January 2022 DAIDS Council-Approved Concepts

Concepts represent early planning stages for program announcements, requests for applications, notices of special interest, or solicitations for Council's input. If NIAID publishes an initiative from one of these concepts, we link to it below. To find initiatives, go to Opportunities & Announcements.

NB: Council approval does not guarantee that a concept will become an initiative.

Table of Contents

Fiscal Year (FY) 2023 Concepts

FY 2023 Small Business Innovation Research (SBIR) Contract Solicitation Topics

Notice of Special Interest (NOSI)—Towards Developing a Cure for HBV in HIV/HBV Co-Infection

For the published notice of special interest, check the April 29, 2022 Guide announcement, Notice of Special Interest (NOSI)—towards Developing a Cure for HBV in HIV/HBV Co-Infection.

Notice of Special Interest (NOSI)—Next Generation Multipurpose Prevention Technologies

Notice of Special Interest—proposed FY 2023 initiative

Contact:
James Cummins
cumminsje@niaid.nih.gov

Objective: NIAID has a specific interest in the continued development of multipurpose prevention technologies (MPTs) for prevention of pregnancy and sexually transmitted infections (STIs). The overarching objective will be the continued expansion of a pipeline of MPT candidates.

Description: The focus will be on licensed contraceptives combined with anti-HIV drugs (licensed or unlicensed). Applicants may propose any combination of a prevention and contraception product that uses a sustained release platform to provide the minimal windows of efficacy/protection identified below. Proposed MPT approaches must address a minimal window of protection of 30 days or 1 menstrual cycle from either a single dose regimen (injection) or continuous dosing regimen (implant, transdermal patch, etc.). Development of longer durations of protection and durations congruent when a licensed contraceptive is incorporated into the MPT will continue to be encouraged. Co-packaging as a MPT strategy of an existing licensed hormonal contraceptive and a licensed antiviral strategy will be discouraged. Clinical trials are optional. When a clinical trial(s) is/are proposed, they are expected to concentrate on the identification of Preferred User Characteristics (PUC) to increase potential user adherence. PUC are defined as the look and feel properties of the sustained drug delivery system that will influence potential user decisions for initial, continued, and habitual use. Clinical trials solely for First-in-Human (FIH) testing and/or to determine the safety/efficacy of proposed MPTs will be discouraged.

Notice of Special Interest (NOSI)—Sustained Release of Antivirals for Treatment or Prevention (SRATP)

For the published notice of special interest, check the April 29, 2022 Guide notice, Notice of Special Interest (NOSI)—Sustained Release of Antivirals for Treatment or Prevention of HIV or Treatment of Latent TB/HBV (SRATP).

Notice of Special Interest (NOSI)—Transgender People—Immunity, Prevention, and Treatment of HIV and STIs

For the published program announcement with special receipt, referral, or review considerations, check the May 10, 2022 Guide announcement, Transgender People—Immunity, Prevention, and Treatment of HIV and STIs (R21, Clinical Trial Not Allowed).

Notice of Special Interest (NOSI)—Identifying Immune Cell Death Pathway Targets for Host-Directed Therapies for Treatment of Mtb and Mtb/HIV Co-Infection

Notice of Special Interest—proposed FY 2023 initiative

Contact:
Josh Radke
josh.radke@nih.gov

Objective: NIAID has a specific interest in research toward understanding the role cell death mechanisms (CDMs) play in response to Mycobacterium tuberculosis (Mtb) infection, how Mtb subverts cell death pathways to promote infection, and to identify cellular targets that could be exploited as potential host-directed therapies to treat Mtb and Mtb/HIV co-infection.

Description: CDMs include 1) non-inflammatory mechanisms (apoptosis) that promote clearance of dying, damaged, or infected cells to maintain healthy tissue micro-environments and 2) inflammatory mechanisms (pyroptosis, necrosis, necroptosis) that release pathogens and pro-inflammatory molecules from dead cells leading to tissue damage and chronic disease. Understanding how host CDMs interact with each other and components of the immune system and how those interactions influence the effectiveness of the host response to Mycobacterium tuberculosis (Mtb) and Mtb/HIV co-infections will identify new targets that can be developed as host-directed therapies. Small molecule/drug approaches that promote apoptotic cell death without inducing a damaging inflammatory response have been shown to improve treatment outcomes in animal models improving Mtb elimination with less associated tissue damage. CDMs also act as second messengers that guide both development of more effective immune reactions and tissue micro-environment changes to ensure tissue repair and homeostasis during infections. In addition, cell death-related mechanisms have a direct inhibitory effect on some intracellular pathogens and are involved in the selective clearance of HIV-1-infected CD4+ T cells. Emerging evidence indicates that stimulation of CDM pathways and damage-associated molecular patterns (DAMPs) by vaccines/adjuvants have a role in the development of immunogenicity.

Specific interests include:

  • Basic biological mechanisms of how Mtb modulates cell death pathways to promote infection, inflammation, cell necrosis, and tissue damage
  • Characterizing interactions between CDMs and with other cell death-associated events (e.g., DAMP release) in the context of Mtb and Mtb/HIV infections
  • Delineating interactions of CDMs with elements of the innate and adaptive immune systems during Mtb infection and the impact on host response effectiveness
  • Identifying novel host cell death-related mechanisms involved with Mtb or Mtb/HIV co-infection
  • Identifying and evaluating targets and agents for novel host-directed therapies
  • Use of in vitro human multi-cell type and animal models is preferred over single cell type approaches

Research focused on bacterial cell death mechanisms and pathways are not included. 

Clinical trials are not included.

Resources Access for Preclinical Integrated Drug Development (RAPIDD) Program

For the published program announcement with special receipt, referral, or review considerations, check the May 27, 2022 Guide announcement, Resources Access for Preclinical Integrated Drug Development (RAPIDD) Program (X01, Clinical Trial Not Allowed).

Development of a Simian Immunodeficiency Virus (SIV) and Simian Human Immunodeficiency Virus (SHIV) Database

Note: NIAID new topic proposed for NIH SBIR contract solicitation PHS 2023-1.

Request for Proposals

Contact
Charles H. Jackson, Jr.
charles.jackson@nih.gov

Point-of-Care HIV Viral Load and Drug Adherence Assays To Accelerate “Ending the HIV Epidemic (EHE)”

Note: NIAID reissued topic proposed for NIH SBIR contract solicitation PHS 2023-1.

Request for Proposals

Contact
Charles H. Jackson, Jr.
charles.jackson@nih.gov

Development of Assays To Differentiate HIV Infection From Seropositivity Induced by HIV Vaccines

Note: NIAID reissued topic proposed for NIH SBIR contract solicitation PHS 2023-1.

Request for Proposals

Contact
Charles H. Jackson, Jr.
charles.jackson@nih.gov

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