June 2021 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) 2022 Concepts

FY 2022 Small Business Innovation Research (SBIR) Contract Solicitation Topic

FY 2023 Concepts

Brazil Regional Prospective Observational Research in Tuberculosis (RePORT)

For the published program announcement with special receipt, referral, or review considerations, see the August 5, 2021 Guide announcement, Brazil Regional Prospective Observational Research in Tuberculosis (RePORT) (U01, Clinical Trial Not Allowed)

Notice of Special Interest (NOSI)—HIV Drug Resistance Assays and Actionable Data Dissemination Strategies

For the published notice of special interest, check the June 17, 2021 Guide notice, Notice of Special Interest (NOSI)—HIV Drug Resistance Assays and Actionable Data Dissemination Strategies.

Notice of Special Interest (NOSI)—HIV/AIDS in the Era of COVID-19 - When Pandemics Collide

For the published notice of special interest, check the June 25, 2021 Guide notice, Notice of Special Interest (NOSI)—HIV/AIDS in the Era of COVID-19 - When Pandemics Collide.

Development of Diagnostics To Differentiate HIV Infection From Vaccine-Induced Seropositivity

For the published request for proposals, check the July 30, 2021 solicitation, A Solicitation of the National Institutes of Health (NIH) and The Centers for Disease Control and Prevention (CDC) for Small Business Innovation Research (SBIR) Contract Proposals.

Development of Assays for Testing Susceptibility to Broadly Neutralizing Antibodies (bNAbs)

Request for Applications—proposed FY 2023 initiative

Contact: Keith Crawford

Objective: This initiative will enable development of assays that can easily measure the susceptibility of HIV to broadly neutralizing antibodies (bNAbs). The assays will be capable of measuring susceptibility of HIV isolates from viremic individuals as well as susceptibility of HIV reservoirs in people who are virologically suppressed on antiretroviral therapy (ART). Because the assays will be used for enrolling participants into clinical trials and potentially for testing patients prior to bNAb clinical use, the final product must be appropriate for use in clinical laboratories under Clinical Laboratory Improvement Amendments (CLIA) regulations.

Description: This initiative will support research targeting early-stage development of innovative technologies designed to enable the measurement of susceptibility to bNAbs in clinical laboratories. Proposed studies are expected to be at the early discovery, development, and feasibility stage to show potential efficacy. Proposed studies should emphasize innovation and exploratory research. These projects will require collaboration among experts in the fields of virology and biotechnology (e.g., sequencing, microfluidics, bioengineering, synthetic biology, nanotechnology, machine learning, clinical laboratory procedures and regulations). Investigators must have access to appropriate virus and biospecimen resources. Clinical trials are not allowed but use of samples from clinical trials supported elsewhere are allowed.

South Africa Regional Prospective Observational Research in Tuberculosis (RePORT)

Request for Applications—proposed FY 2023 initiative

Contact: Sudha Srinivasan

Objective: The primary objective of this initiative is to enable a network of South African and U.S. scientists to advance current understanding of the community, host, and microbial factors that impact outcomes of tuberculosis (TB) infection and TB disease, especially among persons with HIV (PWH), including drug-resistant TB, to facilitate development of tools to improve treatment outcomes at the individual level and to inform strategies to curtail the TB epidemic at the public health level.

To achieve this, the initiative will support a South Africa-U.S. Regional Prospective Observational Research in Tuberculosis (RePORT) network that will leverage the robust clinical research infrastructure that exists within South Africa to capacitate this research.

Description: To advance high-priority research for the United States and the South Africa Medical Research Council (SAMRC), applicants will leverage clinical samples and data from existing prospective longitudinal cohorts that include participants with active TB disease and their contacts.

Research projects supported through this initiative may include, but are not limited to, the areas below. The priorities will be further delineated in collaboration with the SAMRC.

  • Studies to identify/validate biomarkers and biosignatures for TB progression risk/prevention, diagnosis, prognosis, and treatment monitoring
  • Discovery/confirmation of host and microbial factors that affect the development risk, dynamics, pathophysiology, outcomes, and transmission of active TB and TB/HIV in children and adults
  • Studies to support new and continued development of TB vaccines
  • Observation and implementation studies that bridge the knowledge-practice gap in TB and TB/HIV diagnosis, treatment, and prevention

This initiative will not support the following:

  • Collection of only epidemiological data
  • Establishment of de novo clinical cohorts
  • Clinical trials

If additional clinical specimens and data are needed to answer the research proposed, the applicant may propose to collect additional samples and data. In this case, the applicant is required to leverage existing infrastructure, and must have the capacity to implement the observational research as per the RePORT International standards. It is expected that the successful applicant for the RePORT South Africa Network will participate in the international effort to advance TB research with a focus on research to improve the health of PWH including participation in the RePORT International Consortium. 

Applicants must develop a method to establish and/or maintain a collaboration with the Southern Africa International epidemiology Databases to Evaluate AIDS (IeDEA) network in order to facilitate standardized collection and sharing of TB/HIV epidemiological and clinical data.

RePORT International Coordinating Center (RICC)

Request for Applications—proposed FY 2023 initiative

Contact: Sudha Srinivasan

Objective: The primary objective of this initiative is to advance tuberculosis (TB) and TB/HIV research by supporting coordination of global research efforts undertaken by the various in-country Regional Prospective Observational Research for Tuberculosis (RePORT) networks and other research partners. The RePORT International Coordinating Center (RICC) enables coordination and acceleration of research across the six RePORT countries (India, Brazil, South Africa, China, Indonesia, and Philippines) and fosters a synergistic approach. This will allow for maximizing resources, validating research findings, and generating globally applicable research outcomes in a timely manner.

Description: RePORT is a consortium of six regional research networks based in high TB/HIV-burden countries (Brazil, China, India, Indonesia, Philippines, and South Africa). Each network functions independently of one another but with the common goal of advancing regional and global TB and TB/HIV science, and strengthening local research capacity and infrastructure.

This initiative will support a research coordination hub to facilitate trans-RePORT communication and collaboration on research and other work of interest to the member RePORT Networks. The RICC will also oversee development and maintenance of various RePORT International standards and best practices including data and laboratory standards, data transfer protocols, and data sharing agreements. The RICC will consist of: 

  • An executive leadership team representing investigators from all the individual RePORT country consortia
  • Scientific working groups to delineate research projects of interest to RePORT Network members
  • A data management center that will support multi-regional data workflow, data coding standards and sharing across consortia, and develop a hub which can continue to establish and support data harmonization
  • Laboratory working group to assist with specimen management and laboratory resources across the sites
  • Other working groups and structures needed to: 
    • Identify and catalyze joint research activities with new research entities and other multinational networks
    • Host and organize the annual scientific RePORT International meeting
    • Host and maintain the RePORT International website
    • Encourage building of research capacity of RePORT regions, which includes mentoring and career development of junior investigators

In addition to the infrastructure described above, the RICC may undertake research in collaboration with one or more regional RePORT Networks to address a number of high-priority research areas, including: 

  • Studies to investigate diversity of factors, both human and bacterial, which influence TB disease risks and treatment outcomes
  • Lab-based and observational studies that contribute to developing TB vaccines
  • Studies to develop and validate diagnostics across the consortia

Biomarker Signatures of Tuberculosis Infection in Young Children With and Without HIV

Request for Applications—proposed FY 2023 initiative

Contact: Patrick Jean-Philippe

Objective: The goal of this initiative is to advance research to discover and validate novel biomarkers of tuberculosis (TB) infection and subsequent risk of progression to TB disease in young children with and without HIV.

Description: This initiative will support discovery and validation research for biomarkers and biomarker signatures that can identify children less than five years of age with TB infection and predict those more likely to progress to active TB disease, allowing targeted treatment to those at risk of progression. Identified biomarkers signatures enable potential translation to simple, rapid, inexpensive, hand-held point-of-care-based tools for use by minimally trained health workers, within/outside contact tracing settings. However, development of diagnostic assay/technology for a point-of-care test is not within the scope of this initiative.

All applications must include a biomarker discovery approach. Applicants must leverage state-of-the-art laboratory approaches such as single cell multi-omics technologies and similar approaches to perform unbiased high-resolution profiling, including but not limited to, RNA expression profiling, proteins profiling, immune cells profiling, DNA methylome profiling, system serology/Fc glycosylation profiling, and other appropriate cutting-edge methods. Integrative, multi-modality approaches across various non-sputum matrix types are encouraged. Use of cutting edge statistical and computational methods is expected.

Additionally, applicants must propose at least one additional approach to confirm or refine biomarker signatures identified in the biomarker discovery approach. Such projects can include evaluation of biomarker signatures that have shown promise in adults populations [i.e., meeting at least the World Health Organization published minimum target product profile (TPP) criteria for tests of TB infection and/or TB disease progression] or use of model systems, animal models, or other activities (ex vivo, in vitro, in silico) to probe biomarker pathways, uncover relevant biologic mechanisms, and increase the precision of discovered biomarkers. 

The target population is children less than five years of age and must include children living with HIV. Young children exposed to HIV perinatally meet the definition of living with HIV for the purpose of this initiative. Children neither living with nor exposed to HIV are also allowed. Cohorts should include young children at risk for TB through suspected/documented exposure or living in high TB incidence settings with high rates of tuberculin skin tests conversion in young children. 

Applicants must have access to well-characterized biobanks and datasets from the target population or access to ongoing, prospective longitudinal observational cohorts of young children at risk for TB acquisition, whether in the context of documented TB exposure/TB index contact or non-contact tracing settings with anticipated high incidence of TB infection. Biobanks or prospective cohorts should include sufficient numbers of participants and TB outcomes to allow for valid, rigorous observations in training sets and confirmation in separate validation sets. Rigorous methodological approaches, including use of appropriate controls and accounting for confounders, sound diagnostic approaches, and rigorous classification of active TB disease and TB infection cases, should be employed to allow accurate interpretation of findings and biomarker characterization. Biomarker evaluation must abide by accepted standards for diagnostics/index tests evaluation. De novo prospective observational cohorts establishment are not permitted. Clinical trials are not allowed.

Resources To Advance Pediatrics and HIV Prevention Science (RAPPS)

Request for Proposals—proposed FY 2023 initiative

Contact: Robert Corno

Objective: The primary objective of this contract initiative is to provide drug development resources to support advancement of the next generation of HIV non-vaccine biomedical prevention (nBP) products and HIV treatment and prevention strategies in maternal, pediatric, adolescent, and adult populations. The RAPPS contract will support academic institutions, pharmaceutical companies, and nongovernment organizations that are 1) planning clinical development of their product and/or 2) either independently or in partnership with NIAID pursuing a product licensure effort.

Description: The RAPPS contract will allow the government to provide contract support for emerging strategies to meet the evolving needs of the DAIDS Prevention Sciences Program (Program) in three areas: 

  • Advancing promising next generation non-vaccine HIV biomedical prevention products into human clinical testing
  • Expanding marketing science and user preference studies to better understand desire/choice and how best to engage women and men in HIV prevention
    • Emphasis on adolescent girls and young women ages 14 to 25 years old
  • Providing gap-filling resources to support HIV prevention and treatment strategies in maternal and pediatric/adolescent populations
    • Includes age-appropriate formulations and co-infections/comorbidities
    • Includes treatment/prevention strategies in newborns/infants

The proposed structure of the RAPPS contract is based on lessons learned from the “Comprehensive Resources for HIV Microbicides and Biomedical Prevention” contract that is expiring in FY 2023. The RAPPS contract will be an indefinite delivery/indefinite quantity (ID/IQ) task order-based contract with activities in the following five areas:

  1. Preclinical gap-filling services: These services include support for in vitro testing, animal safety models, or other product-specific activities that are required to advance products into clinical testing including, when required, compliance with Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP), or non-GLP/GMP activities considered acceptable for inclusion in investigational new drug or new drug applications.
  2. HIV animal models supporting product development: These services include performance of pharmacokinetic, safety, and efficacy studies in relevant animal models for SIV/HIV transmission or pathogenesis.
  3. Bioanalytical product support services: These services include development and validation of analytical methods in support of in vitro, ex vivo, and in vivo safety, pharmacokinetic, and pharmacodynamic studies, and are performed with the level of quality oversight that is necessary to meet all applicable regulatory requirements.
  4. Product manufacturing: These services include GMP manufacturing and support activities to produce drug substance or final product for use in non-GLP, GLP, and clinical (i.e., Good Clinical Practice) activities.
  5. Scientific and quality/regulatory support services: The RAPPS contract will support activities designed to define project scopes and requirements necessary to advance products. These activities may include engaging subject matter experts as consultants or interfacing with experts in the field through contract-sponsored think tanks, best practices working groups, or topic-specific consultations. Under this task area, the RAPPS contract will also provide quality assurance and oversight for activities conducted in the above task areas including GLP/GMP-compliant centralized storage and handling of drug products and archived materials.

The RAPPS contract will support both vertebrate animal research and NIH-defined clinical research studies. At this time, it is not envisioned that the RAPPS contract will conduct NIH-defined clinical trials. The RAPPS contract will not conduct studies with humanized animal models unless policy is changed to allow their usage.

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