Strategies for Controlled Release of HIV Vaccines (SCORE-H) (R01 Clinical Trial Not Allowed)

Background
The purpose of this Notice of Funding Opportunity (NOFO) is to support product-focused research to advance controlled release vaccine strategies to improve immune responses for HIV prevention, treatment, and cure and develop simplified or single-shot vaccination formulations. Recent advances in materials-based science, controlled release technologies, delivery systems, and immunology provide opportunities to enhance the quality, potency and durability of vaccine-induced T cell and antibody responses to HIV-1.

Grant Details
The purpose of this grant is to support research to advance controlled-release strategies for HIV vaccines that aim to elicit protective and durable broadly neutralizing responses and antiviral T-cell/innate responses. Proposed projects may be early or later in product development. Depending on the stage of product development, applications should propose strategies to establish proof-of-principle, optimize approaches in small animal models, show maintenance of vaccine structure and bioactivity throughout the delivery period, evaluate feasibility for GMP manufacturing, and study the safety of the optimized delivery strategy.

Proof-of-principle studies should include an assessment of immunogenicity and preliminary efficacy in a relevant animal model against a robust benchmark. Projects will necessitate collaborative cross-disciplinary teams, including experts in immunology, product development and behavioral scientists, as applicable. Applications must include significant involvement of a translational partner with product development expertise to address the considerable manufacturing challenges.

Eligibility Requirements
Eligible applicants include higher education institutions, nonprofits with 501(c)(3) IRS status, for-profit organizations, state governments, county governments, city or township governments, special district governments, Indian/Native American tribal governments (federally recognized), independent school districts, public housing authorities/Indian housing authorities, Native American tribal organizations (other than federally recognized tribal governments), faith-based or community-based organizations, regional organizations, non-domestic (non-U.S.) entities (foreign organizations), foreign components of U.S. Organizations.

Period of Performance
The period of performance for the grant is up to 5 years.

Grant Value
The National Institute of Allergy and Infectious Diseases (NIAID) intends to commit $3,000,000 and the National Institute of Mental Health (NIMH) intends to commit $300,000 to fund 3-5 awards.