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.
Other Project Requirements
Your project should establish a collaborative cross-disciplinary team, including immunology and product development experts.
More research is needed to elucidate the mechanisms of action and immunological impact of controlled-release vaccine delivery, including how to calibrate vaccine release to improve the quality, potency, and durability of the immune responses while avoiding immune exhaustion and over-activation. Therefore, proof-of-principle studies in animal models should include a comprehensive and longitudinal assessment of the immunological mechanisms in blood, tissues, and mucosa. Proof-of-principle studies should also include a robust benchmark (current optimal vaccine) studied longitudinally in parallel to the new platform(s) to identify differences due to the controlled-release administration versus a better antigen or adjuvant.
Applications must involve a translational partner with product development expertise to capitalize on existing controlled-release technologies. Applications must address the considerable challenges in optimizing formulations for efficacy, safety, injectability, and/or manufacturing at scale and exploring the development of safe and thermally stable formulations for single-shot or simplified dosing regimens for translation into clinical applications. Advancing safe, effective, and well-tolerated practical solutions for controlled delivery of vaccines is an unmet need that may improve vaccine effectiveness, vaccine regimen practicality, and drug uptake; improve adherence; improve pharmacokinetics; reduce adverse reactions; and save costs.
Proposed projects can be early or later in product development. Defining the stage of product development will justify, for example, focusing the application on early-phase approach optimization and testing in appropriate animal models versus focusing on the product development process and regulatory considerations.
Regardless of whether you include preliminary data, your application should support its proposed approach with scientific literature, scientific discoveries in other fields that would apply to the HIV vaccine field, progress in methodological or technical barriers to advancing the area, or other inferential data.
Investigators are encouraged to integrate behavioral research addressing product end-user preferences. The National Institute of Mental Health (NIMH) is also participating in this NOFO, with the aim of supporting that research effort.
Milestones and Timelines
Applications must include timelines and milestones, particularly around defining relevant antibody or T cell/innate outcomes using appropriate animal models to progress into product development, maintaining the structure/bioactivity of the antigen and adjuvant, and/or achieving the desired release kinetics.
As part of the preaward process, the Milestone Plan may be negotiated, as necessary. NIAID will use the timelines and milestones to evaluate progress throughout the award period. We will consider applications without a Milestone Plan to be nonresponsive and not review them.
Nonresponsive Criteria
NIAID will consider nonresponsive and not review the following types of applications:
- Approaches that do not include HIV immunogens.
- Approaches focused only on strategy improvements.
- Approaches using broadly-neutralizing antibodies, therapies, or viral vectors.
- Lacking a translational partner.
Application Logistics
NIAID plans to fund three to five awards.
The maximum project period you can request is 5 years. Your application budget is not limited but must reflect the actual needs of your planned project.
Applications are due on July 30, 2024, by 5 p.m. local time of the applicant organization.
Direct questions about this NOFO to Dr. Angela Malaspina, NIAID’s scientific contact, at angela.malaspina@nih.gov or 301-825-3859. Additionally, you can reach out to Dr. Teri Senn from NIMH at teri.senn@nih.gov or 301-605-4146 to discuss matters related to behavioral research. For questions regarding peer review, contact Dr. Barry Margulies at barry.margulies@nih.gov or 240-552-1324.