Phase 1 human trials, in order to arrive at the best decision on dose selection, with knowledge of the confidence interval surrounding that decision.
We would like to encourage a discussion on the use of IS/ID modelling to improve vaccine dose finding. We welcome any questions or comments. Please send your comment by clicking on the button below.