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    Integrated Specific Pathogen Free Research Models and Human New Approach Methodologies to Advance HIV AIDS Research (U42 Clinical Trial Not Allowed)

    This grant funds development and integration of human-based research methods and supports high-quality animal models to advance HIV/AIDS research while reducing animal use where possible.

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    Funder: National Institutes of Health

    Due Dates (Anticipated): January 2027 (full application deadline, projected)

    Funding Amounts: Award ceiling: $2,725,311 | Award floor: $212,004 | ~4 awards expected

    Summary: Supports development and integration of human new approach methodologies (NAMs) and maintenance of specific pathogen free (SPF) research models to advance HIV/AIDS research.


    Description

    This funding opportunity is designed to accelerate the adoption, validation, and integration of human new approach methodologies (NAMs) in NIH-funded HIV/AIDS research, while also supporting high-quality specific pathogen free (SPF) animal model resources where in vivo models remain necessary. The initiative has two main priorities:

    • NAMs-Enabled Component:

      • Implement a stewardship framework to identify and support studies where NAMs can reduce or replace SPF in vivo model use, without compromising scientific rigor or translational relevance.
      • Integrate a NAMs triage and consultation service into intake workflows, document reductions/replacements, and establish referral pathways to NAM centers and human tissue resources.
      • Optional: Provide HIV-relevant human in vitro testing support, develop SOPs, quality control frameworks, and pilot benchmarking projects for human NAMs.
    • SPF Resource Component:

      • Maintain core SPF colony operations, including colony management, transparent request allocation, virologic surveillance, and rapid mitigation to preserve SPF status.
      • Support high-resolution immunogenetic characterization (e.g., MHC typing) to enable rigorous, genotype-informed studies and efficient stewardship of limited in vivo resources.

    The program aims to foster the responsible transition toward human-relevant research methods while ensuring rigorous support for studies that require well-characterized animal models.


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