NB: Concepts represent early planning stages for PAs, RFAs, or RFPs for Council 's input. Council approval does not guarantee that a concept will become an initiative.
If NIAID publishes an initiative from one of these concepts, we link to it below. For a full list of initiatives, go to NIH Funding Opportunities Relevant to NIAID.
Table of Contents
Dissecting the Immune Response to HIV
Request for Applications
Contact: Alan Embry
Phone: 301-435-3751
Email: aembry@niaid.nih.gov
Objective: To apply a systems biology approach to better understand complex interactions of HIV with the immune system.
Description: Activities will be carried out by multidisciplinary teams with HIV virology, immunology, genomics, proteomics, and bioinformatics expertise together with those of mathematics, imaging sciences, and computer sciences. Studies will employ a systems biology approach to understand complex interactions between HIV and the immune system. Projects will focus on one or more fundamental biological questions in HIV immunology and/or pathogenesis and will integrate experimental biology with computation and modeling.
Examples of projects that might be supported include: 1) the effects of CD4 T cell activation on B cell function (and vice versa) and on HIV replication; 2) the effects of stimulation of the innate immune system on CD4 T cell activation and HIV replication (including humanized mouse models); 3) the effects of immune suppression/modulation on HIV replication (explant tissue models); and 4) the effects of high (or low) viral load/proteins in plasma on individual cell populations.
In Vivo Imaging
Program Announcement
Contact: Opendra Sharma
Phone: 301-496-9041
Email: osharma@niaid.nih.gov
Objective: To promote collaboration among multidisciplinary teams of immunologists, virologists, and in vivo microscopists to conduct real-time visualization of the dynamic interaction between immune cells and HIV in humanized mice and human and primate tissue explants.
Description: This initiative will support aspects of basic HIV biology that have not been previously explored in vivo. Examples include:
- Dissemination of HIV in lymphatic tissue, including gut
- Migration and dynamics of HIV and immune cells after HIV exposure in the genital tract or rectum
- Interaction of immune mediators or inhibitors with mucosal tissues/cells in the context of infection or exposure to microbicides, therapeutics, and/or vaccines
- Determination of sub-clinical inflammatory responses in genital tissues → new safety technology
- Effectiveness of gene therapy, vaccines, and microbicides on HIV transmission and establishment of infection
Centers for AIDS Research (CFAR)
Program Announcement
Contact: Ann Namkung
Phone: 301-496-9176
Email: anamkung@niaid.nih.gov
Objective: To foster high quality AIDS research by increasing collaborations and multidisciplinary research within an institution, between institutions, and by enhancing translation of basic research findings into vaccine and therapeutic concepts in a synergistic and cost-effective manner.
Description: The program supports diverse core facilities (versus grant projects) to carry out AIDS research at institutions with a critical number of NIH-funded investigators who are performing high quality AIDS research. All CFAR programs include an administrative core and a developmental core and at least one clinical core and one basic core. The developmental core (D-CFAR) provides support for new investigators in AIDS research, pilot studies, evolving research opportunities, and high risk/high impact collaborative studies.
B-Cell Biology Network for HIV Vaccine Development
Request for Applications
Contact: Jeffrey Ahlers
Phone: 301-435-3756
Email: jahlers@niaid.nih.gov
Objective: To foster cross-fertilization between B cell immunologists and HIV vaccinologists that will inform vaccine design and immunization strategies for eliciting broadly reactive HIV-1 neutralizing antibody.
Description: This initiative will fund 3-4 research teams, comprising a network for HIV-1 vaccine development. Target areas will include: structure of HIV epitopes, antigen design, adjuvant optimization, mechanisms of viral neutralization, immunization strategies for eliciting neutralizing antibody responses, and B cell memory. Examples of research that might be funded through this mechanism include:
- Role of adjuvants, TLRs and immunomodulatory molecules in shaping the B cell response
- Role of T helper/Treg cells in antibody responses
- Determining methods for gaining insight into basic B cell immunobiology
- Design of immunogens with epitopes that can elicit broadly neutralizing antibodies
- Role of Baff/April and other ligands/receptors in selection and homeostasis
- Characterization of B cell subsets
- Role of DC in shaping B cell responses
Phased Innovation Awards
Program Announcement
Contact: Jon Warren
Phone: 301-402-0633
Email: jwarren@mail.nih.gov
Objective: To foster investigator-initiated AIDS vaccine research at the earliest stages of concept genesis and evaluation, placing a premium on high-risk, high-impact studies most likely to advance the field toward an efficacious AIDS vaccine.
Description: This initiative will support the development of:
- New/improved live and other vectors
- Immunogens that generate durable broadly neutralizing antibody to primary isolates
- New and optimized live virus challenge models in nonhuman primates
- Animal-to-human correlates and mechanisms of immune protection for both adaptive and innate responses
- New molecular adjuvants
- Ways to explore mechanisms of immunity in “controllers” of HIV/SIV
HIV Vaccine Research and Design
Program Announcement
Contact: James Bradac
Phone: 301-435-3754
Email: jbradac@niaid.nih.gov
Objective: To support projects that address important scientific questions relevant to AIDS prophylactic vaccine research and development.
Description: This program supports the following area of HIV/AIDS preclinical prophylactic vaccine research, including but not limited to:
- Correlates of immunity to HIV/AIDS or an appropriate virus/animal model system
- Approaches to increase immunogenicity of HIV antigens
- Development of improved viral and bacterial vector systems
- Development of improved animal model systems to address vaccine efficacy
- HIV structural studies as they relate to designing HIV immunogens
- Approaches to stimulate pertinent arms of the immune system as they relate to vaccine efficacy
Non-human Primate Core Immunology and Virology Laboratories
Request for Proposals
Contact: Eileen Webster-Cissel
Phone: 301-496-0349
Email: webstere@niaid.nih.gov
Objective: To ensure standardization and comparability of assays conducted for preclinical studies and to provide a common basis for assessment of the immunogenicity and efficacy of candidate HIV and SIV vaccines. The Nonhuman Primate Immunology and Virology Laboratories for AIDS Vaccine Research and Development, or NHP Core Laboratories, provide immunological and virological support for preclinical studies conducted at NIAID’s Simian Vaccine Evaluation Units (SVEUs) and conducted by AIDS vaccine researchers.
Description: The initiative will support three contracts. The scope, mechanism, and budgets will be similar to previous solicitations.
The Cellular Immunology Laboratory:
- Evaluation and characterization of cellular immune responses of nonhuman primates immunized with candidate HIV or SIV vaccines or infected with HIV, SHIV, or SIV by current assays: viral-specific ELISPOT, intracellular cytokine (ICS), flow cytometric analysis of phenotypic markers, viral-specific tetramer assays, and assessment of functional antiviral activity of cells from immunized nonhuman primates.
- Continued development of new assays as technology and knowledge evolves, particularly on the development of assays to detect immune responses in mucosal tissue and under GLP-like conditions to evaluate vaccines prior to use in human clinical studies.
The Humoral Immunology Laboratory:
- Assays to evaluate and characterize humoral immune responses of animals immunized with HIV or SIV vaccines or infected with HIV, SHIV, or SIV, with a focus on the development and conduct of assays to detect and assess antiviral neutralizing antibodies from immunized and infected animals.
- Continued development of panels of viruses for use as targets to assess ability of antibodies to neutralize a wide variety of viruses, with the objective of identifying vaccines capable of generating broadly neutralizing antibodies.
Quantitative Viral RNA Laboratory:
- Assays for quantitatively determining the level of SIV or SHIV viral RNA in plasma of nonhuman primates infected with SIV or SHIV. May include bDNA, NASBA, or PCR assays.
- Assays to detect and characterize viral RNA in mucosal tissues or secretions, lymphoid tissue, or other tissue from nonhuman primates infected with SHIV or SIV.
External Quality Assurance Program Oversight Laboratory
Request for Proposals
Contact: Eileen Webster-Cissel
Phone: 301-496-0349
Email: webstere@niaid.nih.gov
Objective: To establish a facility to develop, implement, and oversee external quality assurance (EQA) programs for immune monitoring assays, including vaccine vectors and novel diagnostic tests.
Description: This initiative will support development, performance, and oversight of EQA programs for the following tasks:
Quality assurance:
- Prepare and distribute proficiency panels and reagents to laboratories that conduct ELISpot assays and evaluate test results;
- Prepare and distribute a standard protocol with all materials and reagents to laboratories that perform intracellular cytokine staining and evaluate test results;
- Develop a proficiency panel for laboratories performing assays to detect pre-existing immunity to vaccine vectors;
- Develop a validation program for T cell functional assays such as proliferation/suppression/inhibition assays;
- Acquire and provide a proficiency panel to support assays for antibody function, subclass, and isotype determination;
- Acquire, establish, and characterize unique clade-specific virus panels as needed to help ensure assay quality and validity;
- Develop and operate a PBMC QA program that assesses the ability of laboratories to reliably process, freeze, store, and ship viable PBMCs.
Operations:
- Coordinate EQA activities within NIAID, HANC, GHAVE, and other partners;
- Acquire, isolate, characterize, produce, monitor, QA/QC, and distribute standard reagents, viruses, assay kits, and proficiency panels;
- Create and maintain a central web database for activities;
- Advise on assay validation, regulatory, compliance, and statistical issues;
- Optimize and validate assays and transfer technologies between laboratories.
Changes made in scope include additional types of EQA programs such as for PBMC specimens as well as additional immunology, vaccine vector, and virology assays.
Master Contract for Preclinical Prophylactic HIV Vaccine Development
Request for Proposals
Contact: Eileen Webster-Cissel
Phone: 301-496-0349
Email: webstere@niaid.nih.gov
Objective: To advance clinical research reagents and/or highly promising HIV prophylactic vaccine candidates into human clinical trials by supporting gap-filling activities through the contractor or its subcontracts.
Description: The primary contractor flexible subcontracting mechanisms:
- Prepare regulatory filings for pre-IND (type B) and IND submissions to the FDA
- Qualify manufacturers for cGMP capabilities (conduct GMP and/or GLP compliance audits)
- Manufacture cGMP products
- Conduct GLP preclinical toxicology and bio-distribution, integration studies
- Provide database support/development for non-human primate studies
- Provide database support/development for preclinical documentation (e.g. batch records, audit reports, etc.)
- Generate qualified reagents and validated assays needed for in-process testing or release of product
- Create a quality control unit specific for contract functions
- Provide capacity for GMP storage of vaccine products
The scope of this solicitation has been expanded relative to the current contract to include additional Quality Assurance/Control capabilities.
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