Concepts represent early planning stages for program announcements, requests for applications, or solicitations for Council's input.
Council approval does not guarantee that a concept will become an initiative.
Collaborative Influenza Vaccine Innovation Centers (CIVIC)
Broad Agency Announcement—proposed FY 2019 initiative
Contact: Teresa Hauguel
Objective: To support a new consortium focused on developing innovative influenza vaccines that provide robust, durable, broadly protective immunity (universal influenza vaccines) and improve the immunogenicity and durability of licensed seasonal influenza vaccines.
Description: This initiative will support a coordinated, multidisciplinary effort to improve influenza vaccine using rational, iterative, immunology-based design and testing, and advance the most promising vaccine candidates to Phase I/II clinical trials.
This initiative will support preclinical and clinical research to:
Rationally design and evaluate influenza vaccine immunogens, antigen/adjuvant combinations, and delivery platforms
Conduct comprehensive immunological analyses to support the design and testing of influenza vaccine candidates
Test novel combinations of vaccine approaches and conduct head-to-head comparisons to down-select and identify the most promising influenza vaccine candidates for further development
Design, develop, qualify, and validate protocols, reagents, and assays for preclinical and clinical characterization and evaluation of influenza vaccine immunogenicity and efficacy
Optimize, formulate, and manufacture influenza vaccines and vaccine components
Conduct investigational new drug-enabling safety and toxicity testing of influenza vaccines and vaccine components
Design, implement, and manage clinical trials and human challenge studies for the most promising influenza vaccine approaches
Leadership Group for an Infectious Diseases Clinical Research Consortium
Request for Applications—proposed FY 2020 initiative
Contact: Seema Nayak
Objective: To support planning and implementing clinical trials and studies that address the scientific priorities of NIAID in evaluating vaccines, biologics, therapeutics, diagnostics, biomarkers, and devices for infectious diseases.
Description: This initiative will support a leadership group (LG) to plan and implement clinical trials to prevent and treat infectious diseases. The interventional trials will primarily be tested in healthy outpatient populations or in patients in clinic settings that routinely treat infections not requiring hospitalization. The LG will be responsible for overseeing protocol development, statistical design, budgeting site costs (per participant), and site selection, allowing for integrated and efficient operational and fiscal management of the clinical trials. The LG will convene expert working groups in specific areas of scientific expertise (e.g., respiratory pathogens, enteric pathogens, malaria/tropical diseases, sexually transmitted infections, pharmacology) to review concepts for clinical trials, prioritize concepts, and plan for trial implementation. The working groups will include Vaccine and Treatment Evaluation Unit (VTEU) investigators as well as other experts in the fields of interest. Together with NIAID, the LG will plan, coordinate and oversee clinical trials conducted through VTEUs or other NIAID-supported clinical sites. This infrastructure should foster collaborative approaches to addressing NIAID priorities and provide a more streamlined mechanism for NIAID to evaluate and advance the development of vaccines, therapeutics, biologics, diagnostics, and other products.
Vaccine and Treatment Evaluation Units (VTEUs)
Request for Applications—proposed FY 2020 initiative
Contact: Seema Nayak
Objective: To support clinical trial sites for evaluating vaccines, biologics, therapeutics, diagnostics, biomarkers, and devices for infectious diseases.
Description: This initiative will support multiple sites capable of conducting clinical trials and other types of clinical research for vaccines and other biologics, therapeutics, diagnostics, and devices targeting infectious diseases. Clinical trial concepts implemented by the VTEUs may arise from the research community or from NIAID staff and may include products from DMID’s preclinical and early product development programs. Under a separate initiative, a leadership group will be awarded that will plan, implement, and oversee the clinical trials that will be implemented at VTEU sites, including protocol development, per-participant protocol costing, and site selection. Together the interaction of the leadership group, principal investigators of the VTEUs, and DMID staff will form an integrated consortium to plan and conduct NIAID-supported clinical studies.
Each VTEU will contain one or more sites to implement clinical trials, including sites that may have the ability to enroll unique populations (such as children or the elderly). Sites will need to have demonstrated ability to efficiently recruit normal healthy volunteers. Additional capabilities of interest include the ability to recruit patients with common outpatient infections such as sexually transmitted infections or respiratory viral infections; ability to conduct controlled human infection model (challenge) studies; and ability to conduct Phase 1 first-in-human pharmacologic studies. Together, the VTEUs will implement clinical trials in populations that span ages and will allow for expedited clinical development of candidate products. This includes Phase 1 evaluation of vaccines and therapeutics in healthy volunteers and Phase 2 initial efficacy evaluation of therapeutics and vaccines in patients for which the treatment would be indicated. Importantly, the VTEUs will provide capable sites that are ready to conduct studies important to the public health that the private sector might not have incentive or resources to conduct, including pre-pandemic influenza vaccines manufactured by BARDA/DHHS for stockpiling and first-in-human studies of new antibiotics. Additionally, the VTEUs could be a mechanism to conduct studies of biologic countermeasures during a public health emergency.
Leadership Group for a Clinical Research Network on Antibacterial Resistance
Request for Applications—proposed FY 2020 initiative
Contact: Jane Knisely
Objective: To support a Clinical Research Network on Antibacterial Resistance (AR), which will design, prioritize, implement, and manage a clinical research program to address key clinical research questions in AR.
Description: This initiative will renew support for a Clinical Research Network on AR to address critical clinical research questions. The program will include several components, including a scientific leadership center, an operations center, a laboratory center, and a statistics and data management center. The scientific leadership group will be responsible for the network’s overarching research agenda to address AR and a clinical operations center will be responsible for selecting and managing protocol-specific sites. General areas of clinical research could include:
Early clinical evaluation of new antibacterial therapeutic and prophylactic products, including small molecule antibiotics, monoclonal antibodies, applications of microbial ecology approaches, bacteriophage-based products, and vaccines
Comparative effectiveness trials
Strategy trials to optimize currently licensed antibacterials (e.g., dose, duration, clinical algorithms, need for drug, combinations) to reduce the risk of resistance
Validation studies of new diagnostic tests using clinical isolates or specimens, including to support regulatory submissions
Clinical utility studies of diagnostic tests to determine the impact of approved tests on patient- and facilities-level outcomes and prescribing behavior
Molecular epidemiological studies to provide data on the associations between patient characteristics, clinical outcomes, and resistant genotypes/phenotypes, and to inform future interventional trials
Pharmacokinetic and pharmacodynamic studies
Strategies to better manage the consequences of broad spectrum antimicrobial use, e.g., Clostridium difficile infections
Collaborations with industry and academic groups as needed, both domestically and internationally, to guide optimal clinical trial designs, answer key questions that cannot be addressed alone, and strengthen a community of AR researchers that can contribute to the U.S. government’s response to emerging resistant threats
Accelerating Malaria Vaccine Discovery
Program Announcement—proposed FY 2020 initiative
Contact: Annie Mo
Objective: To generate new antigens and/or vaccine candidates against malaria suitable for further downstream development and clinical evaluation.
Description: The overall goal of this initiative is to encourage and stimulate early-phase translational research to accelerate the discovery of malaria vaccine candidates, including those targeting three different life cycle stages (i.e., pre-erythrocytic stage, blood stage, and/or sexual stage) of the parasites that cause human malaria, especially Plasmodium falciparum and P. vivax.
The initiative will support identifying, characterizing, credentialing, and validating new protective* antigens or vaccine candidates with appropriate assay systems or animal models, including:
Discovering novel protective antigens/peptides through genomics, proteomics, immunomics, or other ‘omics approaches
Identifying, characterizing, credentialing, or validating new protective epitopes
Discovering new vaccines using novel technology platforms with either new or already known malaria antigens
Structure-based vaccine design and testing
Credentialing and validating new vaccine candidates with novel assays or animal models
In addition, this initiative will support design, construction, screening, and in vitro or in vivo preclinical testing of attenuated whole organism antimalarial vaccines, especially late liver stage-arresting whole sporozoite vaccines using genetic manipulation of Plasmodium parasites.
*Note: “Protective” refers to appropriate functional characteristics, such as preventing infection, ameliorating disease, interrupting transmission, or prohibiting relapse, when applicable.
Advancing Research Needed To Develop a Universal Influenza Vaccine
Program Announcement—proposed FY 2019 initiative
Contact: Diane Post
Objective: To support research activities that will advance the areas of interest outlined in A Universal Influenza Vaccine: The Strategic Plan for the National Institute of Allergy and Infectious Diseases (link is external), including efforts to 1) improve understanding of transmission, natural history, and pathogenesis of influenza virus infection, 2) characterize influenza immunity and correlates of immune protection, and 3) support rational design of universal influenza vaccines.
Description: This funding opportunity announcement will support research to advance the objectives defined in A Universal Influenza Vaccine: The Strategic Plan for the National Institute of Allergy and Infectious Diseases. (link is external) Specific areas of research interest include, but are not limited to:
Improve understanding of transmission, natural history, and pathogenesis of influenza virus infection
Characterize influenza immunity and correlates of immune protection
Support rational design of universal influenza vaccines
Improve understanding of influenza transmission, natural history, and pathogenesis
Expand understanding of influenza transmission, including the role of climate and geography, host factors, physical and environmental factors, and identify targets for improving interventions for disease control
Determine the role of anti-hemagglutinin stem and anti-neuraminidase antibodies in preventing transmission
Identify viral and host factors associated with transmission and the severity of influenza
Identify immune markers associated with reduced disease severity
Determine the role of bacterial or viral co-infections with the severity of influenza disease
Precisely characterize circulating influenza viruses
Develop and test models predicting the influence of pre-existing immunity on virus evolution to anticipate the next emerging dominant seasonal influenza strain
Improve genotypic and phenotypic characterization of circulating viruses associated with adverse clinical outcomes, host immunity, and vaccine failures
Identify/characterize immune responses required for protection:
Improve understanding of how and when exposure to influenza antigens shapes the subsequent immune response to influenza virus infection and vaccination
Characterize immune responses in those with a limited hemagglutination inhibition (HAI) response to infection or to vaccination
Determine the interaction of innate and adaptive immunity in the response to influenza infection or vaccination
Define the mechanism of broadly protective humoral immunity against influenza, including processes that affect antigenic immunodominance
Elucidate mechanisms of protective immunity versus those that ameliorate symptomatic disease
Assess tissue-resident (e.g., airway) influenza-specific T cell immunity; compare with circulating influenza-specific T cell responses
Elucidate antibody responses to hemagglutinin and neuraminidase and their contribution to immune protection
Identify alternative mechanisms of antibody-dependent protection beyond virus neutralization/HAI function
Support rationale design of universal influenza vaccines:
Design new immunogens that elicit broad protection
Advance new vaccine approaches into preclinical models that exploit emerging antigen design strategies, novel technologies, and/or platforms
Define mechanisms and correlates of vaccine-induced protection
Identify vaccine candidate(s) that provide broad protection, superior to the seasonal influenza vaccine, and advance candidates to next phase of testing
Test adjuvants and alternative delivery methods to enhance breadth and durability of immunity
Develop and use systems biology approaches to analyze diverse and multi-scale influenza infection and vaccination data sets
Develop/improve animal models and reagents to advance vaccine development
Control of Sexually Transmitted Infections (STIs) Through a Comprehensive Understanding of the Natural History of Infection
Program Announcement—proposed FY 2020 initiative
Contact: Carolyn Deal
Objective: To encourage research to advance the understanding of natural history of infection for three STIs: gonorrhea, syphilis, and chlamydia.
Description: Under this initiative, investigators may propose studies that will result in new and improved approaches to understanding the natural history of gonorrhea, syphilis, and chlamydial infections. Any area of basic, translational, clinical research, or epidemiological research may be proposed under this program (no clinical trials). Examples of possible research topics include, but are not restricted to studies to better define:
Host response to infection
Correlates of protection
Clinical endpoints of disease
Biological and clinical factors that influence clearance rather than persistence of infection
Research To Advance Vaccine Safety
Program Announcement—proposed FY 2019 initiative
Contact: Barbara Mulach
Objective: This program encourages research that will contribute to the overall understanding of scientific factors and issues related to vaccine safety.
Description: The purpose of this funding opportunity announcement (FOA) is to support research that will contribute to the overall understanding of vaccine safety. This research opportunity encourages studies that address scientific areas potentially relevant to vaccine safety such as 1) physiological and immunological responses to vaccines and vaccine components, including different adjuvants, 2) how genetic variations affect immune/physiological responses that may impact vaccine safety, 3) identifying risk factors (e.g., infection history, predisposition to or presence of allergic or autoimmune disease) and biological markers that may be used to assess whether there is a relationship between certain diseases or disorders and licensed vaccines, 4) creating/evaluating statistical methodologies for analyzing data on vaccine safety, including data available from existing data sources such as passive reporting systems or healthcare databases, or 5) applying genomic/molecular technologies and systems biology approaches to evaluate vaccine safety. This FOA aligns with the research goals and objectives outlined in the U.S. National Vaccine Plan.
Secondary Analysis of Existing Datasets for Advancing Infectious Disease Research
Program Announcement—proposed FY 2020 initiative
Contact: Ishwar Chandramouliswaran
Objective: To support secondary analyses of existing datasets in the NIAID Bioinformatics Research Centers (BRCs) to address scientific questions relevant to infectious diseases.
Description: This initiative will support small-scale projects that use existing datasets in public data repositories generated by NIAID-funded research projects (alone or in combination with other datasets) to address knowledge gaps in basic and clinical infectious diseases. Applications submitted in response to this program announcement must use data deposited in the NIAID Bioinformatics Research Centers but may combine these datasets with data from other sources, either public or private.
TropMed Sponsored Research Funding Opportunities: this blog is designed to alert TropMed researchers to funding opportunities to support their research. The Research Administration Unit of the Office of Research Services (ORS) is here to help staff members with all application, grant management, and post-grant processes. Please contact Mr. Paul Adams or Mr. Oiko Tacusalme on ext. 1332 for more information, or to express interest in any of these grant opportunities.
