In case you missed PharmSci360 last year, we are excited to highlight a few impactful posters from the conference in a few discussion posts. There is always really great science presented in the posters at AAPS conferences and we want to make sure that it is shared with the community!
The poster titled "Development and Fit-for-Purpose(FFP) Validation of a 35-Color Ex Vivo Stimulation and Activation-Induced Marker (AIM) Assay to Assess Vaccine-Induced Immune Responses in Human Vaccine Trials" was presented at PharmSci360 in Salt Lake City by @Md Mahmudul Hasan and colleagues. Summary and highlights of the poster include:
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Activation of the T cell compartment plays a critical role in long lasting protection by inducing immune memory.
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Activation-induced marker (AIM) assays are a suitable option to assess cell-mediated immune responses when cell numbers are limited, especially in pediatric subjects.
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To address exploratory endpoints in the clinical study, Moderna Global Clinical Biomarker Lab developed and validated a fit-for-purpose 35-color AIM assay to monitor antigen specific T-cell populations along with immunophenotyping of other lymphoid and myeloid populations.
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Validation method was conducted following CLSI H-62 guidelines which includes Assay Precision assessments of Repeatability (Intra-Assay) and Reproducibility (Inter-Instrument, Inter-Analyst, Inter-Run), and post-staining sample stability.
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An acceptance criterion of ≤ 25% CV was applied for intra-assay, inter-assay, inter-analyst, and inter-instrument precision.
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Stability was established at the latest time point where a ≤ 25% change from the baseline was observed.
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This assay will be used to assess cell mediated immune responses induced by Moderna trail vaccines.
- Supernatant collected in this assay was also evaluated and presented in a poster at PharmSci360 as well
- Poster titled "Title: Multiplexed Cytokine Measurements in Culture Supernatants upon Ex Vivo Stimulation of Human PBMCs to Assess Cellular Immune Response in Vaccine Studies"
Both posters are attached. The author is happy to answer any questions. Simply reply to this post!
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Amanda Hays Ph.D.
Scientific Officer
BioAgilytix
Overland Park KS
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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