Non Human Primate study data management to correlate with human studiesSITUATION

  • Emerging vaccine developer currently conducting one human study as well as an non human primate study on an investigational vaccine against a solid tumor cancer indication
  • Goals of study: a) Utilize the NHP model to inform the clinical dosing regimen and dosing intervals to maximize the immune response over a short period of time b) acquire key data to support a comparison to human trail
  • Datasets: ELISpot, Serum Cytokones, Serum Chemistry, Liver Function, Acute Phase reactants, CBC, ICS (flow cytometry) , single cell RNASeq/TCRSeq


  • What is the maximum tolerated dose in NHP model that can predict a similar response in human
  • What similarities or differences are there in immune response to vaccine between NHP and human data? Eg. Chemical and cytokine signatures between NHP and human?
  • What is the functional profile of the activating T-Cell? Many such questions to be reviewed with integrated data


  • In the process of setting up the user requirements to integrate multiple sources of data
  • Evaluated several vendors that can integrate biomarker data and selected one leading vendor; developing a pilot solution


  • Project at early stages of evaluation

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