June 2019 DAIDS Council-Approved Concepts

Concepts represent early planning stages for program announcements, requests for applications, 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 2021 Concepts

Centers for AIDS Research

Program Announcement With Special Receipt, Referral, and/or Review Considerations—proposed FY 2021 initiative

Contact: Candice Beaubien

Objective: The mission of the Centers for AIDS Research (CFAR) program is to support multidisciplinary research aimed at reducing the burden of HIV both in the United States and around the globe. The continuing spread of HIV in the United States and globally underscores the need for ongoing, nationally coordinated, collaborative conduct of basic, clinical, epidemiologic, behavioral, and translational research to improve the prevention, detection, treatment, and cure/remission of HIV infection and the associated complications/co-morbidities.

Description: The CFAR program supports diverse core facilities (versus grant projects) to carry out HIV/AIDS research at eligible institutions having substantial NIH-funded HIV research and a critical number of NIH-funded investigators who are performing high-quality HIV/AIDS research. The Developmental CFAR (D-CFAR) provides funding for institutions that are not yet competitive for a standard CFAR to build and strengthen any deficiencies that might adversely affect an application for a standard CFAR award and to ultimately lead to developing a competitive standard CFAR application. Both D-CFAR and standard CFAR applications must include an administrative core, a developmental core, and at least one clinical science core and one basic science core and one to three scientific working groups. The developmental core provides support for early-career and new investigators in HIV/AIDS research including mentorship and pilot studies. Pilot awards vary in the type of research from basic science to clinical research, but clinical trials are not allowed.

Developmental Centers for AIDS Research

Program Announcement With Special Receipt, Referral, and/or Review Considerations—proposed FY 2021 initiative

Contact: Candice Beaubien

Objective: The mission of the Centers for AIDS Research (CFAR) program is to support multidisciplinary research aimed at reducing the burden of HIV both in the United States and around the globe. The continuing spread of HIV in the United States and globally underscores the need for ongoing, nationally coordinated, collaborative conduct of basic, clinical, epidemiologic, behavioral, and translational research to improve the prevention, detection, treatment, and cure/remission of HIV infection and the associated complications/co-morbidities.

Description: The CFAR program supports diverse core facilities (versus grant projects) to carry out HIV/AIDS research at eligible institutions having substantial NIH-funded HIV research and a critical number of NIH-funded investigators who are performing high-quality HIV/AIDS research. The Developmental CFAR (D-CFAR) provides funding for institutions that are not yet competitive for a standard CFAR to build and strengthen any deficiencies that might adversely affect an application for a standard CFAR award and to ultimately lead to the development of a competitive standard CFAR application. Both D-CFAR and standard CFAR applications must include an administrative core, a developmental core and at least one clinical science core and one basic science core and one to three scientific working groups. The developmental core provides support for early-career and new investigators in HIV/AIDS research including mentorship and pilot studies. Pilot awards vary in the type of research from basic science to clinical research, but clinical trials are not allowed.

Martin Delaney Collaboratories for HIV Cure Research

Request for Applications—proposed FY 2021 initiative

Contact: Karl Salzwedel

Objective: This initiative will address major obstacles to the eradication (cure) of HIV infection or long-term antiretroviral therapy (ART)-free control of viral rebound in infected individuals (remission). The goal is to extend our understanding of the basic biology and dynamics of persistent HIV reservoirs; to develop improved assays, methodology, and animal models to expedite research progress; and to design, develop, and test therapeutic strategies for achieving long-term HIV remission or eradication. The collaborative and dynamic structure of the Martin Delaney Collaboratory (MDC) program increases the pace of HIV cure research, leverages common resources, facilitates new collaborations, and engages and trains the next generation of HIV cure researchers.

Description: This initiative will support research partnerships between multiple academic institutions, industry, government, and community-based organizations. Four to six programs will be supported, each with a unique approach toward the scientific objectives. The programs will be encouraged to communicate and collaborate across programs through annual meetings, trans-MDC working groups, and review by a common scientific advisory board overseeing all of the programs.

Each MDC program will involve high-risk/high-reward, innovative basic and translational research on a scale that can be achieved only with highly coordinated collaborations across multiple interdisciplinary teams of researchers. The research plans will be dynamic and evolve over the five years of funding to focus resources on the most innovative basic research and most promising cure strategies. While strategies for control of viral rebound and long-term remission are encouraged, each program must include a research aim focused on overcoming latency through reservoir eradication or inactivation to achieve a sterilizing cure. Leveraging industry partnerships will add a valuable scientific perspective and will ensure that strategies being tested include therapeutics that are available in sufficient quantity and quality (e.g., Good Manufacturing Practice); optimized for potency, specificity, safety, and pharmacokinetics-pharmacodynamics; and have a clear pathway to market. Clinical trials will not be allowed, but trial protocols will be encouraged to be spun out into the DAIDS Clinical Trials Network, unsolicited cooperative agreements (U01s), applications in response to other NIH funding opportunity announcements, studies funded by industry partners, or other funding entity. The rationale is that the trials should build on the basic and translational research developed within the MDC and should not become a distraction from the emphasis on innovative basic research. The program will sunset once the field has reached the point at which multiple clinical trials have demonstrated a sterilizing cure in several participants through a strategy that is safe and scalable to a large population or once multiple trials have demonstrated long-term ART-free remission (>one year) with such a strategy in a majority of patients (>60 percent) with essentially zero risk of transmission to uninfected partners.

Martin Delaney Collaboratory for Pediatric HIV Cure Research

Request for Applications—proposed FY 2021 initiative

Contact: Karl Salzwedel

Objective: This initiative will stimulate research to address major obstacles to the eradication (cure) of HIV infection or long-term antiretroviral therapy (ART)-free control of viral rebound (remission) in infected pediatric individuals. The goal is to extend our understanding of the basic biology and dynamics of persistent HIV reservoirs; to develop improved assays, methodology, and animal models to expedite research progress; and to design, develop, and test therapeutic strategies for achieving long-term HIV remission or eradication specifically in people under 18 years of age. The collaborative and dynamic structure of the Martin Delaney Collaboratory (MDC) program seeks to increase the pace of HIV cure research, leverage common resources, facilitate collaborations, and engage and train the next generation of pediatric HIV cure researchers.

Description: This new initiative will support HIV cure research in pediatric populations through partnerships between multiple academic institutions, industry, government, and community-based organizations. It is anticipated that one pediatric program will be supported. The awardee will be encouraged to communicate and collaborate with the awards made under the companion Martin Delaney Collaboratory program through annual meetings, trans-MDC working groups, and review by a common scientific advisory board overseeing all of the programs.

The pediatric MDC program will involve high-risk/high-reward, innovative basic and translational research through coordinated collaborations across multiple interdisciplinary teams of researchers. The research plans will evolve over the award period to focus resources on the most innovative basic research and most promising cure strategies.

While strategies for control of viral rebound and long-term remission are encouraged, each application must include a research aim focused on overcoming latency through reservoir eradication or inactivation to achieve a sterilizing cure in children. Industry partnerships are encouraged to ensure that strategies being tested are appropriate for the targeted pediatric population, and have a clear pathway to market.

While clinical trials are not allowed, grantees will be encouraged to draft clinical trial protocols that will be spun out into the DAIDS Clinical Trials Network, separate cooperative agreement (U01) applications, or supported by other funding sources.

The program will sunset once the field has reached the point at which multiple clinical trials have demonstrated a sterilizing cure in several participants through a strategy that is safe and scalable to a large pediatric population or once multiple trials have demonstrated long-term ART-free remission (>one year) with such a strategy in a majority of children.

Limited Competition: International epidemiology Databases To Evaluate AIDS (IeDEA)

Request for Applications—proposed FY 2021 initiative

Contact: Carolyn Williams

Objective: The IeDEA network of grant awards brings together HIV clinical and research datasets from world regions to answer key questions about the natural and treated history of HIV infection that can be answered only with large sample sizes. IeDEA validates and harmonizes these data. It develops novel statistical methods to improve the utility of observational data such as accounting for missing data, and understanding and minimizing bias. The goal is to conduct analyses that produce comparable results across regions, combine data from multiple regions to answer compelling questions, and produce patient level surveillance outcomes to monitor program implementation.

Description: IeDEA is an international research network established in 2006 by NIAID to provide a rich resource for globally diverse HIV/AIDS data. IeDEA regional investigators collaborate within and across regions to collect and define key variables, harmonize data, and implement methodology to effectively pool data as a cost-effective means of generating large data sets to address high-priority research questions and streamline HIV/AIDS research.

IeDEA is structured into seven international regional data centers: four in Africa, and one each in the Asia-Pacific region, the Central/South America/Caribbean region, and North America. These regional data centers consolidate, curate, and analyze data on care and treatment of HIV to evaluate the outcomes of people living with HIV/AIDS. The program supports epidemiologists, clinical researchers, data management specialists, and statisticians to conduct research on collected clinical data. Sources of data include cohort studies, clinical trial networks, public and private clinics and hospitals, and private care providers. IeDEA provides training and support to clinical/research staff in country. In 2019, IeDEA launched a Sentinel Research Network (SRN) at key sites within each region. These sites have enhanced patient tracking and clinical testing to better evaluate progress in controlling HIV. At the same time, IeDEA increased support for data harmonization and an international training program. This fourth iteration of the program (IeDEA IV) will enable continued funding for five U.S. institutions and two European universities to conduct research in seven global regions of the world. This renewal also proposes to support increased analytic capacity for the large datasets assembled by the currently funded regions and a continuation of SRN to address key co-infections and co-morbidities. The renewal will also support an expansion of the IeDEA SRN model to tuberculosis (TB) treatment facilities for TB and HIV/TB research globally.

NIAID Specimen Repository

Request for Proposals—proposed FY 2021 initiative

Contact: Kim Brookens

Objective: This initiative continues the critically needed comprehensive services of the NIAID Specimen Repository (NSR), which will continue to 1) secure, receive, catalog, process, aliquot, store, and disburse human biological specimens from subjects participating in DAIDS-sponsored cohort studies and clinical networks; 2) provide adequate cold storage facilities; 3) remain current on novel procedures for optimized storage of clinical specimens and be able to use state-of-the-art technology to ensure specimen integrity from receipt to storage in the freezers and from freezers to shipment containers for outgoing shipments; 4) provide (or use the current) computerized Specimen Inventory Database Management System (SIDMS) that supports the repository's functions; and 5) develop, perform, and maintain quality assurance /quality control program for the NSR facility, operations, stored biospecimens, shipping materials, and personnel in accordance with all applicable federal, state, and local regulatory requirements.

Description: This initiative will serve and support current and future vaccine and epidemiological cohort study groups referred to as Study Groups. The NSR will support the following ongoing NIAID Study Groups, noted in order of greatest to least numbers of stored specimens: Women's Interagency HIV Study (WIHS), HIV Vaccine Trials Network (HVTN), and Multicenter AIDS Cohort Study (MACS). The NSR also will maintain specimens from other NIAID-sponsored studies that either have been completed, such as the AIDS Vaccine Evaluation Group (AVEG), HIV Transmission Network (HIVNET), Jump Start Project, Heterosexual HIV Transmission Study (HATS), Division of AIDS Treatment Research Initiative (DATRI), or from Study Groups that currently send newly-generated specimens to another repository, such as the Adult and Pediatric AIDS Clinical Trials Group.

The NSR will support the short, moderate, and long-term specimen storage needs of the domestic and international Study Groups. Retrieval and distribution of specimens is guided by the scientific priorities of the Executive or Advisory Committees of Study Groups. These specimens include peripheral blood mononuclear cells, serum, plasma, tissue specimens, and other bodily fluids or substances such as cervicovaginal lavage (CVL), semen, saliva, urine, feces, hair, mucosal, autopsy and biopsy materials, and whole blood spots dried on filter paper.

Support will be provided through receiving or shipping specimens to over 300 domestic and international laboratories that are either part of the Study Group (referred to as sites) or laboratories collaborating with the Study Groups (referred to as external research groups).

Preclinical Services for AIDS Therapeutics

Request for Proposals—proposed FY 2021 initiative

Contact: Patrick Finn

Objective: The initiative provides preclinical services/resources through an Indefinite Delivery, Indefinite Quantity (ID/IQ) contract. The following services will be solicited:

  • Reagent Program for HIV and Other Infectious Diseases
  • In Vitro Testing Resource
  • Chemical Synthesis Resource for Therapeutic Agents for Infectious Diseases
  • Small Animal Model Resources for HIV and Co-Infections [e.g., hepatitis B and C, tuberculosis (TB)]
  • Formulation Development and Clinical Manufacture of Dosage Forms
  • Preclinical Pharmacology and Toxicology Services

These services will support the discovery and development of therapeutic agents primarily for HIV infection and other infectious diseases (e.g., TB, hepatitis B and C). The goal is to facilitate rapid preclinical development of compounds and biologics towards regulatory submission and clinical trials.

Description: NIAID supports research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases.

NIAID supports contract resources and services to assist academic and small business investigators and facilitate preclinical drug discovery and development. These services have helped investigators identify therapeutic compounds, and obtain critical data and materials needed to attract additional funding, gain prospective partnerships, fulfill regulatory requirements, and complete preclinical studies needed before entering clinical trials.

The initiative is anticipated to result in a multiple-award ID/IQ contract across five fields described below, with awards to organizations that best meet the overall qualifications for fulfilling the technical requirements of each field. The ID/IQ mechanism provides the flexibility to support each of the fields according to need and program priority. The base ID/IQ contract will be for seven years with awards anticipated on or before May 30, 2021, to offerors capable of performing the work. The fields to be included are as follows:

  • Reagent Program for HIV and Other Infectious Diseases
  • In Vitro Testing Resource for HIV Therapeutics
  • Chemical Synthesis Resource for Therapeutic Agents for HIV and Other Infectious Diseases (e.g., hepatitis B and C, and TB)
  • Small Animal Model Resources for HIV, Hepatitis B and C, and TB
  • Formulation Development and Clinical Manufacture of Dosage Forms for HIV and Other Infectious Diseases (e.g., hepatitis B and C, and TB)
  • Preclinical Pharmacology and Toxicology Testing of Therapeutics for HIV and Other Infectious Diseases (e.g., hepatitis B and C, and TB)

NIAID anticipates that this task order-driven contract will have the flexibility to support each field according to the need. Each project will be thoroughly reviewed, carefully prioritized, and selected by the DAIDS Preclinical Therapeutics Development Committee, and approved before initiating a task order request.

The contract will allow NIAID to provide specific support of drug discovery and product development for next-generation therapies to meet the evolving needs of the Division of AIDS’ Basic Sciences Program and Therapeutics Research Program for the following services:

The Reagent Program for HIV and Other Infectious Diseases

  • Acquire, store, and maintain an inventory of biological and chemical research materials for HIV and other infectious diseases
  • Provide a system to allow researchers to order and receive HIV and other infectious disease reagents at no cost through a web portal
  • Develop and implement authentication, characterization, and internal quality assurance/quality control programs to ensure quality of materials

In Vitro Testing Resource for HIV Therapeutics

Drug discovery and lead development tools to

  • Develop assays and models that are physiologically relevant for inhibiting HIV replication
  • Conduct in vitro evaluation of potential therapeutics for efficacy, toxicity, and safety pharmacology in cell-based and specialized cell- or target-based assays
  • Adapt selected assays to a high-throughput format and perform high-throughput screening of chemical compound libraries
  • Perform hit-to-lead progression studies on promising compounds
  • Conduct mechanism of action studies on lead compounds

Chemical Synthesis Resource for Therapeutic Agents for Infectious Diseases (e.g., HIV, hepatitis B and C, and TB)

Synthesis of therapeutic agents in small- and large-scale amounts. Compliance with current FDA Good Manufacturing Practice (GMP) will be required in some cases. Synthesis scale will vary with quantities needed for testing in either in vitro screens, animals, or early Phase I clinical studies.

Small Animal Model Resources for HIV, Hepatitis B and C, and TB

Evaluate the efficacy of potential interventions (therapeutics, cure strategies, pre-exposure prophylaxis) in small animal models of HIV, hepatitis B and C, and TB. Proof of efficacy in an animal model is now recognized as an important complement to traditional in vitro activity assessments for product development.

The animal models envisioned will include:

  • Immunodeficient mice engrafted with human tissues of fetal or non-fetal origin that can be infected with well-characterized clinical isolates of HIV-1, hepatitis B virus, and hepatitis C virus, and support both systemic and mucosal routes of infection
  • Conventional small animal models for TB and hepatitis
  • Newly developed small animal models

Formulation Development and Clinical Manufacture of Dosage Forms for Infectious Diseases (e.g., HIV hepatitis B and C, and TB)

  • Development of new formulations and dosage form manufacture
  • Activities of packaging, labeling, and shipping products intended for evaluation in clinical trials [compliant with applicable good laboratory practice (GLP) or GMP regulations]
  • Development of analytical assays, with the capability to conduct studies compliant with the applicable GLP or GMP regulations
  • Targeted formulations to be developed include tablets, capsules, lyophilized powders, solutions, suspensions, aerosols, and nanomaterials for oral, intravenous, subcutaneous, intramuscular, or intranasal delivery

Preclinical Pharmacology and Toxicology Testing of Therapeutic Agents for Infectious Diseases (e.g., HIV, hepatitis B and C, and TB)

The contractor provides services suitable to facilitate regulatory submissions and intellectual property applications of third parties and to support decision-making by the investigator/sponsor and the FDA. The contractors will have the capacity to conduct GLP and non-GLP studies as appropriate. Services will include:

  • Preclinical development and investigational new drug-enabling animal studies of candidates to assess pharmacological properties; safety pharmacology; acute, repeated dose, and chronic toxicity; immunotoxicity; as well as genetic and reproductive toxicity
  • Bioanalytical method development and bioanalytical testing to support the studies described above
  • In vitro assays used in preclinical development, such as mitochondrial toxicity screening in 3-dimensional culture, hollow-fiber cell culture, liquid culture systems, or organ-on-a-chip technology
  • Potential therapeutic agents may include small molecules, polymers, biologics (e.g., peptides, oligonucleotides, antibodies), cellular and genetic drug products (e.g., CAR-T cells), or products with nanomaterials in their finished dosage form

Immunology Quality Assessment (IQA) Program

Request for Proposals—proposed FY 2021 initiative

Contact: Christopher Weaver

Objective: This initiative will continue to provide a critically needed resource to support NIAID clinical studies on preventing and treating HIV/AIDS and its infectious and non-infectious co-morbidities, domestically and internationally. Specifically:

  • Monitor the ability of laboratories (labs) supporting DAIDS clinical trial networks, NIAID Study Groups, and collaborating domestic and international investigators to accurately and reliably perform study-specified immunological tests (e.g., CD4 and CD8 enumeration performed in non-U.S. labs) and to reliably freeze viable peripheral blood mononuclear cells (PBMCs) and process leukopaks needed for immunological and virologic tests. Advise and train when deficiencies are identified.
  • Facilitate optimizing, standardizing, and validating immunological assay methodologies, with focus on laboratory-developed-tests (LDTs), and their implementation in NIAID-supported studies.
  • Help labs that perform PBMC viable freezing and/or immunological LDTs meet sponsor and regulatory requirements for good clinical laboratory practices (GCLP).
  • Provide options to increase services and/or increase the number of laboratories to be supported by the contract.

Description: The IQA contract will support a range of activities, which may include:

  1. Providing guidance and support to labs for performing assay characterization of study-specified LDTs (e.g., sTNFR2, quantitative HBV serology, CD137) that may be included in a regulatory submission in support of product licensure. As needed, the IQA will provide labs with quality control materials (e.g., spiked plasma, donor biological materials) and create new proficiency testing schemes, in coordination with the EQAPOL contract, for monitoring the quality of such testing.
  2. Obtaining or preparing proficiency testing (PT) panels of coded samples to be shipped to >40 non-U.S. CD4 labs in approximately 15 countries, receiving test results from labs, analyzing and grading performance, issuing performance reports, and guiding labs in investigating root causes of poor performance to correct and prevent future deficiencies.
  3. Monitoring the ability of >50 U.S. and >40 non-U.S. PBMC freezing labs in 15 countries, as well as monitoring the ability of >15 labs to reliably process leukopaks and freeze large numbers of PBMC-containing tubes. Frozen samples will be shipped from labs to the IQA for thawing and determining cell viability and viable yields. The IQA will analyze and grade performance, issue reports and provide labs with guidance to correct and prevent future poor performance.
  4. Conducting at the IQA, or facilitating multi-lab, studies to compare, optimize, and standardize immunological assay methodologies, for eventual implementation in NIAID-supported studies.
  5. Providing support to PBMC freezing labs and to specialized immunology labs for conducting laboratory operations according to GCLP. This will include review of GCLP lab audit reports (audit done by another contractor), capturing audit findings and providing guidance to labs in resolving deficiencies.
  6. Maintaining a 508- and FISMA-compliant web-based information repository that includes lab-specific documents such as records of resolution of each lab's audit findings and performance in proficiency testing panels. The IQA will provide each participating laboratory with controlled access to its own documents and provide NIAID and other NIAID-designated entities with controlled access to all documents. The IQA will provide a public web-based resource library that includes guidance documents and standard operating procedures for various laboratory procedures.
  7. If necessary, enabling expansion of the program (through contract options) to provide support to additional labs and to support development and quality assurance of assays and methods related to emerging viral pathogens. This capacity will provide potential to serve other NIAID divisions.
  8. Providing options for in-house late stage assay development and validation, as well as testing of samples from NIAID-sponsored clinical trials, in a CLIA-certified laboratory.

Advancing Vaccine Science for Improving Tuberculosis (TB) Treatment Outcomes in HIV Infection

Request for Applications—proposed FY 2021 initiative

Contact: Daniel Frank

Objective: The purpose of this funding opportunity announcement (FOA) is to invite applications for innovative clinical and preclinical/translational research to develop therapeutic vaccine strategies to improve outcomes of active TB disease in the presence or absence of HIV co-infection.

Description: The goal of this FOA is to encourage innovative studies focused on:

  1. Correlating changes in host immune cell regulation and functions associated with Mycobacterium tuberculosis (Mtb) proliferation versus control during active infection and/or clinical recurrence
  2. Evaluating the impact of Mtb strain variation and host genetic/epigenetic factors on immune responses to candidate therapeutic vaccines and adjuvants and modulation of disease outcomes, i.e., decreasing recurrence (relapse/re-infection) and/or treatment shortening
  3. Assessing the effects of candidate TB vaccines and adjuvants combined with TB antimicrobial therapy [and HIV antiretroviral therapy (ART), as appropriate] for drug sensitive and drug resistant TB on treatment outcomes

Research topics of interest in advancing therapeutic vaccine science for improving TB treatment outcomes in the presence or absence of HIV include but are not limited to:

  • Identifying mechanisms of immune alterations during active disease and in relapse settings with focus on enhancing effective immunity and/or restricting immune suppression
    • Changes in regulatory pathways, immunometabolism, gene expression, and epigenetics as targets for therapeutic vaccine/adjuvant design
    • Microbial factors involved in immune-suppressive responses
  • Evaluating current and novel candidate TB vaccines/adjuvants with antimicrobial chemotherapy (including for drug-sensitive/multi-drug resistant TB and, as appropriate, HIV ART) for decreasing recurrence and/or treatment shortening strategies
    • Rational choices of vaccines with adjuvants/host-directed therapy agents to enhance or restrict specific immune responses and improve therapeutic outcomes
    • Assess the impact of vaccination timing during and/or after TB therapy
    • Assess effects of therapeutic vaccination for potential changes in tissue damage
  • Identify correlates of protection from TB recurrence and potentially a biosignature for protection status

Studies with appropriate animal models and human cells and tissues are encouraged and may include samples from both HIV-infected and uninfected individuals. Animal model adaption/improvement and development of novel functional assays for correlating changes in immune functions with treatment effects is encouraged but cannot be a primary focus of the application. Highly collaborative multidisciplinary research teams incorporating expertise in infectious diseases, vaccinology, and immunology and using novel research tools to probe molecular targets and alterations in specific host defense mechanisms triggered by TB disease and vaccines/adjuvants are strongly encouraged.

Applications evaluating alterations in host environment with a primary focus on analyzing cytokines, chemokines, eicosanoids, and immune cell subset enumeration without a focus on understanding fundamental immune cell mechanisms associated with enhanced antimicrobial restriction, treatment shortening, or protection against recurrence will not be supported. Applications which propose clinical trials or establishing patient cohorts will not be supported.

Innovation for HIV Vaccine Discovery

Program Announcement With Special Receipt, Referral, and/or Review Considerations—proposed FY 2021 initiative

Contact: Jon Warren

Objective: The objective of this initiative is to stimulate research on novel, high-risk/high-impact early discovery vaccine research that may have significant impact on the design and development of immunogens or immunization strategies for an effective HIV vaccine.

Description: Specifically, this initiative will support areas of basic vaccine discovery research that have not been fully explored or exploited that may lead to identifying new target molecules or approaches that help design an effective HIV vaccine. Examples of responsive research include but are not limited to:

  • Novel approaches to elicit durable cellular responses and/or broadly neutralizing protective antibodies against HIV and/or SIV
  • Novel approaches to direct protective adaptive and/or innate immune responses to relevant mucosal or systemic sites
  • Exploring the utility of synthetic vectors for immunogen delivery
  • Developing new animal models, vectors, assays, and adjuvant and/or vaccine formulations but only if specifically linked to a novel vaccine intervention strategy for preventing acquisition or clearance of virus-infected cells; evaluating proposed hypotheses with appropriate animal models (e.g., with nonhuman primate or humanized mice models) is encouraged
  • Using clinical specimens to answer key questions about systemic and/or mucosal immune responses to HIV infection in humans that could lead to vaccine improvements
  • The potential of host or non-host (e.g., allogeneic) proteins to act as immunogens alone or together with HIV/SIV immunogens
  • Previously unexplored HIV-/SIV-encoded targets as immunogens
  • Vaccine induced/imprinted innate immune responses that can be recalled in response to subsequent vaccination or infection
  • Functional genomics approaches to dissect effective adaptive and/or innate mucosal/systemic immune responses to vaccines

To ensure that innovative applications are evaluated on their ideas, the program announcement will state that the absence of preliminary data in the application should not negatively impact the score. Applications will be required to include “Go/No-Go" criteria, to be achieved by the Year 2 Progress Report, thus allowing Program to effectively manage the high risk associated with "innovation" research.

The principal criterion for ending this program would be the discovery and implementation of an effective HIV vaccine.

Myeloid-Derived Suppressor Cells (MDSCs) as Potential Therapeutic Targets in TB/HIV

For the published program announcements with special receipt, referral, and/or review considerations, see the September 3, 2019 Guide announcements:

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