NIAID’s new notice of funding opportunity (NOFO) Strategies for Controlled Release of HIV Vaccines (SCORE-H) (R01, Clinical Trial Not Allowed) supports 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.
Through this NOFO, we will fund product-focused research to advance controlled-release vaccine strategies shown to improve immune responses for HIV prevention, treatment, and cure, and also to develop simplified or single-shot vaccination formulations. Successful applicants will propose timelines with measurable milestones.
Recent advances in bioengineering and immunology should enable novel delivery approaches for controlled HIV vaccine release while the HIV field is developing immunogens. 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 good manufacturing practice (GMP) manufacturing.
- 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.