The Bill and Melinda Gates Foundation (BMGF) has established and funded a Systems Biology/Systems Immunology Consortium to discover and validate molecular, immunological, and clinical signatures of vaccine efficacy for infectious diseases.
Due to limited capacity and resources, not all study requests with available or planned samples can be analyzed by the Consortium. Requests for the following types of studies will be considered:
• Phase IIB/III efficacy studies, human challenge studies, and studies with primary clinical endpoints from which correlates of vaccine-induced protection from infection or disease could be derived
• Natural history (human) studies from which correlates of risk for disease or infection (or ‘natural/innate’ protection, if populations can be found) could be derived
• Treatment monitoring studies from which correlates of treatment success or failure could be derived
• Preclinical studies critical for informing future efficacy study design or from which candidate correlates of protection or risk can be derived
• Early phase clinical studies in endemic populations that can inform later-stage trial design, via a kinetic analysis, and/or from which correlates of immunogenicity and reactogenicity can be derived
• Other minimal criteria include adequate study power and design, appropriate and sufficient samples, adequate sample quality, and appropriate analysis request.
• Study requests should contribute to the existing BMGF strategies and be confirmed as a priority for a PST/Function
• Studies meeting the above criteria with the sample availability and study design to utilize both Systems Immunology and Systems Biology platforms are of particular interest, and should be mentioned explicitly in your request.
Approved study requests become “Candidate Studies.” All Candidate Studies will then be prioritized with the help of a Systems Biology/Systems Immunology Scientific Advisory Board, which will convene regularly, with the BMGF and the Consortium, to consider Candidate Studies. If a Candidate Study is approved for analysis by the SAB, Consortium and BMGF, the study stakeholders will collaborate with the Consortium to draft an analytical plan, which will include the objectives of the study, samples sets to be analyzed, reagents to be developed, assays and computational approaches to be employed, and data storage and dissemination. Once an analytical plan is approved by the Advisory Board, the analyses, funded by BMGF, would begin.
Immune monitoring services
We have standardized immunoassays for human cytokines, which can be used to assay serum, plasma, cell culture supernatants, tissue homogenates, or other fluids. We measure multiple cytokines simultaneously using either Luminex (up to 63 analytes) or MesoScale Discovery (MSD, up to 10 analytes) systems. We also provide assays for other soluble proteins on the MSD platform.
Mass cytometry, or CyTOF (DVS Sciences), is a variation of flow cytometry in which antibodies are labeled with heavy metal ion tags rather than fluorochromes. Readout is by time-of-flight mass spectrometry. This allows for the combination of many more antibody specificities in a single samples, without significant spillover between channels. We have standardized an immunophenotyping CyTOF panel with 30 antibodies; an intracellular cytokine+phenotyping panel with 38 antibodies; and a phospho-specific epitope+phenotyping panel with 30 antibodies. A tetramer-based panel for following specific T cell populations is also available.
Flow cytometry is used to assess immune cell phenotypes and functions. We offer standardized immunophenotyping, phosphoepitope, and intracellular cytokine assays for human blood cells. Our assays have all been optimized for use with cryopreserved PBMC.
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