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September 2023 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.

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

Table of Contents

Fiscal Year (FY) 2024 Division of AIDS (DAIDS) Concepts

FY 2025 DAIDS Concepts

Competing Revisions of Existing NIH Centers for AIDS Research (CFAR) and Developmental Centers for AIDS Research (DCFAR) Grants

Program Announcement with Special Receipt, Referral, and/or Review Considerations—proposed FY 2024 initiative

Contact:
Eric Refsland
eric.refsland@nih.gov

Objective: NIAID is soliciting revision applications to active NIH Centers for AIDS Research (CFAR) and Developmental Centers for AIDS Research (DCFAR) grants to support studies and infrastructure that develop the next generation of HIV investigators. NIAID seeks to promote diversity in all its training and research programs and to enhance the diversity of the investigator pool, including participation by investigators from underrepresented groups to develop a highly competent and diverse scientific workforce capable of conducting state-of-the-art research in priority areas of HIV research. A diverse NIH-supported scientific workforce fosters scientific innovation, enhances global competitiveness, and increases the likelihood that underserved or health disparity populations participate in and benefit from health research. NIH encourages applicants to diversify their student and faculty populations through means consistent with applicable law to enhance the participation of individuals from underrepresented groups (refer to NOT-OD-20-031, Notice of NIH’s Interest in Diversity, and NOT-OD-22-019).

Description: The funded revisions will propose programs to expand the role of the CFAR and DCFAR Developmental Cores to include additional support and infrastructure to diversify approaches, investigators, and research into HIV-related health disparities. Applicants are encouraged to initiate or expand collaborations with:

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
  • Resource-limited institutions
  • Institutions conducting HIV research in low- and middle-income countries

CFARs and DCFARs are not allowed to conduct clinical trials. Revisions proposing clinical trials are not responsive.

Notice of Special Interest (NOSI)—Ending the HIV Epidemic (EHE)

For the published notice of special interest, check the September 29, 2023 Guide notice, Notice of Special Interest (NOSI): Ending the HIV Epidemic (EHE).

Strategies for Eliminating HIV Proteins

Request for Applications—proposed FY 2025 initiative

Contact: 
Gerard Lacourciere
gerard.lacourciere@nih.gov

Objective: The objective of this initiative is to support the development of novel therapeutics directed to intracellular HIV targets. During the HIV life cycle, multiple virus-associated proteins are expressed in the infected cell. All are critical to one or another phase of assembly, maturation, or release of the virus. Considering that each protein has a defined role in the life cycle, targeting one or more for elimination may be an effective strategy to obtain a sustained viral remission or cure.

Description: This initiative introduces a new drug discovery paradigm for HIV: controlling virus replication by eliminating viral proteins. The most direct strategy is to eliminate one or more virus-associated proteins from the cell by targeting HIV RNA transcripts with small molecules. Small molecules could inhibit RNA splicing, block translation, or enable the degradation of RNA encoding selected viral proteins. Alternatively, viral proteins can be selectively targeted for degradation by harnessing one of several known cellular processes. These strategies may overcome the limitations of small molecule inhibitors of HIV enzymes by expanding the number of potential targets within an infected cell.

This funding opportunity will support single-project basic research grants that develop novel therapeutics directed to intracellular HIV targets by various mechanisms including but not limited to protein degradation, targeting of viral RNA through inhibiting RNA processing (splicing, translation, etc.) as well as degradation.

This initiative will not support the development of small molecule inhibitors of HIV enzyme activity and molecules that enhance latency reversal, or animal studies using nonhuman primates.

Limited Interaction Targeted Epidemiology: Epidemiology of Transmission and Treatment of HIV Among Vulnerable Populations in Latin America (LITE-LA)

Request for Applications—proposed FY 2025 initiative

Contact:
Lori Zimand Abramson
lzimand@niaid.nih.gov

Objective: The main objective of this initiative is to support large, electronically-generated cohorts in Latin America of men who have sex with men (MSM) and transgender women (TGW) who are HIV-negative and follow them to study the epidemiology of HIV incidence. Continued follow-up of those persons who become HIV-positive should be conducted to study the epidemiology of viral suppression. Comparisons of participants by seroconversion status will provide information on geographic and socially defined areas of high HIV incidence as well as on both personal and structural vulnerabilities to HIV infection. Among participants who seroconvert, comparisons of those becoming rapidly engaged in care and who reach non-detectable HIV levels to those whose virus remains detectable will inform on the treatment of HIV in Latin American countries. The request for applications will allow digital trials to determine optimal study approaches, or to pilot evidence-based digital (mHealth and online) HIV prevention and treatment interventions to both reduce HIV incidence and improve treatment in the most vulnerable populations.

Description: Increasing knowledge about HIV epidemics in Latin America is crucial to addressing these epidemics. Smart phones, the internet, and other technologies have changed the ways that MSM and TGW meet and interact and offer new approaches to track and gather information from these populations. Gay dating apps were successfully used in U.S.-based LITE studies to enroll large cohorts of HIV-negatives highly vulnerable to infection. Epidemiology studies that use these and other remote technologies have been able to identify “hot-spots” of HIV infection and subgroups of the most vulnerable MSM and TGW who can be prioritized for HIV prevention programs.

These same remote methods, including gay dating apps, are also feasible in Latin America and would be likely to generate important HIV research findings relevant to improving prevention and treatment programs there. Information from proposed studies on risk factors for HIV among Latin Americans may also be relevant to HIV prevention and treatment among persons of Latin American origin living in the United States, a major risk group for HIV.

This initiative will require involvement of an investigator currently residing in each country where research is conducted. Investigators from the United States may be included, but this is not required. The involvement of in-country investigators and the likely involvement of Latin American investigators living in the United States would support the diversity of investigators funded by NIH.

Projects must establish large, electronically accessioned cohorts (with adequate statistical power for conducting epidemiologic research (minimum 5,000 participants) during the first 2 years of funding.

This funding opportunity uses a two-phase grant mechanism (UG3/UH3). The Phase 1 UG3 plan must specify Go/No Go Criteria with the number of participants to be enrolled, anticipated retention level, and number of HIV seroconversions expected in the initial 2-year period. These criteria will be subject to negotiation prior to award. Evaluation of criteria for enrollment and seroconversion will determine eligibility for transition to Phase 2 UH3 awards. If criteria are met, recipients may receive an additional 3 years of support to conduct epidemiological research. Non-investigational new drug behavioral interventions and trials may be included during Phase 2 but are not required.

Investigators will be expected to participate in an annual meeting with other funded investigators and with NIH staff.

Gender-Affirming Hormone Therapy, Resilience, Immunology, Pharmacokinetics (GRIP)

Request for Applications—proposed FY 2025 initiative

Contact: 
Cherlynn Mathias
cmathias@niaid.nih.gov

Objective: The specific objective of this request for applications is to support critical research needed to inform strategies to prevent and treat HIV and other sexually transmitted infections (STIs) in transgender people. There are many medical and surgical interventions that transgender people undergo as part of gender affirmation that might impact the acquisition and treatment of HIV or other STIs. Despite a growing body of data indicating that gender-affirming hormone therapy (GAHT) may impact the effectiveness of biomedical HIV prevention or treatment strategies, few studies have addressed these issues in this population. For many transgender people, resilience may include the act of affirming one’s gender in a society in which they face significant stigma and many social systemic challenges. Understanding their needs and specifically tailoring programs to transgender people is critical for strengthening resilience and for more effectively addressing comprehensive HIV and other STI prevention in this population.

This initiative directly addresses the Office of AIDS Research priority area of increasing research to reduce health disparities in the incidence of new HIV infections or in treatment outcomes of those living with HIV/AIDS. It is also responsive to the NIH Sexual and Gender Minority (SGM) Research Office Strategic Plan priority to expand the knowledge base of SGM health through NIH-supported research, as well as the NIH-Wide Strategic Plan for Diversity, Equity, Inclusion, and Accessibility (DEIA).

Description: This initiative will support the following research topics:

  • The impact of GAHT on biomedical regimens used for HIV prevention or treatment and/or co-infections with other STIs.
  • Studies of pharmacokinetics/pharmacodynamics, including metabolism, and drug-drug interactions between GAHT and antiretrovirals (ARV’s).
  • Development of new models (in vitro, ex vivo, in vivo, and in silico) to study the impact of GAHT on the immunology, pharmacology, and safety/efficacy of HIV prevention and treatment regimens and/or co-infections with other STIs.
  • The impact of feminization and masculinization regimens on the gastrointestinal (GI) and urogenital mucosa and their role in HIV and STI susceptibility, infection, and acquisition.
  • Hypothesis-driven “Omic” studies (e.g., metabolomic, proteomic, transcriptomic, microbiome) and the use of systems biology tools to characterize the impact of the feminizing and masculinizing hormones on HIV susceptibility, including in the GI and urogenital tracts.
  • Studies on the determination of active levels of GAHT to address potential variations related to diverse sources of external hormones and various physiological as well as pathophysiological conditions.

Clinical trials will NOT be allowed for this initiative.

Long-Acting Drug Delivery Systems for ART Optimization in Children Living with HIV-1 II (LADDS II)

For the published request for applications, check the October 25, 2023 Guide announcement, Long-Acting Drug Delivery Systems for ART Optimization in Children Living with HIV-1 II (LADDS II) (R61/R33, Clinical Trial Not Allowed).

Engineering Durable HIV Vaccine Responses (ENDURE)

Request for Applications—proposed FY 2025 initiative

Contact:
Amy Palin
amy.palin@nih.gov

Objectives: Waning vaccine efficacy against SARS-CoV-2 and consequent boosting have highlighted the importance of durable vaccine responses. How vaccines induce durable responses remains unclear, and there is no consensus on the definition of durable protection. As vaccine candidates for HIV improve, understanding vaccine durability will become more critical, particularly given the booster-weary population. By integrating bioengineering and immunology, this funding concept addresses several objectives: 1) identification of signatures and markers of durable vaccine responses, 2) identification of early immune signals for programming durable vaccine responses, and 3) application of this knowledge to development of more durable vaccines. Predictors or biomarkers of durable responses can expedite clinical trials and vaccine development by establishing immunologic endpoints for regulatory decisions. Such endpoints can accelerate approval of an efficacious vaccine for expansion to a new population or approval of a refined version of an existing vaccine.

Description: This funding concept will support multi-disciplinary R01 research, inclusive of studies of human immunology and appropriate animal models. Clinical trials will not be allowed. Use of samples from trials funded through other mechanisms will be allowed. Applications must propose hypothesis-driven studies of candidate vaccines for HIV. Areas of interest include: 

  • Defining durable vaccine responses
    • Identification of molecular signatures, biomarkers, and/or predictors of durable responses
    • Studies of the immunology of durable responses
    • Investigation of acute innate and adaptive immune responses that program durable vaccine responses
    • Comparison of platforms, delivery methods, routes of administration, doses, schedules, and other parameters to identify requirements for durable response
  • Measuring durable vaccine responses
    • Development of assays and techniques to measure durable responses (e.g., sampling methods for bone marrow or mucosal tissues, sample processing methods, analytic tools and methods)
    • Identification and application of molecular signatures, biomarkers, and/or predictors of durable responses
  • Engineering durable vaccine responses
    • Engineering and optimization of antigen display, presentation, and other vaccine parameters
    • Induction of long-lived germinal center, plasma cell responses, and/or other memory responses

The scope will not include applications focusing on vaccines for pathogens other than HIV, strategies focused on immunogen development or optimization, strategies primarily focused on increasing breadth, strategies employing host cell engineering, or antibody engineering and passive immunization.

Strategies for Controlled Release of HIV Vaccines (SCORE-H)

Request for Applications—proposed FY 2025 initiative

Contact: 
Angela Malaspina
angela.malaspina@nih.gov

Objectives: This new initiative aims to advance controlled-vaccine release strategies to improve immune responses for HIV prevention, treatment, and cure and develop simplified or single-shot vaccination strategies.

Although HIV vaccine antigens and adjuvants still require optimization and selection, advancing safe, effective, and well-tolerated solutions for the controlled release of vaccines is an unmet need that may improve vaccine effectiveness and practicality, leading to better adherence to complex regimens, fewer adverse reactions, and cost savings.

Description: The scientific objective of this initiative is to capitalize on advances in materials science, novel release technologies, and delivery systems that may provide new solutions to enhance vaccine response quality, potency, and durability by controlled and customized delivery.

Most conventional subunit vaccines are delivered in bolus, which exposes the immune system to antigens for hours or days before being cleared and often necessitates booster shots to increase immunogenicity. Conversely, natural infections expose the body to inflammation and antigens over days to weeks, often resulting in potent and long-lasting protective immunity. The advantage of materials-based platforms is that they can be engineered to improve the stability and loading of multiple vaccine components and their spatiotemporal release, for example, by controlling the time frame and dose of vaccine delivery over weeks or months. Recent studies have shown that a slow-release vaccine is superior to bolus administration at inducing breadth, potency, and durability of antibody responses to HIV antigens by prolonging antigen exposure in the germinal centers, further enhancing the maturation of B cells for strong humoral immune responses. These findings provide a better understanding of the immunological mechanisms after vaccination and raise critical questions about translating preclinical concepts into clinical applications. Further research is crucial in determining how the targeted delivery and duration of exposure to vaccine components impact the interaction with the immune cells, including how to calibrate vaccine release for improved responses while avoiding exhaustion and over-activation. Therefore, given the recent advances in bioengineering and immunology, it is timely to investigate delivery approaches for controlled HIV vaccine release to develop protective and durable broadly neutralizing responses and antiviral T-cell/innate responses while the field is still working on improving immunogens.

Specific areas of research interest include, but are not limited to:

  • Evaluate controlled-release vaccine platforms optimized for release kinetics, routes of administration, doses, dosing schedules, and delivery to specific cell types and tissues for improved immune responses.
  • Investigate longitudinally the advantages of the delivery platform(s) against a robust benchmark, as well as their potential detrimental effects.
  • Harness the progress towards controlled-release technologies and thermally stable formulations to develop simplified or single-shot vaccination strategies that mimic multidose regimens, natural infection, or replicating viral vectors.
  • Assess the maintenance of the vaccine structure and bioactivity throughout the delivery period, feasibility for GMP manufacturing, safety, and user acceptability of the optimized delivery platforms.

This notice of funding opportunity will use a biphasic R61/R33 award mechanism with well-defined, negotiated milestones to determine the transition to the second phase.

Translational partnerships among academia, industry, and government are required.

The addition of a behavioral component is highly encouraged in the R33 phase to begin understanding end-user preferences for the delivery system attributes and using this information to refine development iteratively. The early integration of behavioral science with product and process designs is essential for translating basic science into products with solid uptake and use.

Clinical trials are not allowed. HIV/SIV immunogens must be used. Animal research is required, including the use of HIV, SIV, SHIV, small animal models, and nonhuman primates.
 

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