Statistics for
Vaccine Development
Quantics can support you through the complete vaccine development pathway
Correlates of Protection Experience
Quantics has been involved with the development, optimization and validation of a wide range of vaccine related bioassays for a number of UK, US and European customers. We have particular experience in supporting Correlation of Protection and Passive Transfer analysis for complex biodefence vaccine programs including:
Anthrax
Ricin
Bubonic Plague
Marburg
Botulinum
Ebola
Survival Analysis for Vaccine Studies
Quantics’ biomathematical experience can maximize the information obtained from expensive laboratory work. Quantics is a keen supporter of “3R” principles and our biomathematical expertise can significantly reduce the animals, replicates, and experiments required.
Many in vivo vaccine assays rely on binary data – is the subject dead or alive at a certain timepoint? Analyses which use continuous time-to-event data, such as survival analyses, are mathematically more efficient leading to improved performance. This means fewer subjects are required to achieve acceptable precision. By utilising time-to-event data instead of traditional methods, animal requirements can be reduced by >40% in some instances.
Project Insight
A number of our clients have taken survival analysis for their studies.
Client A: This client reduced the number of animals from 16 to 12 per group and improved the precision of the RP estimate.
Client B: This client was able to improve the precision of the RP estimate by a factor of approximately 2.
Client C: This client was able to improve the pass rate for their FDA-required test of parallelism (similarity) of the test samples versus the reference standard. With a probit model the failure rate was 25%; with the survival model parallelism failures were reduced to 5%.
Natural History Studies
Quantics is experienced at supporting Natural History Studies as part of a vaccine development programme. The natural behaviour of a target pathogen – including its pathology, immunology, and epidemiology – has a strong influence on the path taken during the development and testing of a new vaccine. Whether its designing studies or providing advice on endpoint selection or sample sizes, Quantics will help optimise the performance of your study.
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