June 2018 DMID Council-Approved Concepts (NIAID-NIH)

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.

Franco-Thai Mobility Programme 2019-2020 - Deadline 23 July

Funding Opportunity Purpose

This is a two year programme to develop research cooperation between France and Thailand, and is supported by Thailand's Office of Higher Education, the Thailand Research Fund, National Science and Technology Development Agency/NSTDA, the French Ministry of Foreign Affairs, and the French Ministry of Higher Education, Research and Innovation.

The programme can fund projects in a number of domains including the social sciences, culture and tourism; math, engineering and chemistry, big data, nanotechnolgy, biotechnology, health, energy, environment, and agriculture.

Objective:
To develop joint projects in research and/or research training. To encourage exchanges between French and Thai higher education institutions and research bodies, and to develop sustainable collaborative research activities.

Area (Health Science)

• Re-emerging and Infectious Diseases
• Biotechnology, Natural Substances (Pharmacology, Traditional Drugs)
• Neurosciences
• Medical Science
• Genomics
• Proteomics
• Metabolomics
• Bioinformatics
• Big Data Management

Activity
Proposed project should focus on implementation of joint research activity, and junior researchers (master’s, doctoral and post-doctoral students) training, taking into consideration the development of:

• promising Thai and French partnership
• scientific and technological research in the priority fields listed above,
• research capacity building,
• valorisation and knowledge transfer.

Projects implementation will be based on the following main operations: exchange of senior and junior researchers, the training periods in research laboratories, seminars and scientific meetings, workshops, etc. 

Eligibility

• Each proposal should be jointly submitted by network formed one partner at least in France and one partner at least in Thailand.
• The projects which have been already supported by the Franco-Thai PHC Programme will not be eligible.
• Researchers are strongly encouraged to generate continuity of the project after having been supported by the Franco-Thai PHC Programme, constantly carrying on the project with a future perspective.

Award Budget
Project should be co-financed by partner institutions.
French Ministry for Europe and Foreign Affairs will support expenses with the maximum of 12,000 Euros per year for each project. 

Award Project Period
Each project will take 2 years for implementation. 
  
Deadline

Application Due Date July 23, 2018.

Full details: https://euraxess.ec.europa.eu/worldwide/asean/franco-thai-mobility-programme-2019-2020-call-now-open-deadline-23-july

Call for Proposal: http://inter.mua.go.th/2018/04/franco-thai-mobility-programme-call-for-proposals-2019-2020/#.WyHht1UzbAX

Proposal Guide: http://inter.mua.go.th/wp-content/uploads/2018/04/Info-Call-for-proposals-2019-2020.pdf

Approaches for Understanding Disease Mechanisms and Improving Outcomes in TB Meningitis (NIH)

Funding Opportunity Announcement (FOA) Number: PAR-18-822

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to invite applications for support of innovative clinical and preclinical/non-clinical research to improve our understanding of disease mechanisms in tuberculosis meningitis (TBM) and to improve therapy in the presence or absence of human immunodeficiency virus (HIV) co-infection.

Research Objectives and Scope

This FOA will support hypothesis-based clinical and preclinical/non-clinical research studies focused on: 1) Identifying pathogenic and immunopathogenic mechanisms in the context of CNS-TB in in vitro and appropriate animal models that impact TBM disease development, progression, and outcomes, as well as the effect of HIV co-infection on these mechanisms; 2) Assessing molecular targets in pathogenic and immunopathogenic mechanisms leading to discovery or confirmation of targets for HDT; and 3) Evaluating new/repurposed antimicrobial drugs and/or dosing of current antimicrobials that are optimized for TBM treatment for use in combinations to more rapidly clear the infection.

Research topics of interest on TBM pathogenesis and treatment in the presence or absence of HIV include, but are not limited to:

• Mechanisms of Mtb dissemination into the CNS including:
• Role of antigen-presenting cells, e.g., dendritic cells, and vascular endothelial cells
• Microbial factors involved in CNS penetration, localization and dissemination
• Role of microglia and other CNS-specific immune cells responding to/or infected by Mtb and HIV, and mechanisms for persistence and subsequent reactivation
• Mechanisms and mediators of dysregulation of signaling pathways of CNS immune cell responses involved in TBM pathogenesis with and without HIV infection, including evasion of host defenses and vascular and CNS cell damage
• Role of innate immune cell receptors (e.g., pattern-recognition receptors) in the cellular stress/damage mechanisms of TBM and CNS IRIS
• Determining promising targets for adjunctive TBM HDT, and testing specifically targeted host-directed agents in appropriate models
• Identification of candidates for improved diagnostics, indicators of disease severity, and prognostic biomarkers for treatment outcomes derived from immunopathogenic studies in animal models, and validation utilizing stored clinical samples
• Developing and testing antimicrobial drug regimens in appropriate TBM models, including new and repurposed agents and/ or optimized dosing of current anti-TB drugs

Highly collaborative multidisciplinary research teams incorporating expertise in infectious disease, neurology, and immunology, and making use of novel research tools to probe mechanisms of CNS immune pathology, key microbial virulence factors and alterations in host defenses caused by Mtb infection (with and without HIV co-infection) are strongly encouraged.

The following types of applications will not be supported through this FOA:

• Applications which propose clinical trials or the establishment of patient cohorts.
• Applications which focus solely on HIV.
• Applications primarily focused on cytokines/interleukins, chemokines, interferons, or eicosanoids as targets.

See Section VIII. Other Information for award authorities and regulations.

Eligibility

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Award Budget
Application budgets are not limited but need to reflect the actual needs of the proposed project.

Award Project Period
The scope of the proposed project should determine the project period. The maximum project period is 5 years.  

Key Dates

Open Date (Earliest Submission Date): August 4, 2018.

Letter of Intent Due Date(s): Not Applicable

*Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Scientific Merit Review: October 2018

Advisory Council Review: January 2019

Earliest Start Date: April 2019

Deadline

Application Due Date(s)

September 4, 2018 by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates.

Full details: https://grants.nih.gov/grants/guide/pa-files/PAR-18-822.html

Fogarty Emerging Global Leader Award (NIH)

Announcement(s)

• Emerging Global Leader Award (K43) (PAR-17-001), reissued October 4, 2016
• Optional: Apply using NIH ASSIST (NOT-OD-15-126)
• Career Award (K) Policy Update: Concurrent Support from a Mentored K Award and a Research Grant (NOT-OD-18-157), released April 6, 2018

Deadlines

• Letter of Intent due dates: 30 days before the application due date​
• Upcoming application due date: November 7, 2018
• Related notice: Notice of Change in Key Dates for PAR-17-001 Emerging Global Leader Award (K43), released February 8, 2018

Eligibility

• Some current and former NIH PDs/PIs are not eligible, as specified in the May 31, 2017 notice of change in eligibility (NOT-TW-17-004).
• Notice of change in eligibility (NOT-TW-18-002), released November 8, 2017
• Only low- or middle-income country (LMIC) institutions are eligible.
• Income categories are defined by The World Bank Country and Lending Groups .
• Country eligibility for Fogarty International Training Grants applies.
• Candidates must be LMIC citizens.
• Candidates must hold an academic junior faculty position or research scientist appointment at the LMIC applicant institution and must have been in this position for at least one year at the time the application is submitted.
• Candidates are required to have both U.S. and LMIC primary mentors.
• Research should take place primarily in the LMIC.
• Individuals who have already received independent research funding are not eligible.
• Applicants should demonstrate that they are committed to an independent research career and justify the need for three to five years of mentored research experience in order to become an independent research scientist.
• View full eligibility details in the program announcement and refer to FAQs.

Program Overview

The Fogarty Emerging Global Leader Award aims to provide research support and protected time to a research scientist from a LMIC who holds an academic junior faculty position or research scientist appointment at an LMIC academic or research institution. Low-income, lower-middle-income and upper-middle-income countries are included.

Applications are invited from LMIC research scientists from any health-related discipline who propose both critically needed career development activities and a research project that is highly relevant to the health priorities of their country.

Recent Awards

View a list of Emerging Global Leader awards by institution.

Frequently Asked Questions

​Access answers to frequently asked questions (FAQs) about the Fogarty Emerging Global Leader Award.

Inquiries

​Programmatic Inquiries:

Christine Jessup, Ph.D.
Program Officer
Fogarty International Center
National Institutes of Health
Building 31, B2C39
31 Center Drive MSC 2220
Bethesda, MD 20892-2220
Phone: 301-496-1653
Fax: 301-402-0779
Email (preferred): Christine.Jessup@nih.gov

Grants Management:

Mollie Shea
Grants Management Specialist
Fogarty International Center
National Institutes of Health
Building 31, Room B2C29
31 Center Drive, MSC 2220
Bethesda, MD 20892-2220
Telephone: 301-496-9750
Fax: 301-594-1211
Email: Mollie.Shea@nih.gov

Award Budget

Award budgets are composed of salary and other program-related expenses, as described below. NIH will contribute up to $75,000 (for a minimum of 75% effort or 9 person months) per year toward the salary of the career award recipient. NIH will contribute up to $ 30,000 per year toward the research development costs of the award recipient, which must be justified and consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities.

Award Project Period

The total project period should be a minimum of 3 years and may not exceed 5 years.

*Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Scientific Merit Review: March 2019

Advisory Council Review: May 2019

Earliest Start Date: July 2019

Deadline

Application Due Date(s)

November 7, 2018 by 5:00 PM local time of applicant organization.  All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

Full details: https://grants.nih.gov/grants/guide/pa-files/PAR-17-001.html