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US National Institutes of Health – Research to Advance Vaccine Safety (R01 Clinical Trial Not Allowed) – PA-18-873
Sponsor: US National Institutes of Health & Centers for Disease Control and Prevention 		Closing Date: 05-Feb-2019
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) characterization of 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) identification of risk factors e.g., infection history, predisposition to or presence of allergic and/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) creation/evaluation of 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) the application of 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.

Examples of research topics of interest include, but are not limited to:
• Detailed evaluation of various host immune/physiological responses to currently licensed vaccine antigens and/or adjuvant combinations.
• Studies to elucidate biological mechanisms contributing to adverse effects following immunization (AEFI), including host genetic variations that may be associated with susceptibility to an AEFI.
• Studies that utilize novel animal models, such as the Collaborative Cross or Diversity Outbred mouse strains, to identify genetic markers associated with AEFI.
• Identification of the molecular basis for differential immune/physiologic responses to vaccination at different stages of life, including early life, during pregnancy, or in old age; or when underlying health problems, including immune-mediated diseases and immune deficits (induced or naturally occurring) exist.
• Identification of risk factors, such as prior infection history, predisposition to or in the presence of underlying immune-mediated disease, and biological markers that would allow for assessment of whether there is a relationship between certain diseases or disorders and licensed vaccines.
• Systems biology approaches to investigate the potential interaction networks of genes, proteins and other human cellular molecules in response to vaccines, to evaluate vaccine safety.
• Creation/evaluation of statistical methodologies to provide rigorous analysis of vaccine safety data from existing sources, including computerized healthcare databases (e.g., Vaccine Safety Datalink) and passive reporting systems (e.g., Vaccine Adverse Events Reporting System), to establish novel approaches to designing studies on vaccine safety.
• Comparison of the immunologic and physiologic effects of different combinations of vaccines, or vaccine antigens formulated with different adjuvants, and different schedules.

Eligibility
• Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
• Applications from Foreign Organizations: Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Funding
• Application budgets are not limited but need to reflect the actual needs of the proposed project. Applicants requesting USD $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/Research Contact at the NIH at least 6 weeks before submitting the application.
• The scope of the project should determine the project period. The maximum project period is 5 years.

Please see the Funding Opportunity Announcement for further information. Applications may be prepared and submitted via the NIH ASSIST system or Grants.gov. For complete instructions, you must refer to both the NIH Application Guide and the Funding Opportunity Announcement (FOA), noting that instructions in the FOA take precedence over the Application Guide.

Key Dates
Letter of Intent (non-mandatory) due to NIH: Not Applicable
Applications due to UQR&I: 22 January 2019
Applications close with NIH: 5 February 2019, 5:00pm local time of applicant organisation
Future application closing dates: Standard dates apply until expiry
Expiration date of FOA: 8 September 2021

Ahead of internal review, ensure all online components on ASSIST or Grants.gov are complete. To initiate review, email your completed Funding Application Coversheet to internationalgrants@research.uq.edu.au. Interested applicants are strongly encouraged to make contact with the UQR&I international team (via internationalgrants@research.uq.edu.au) well in advance of the UQR&I internal deadline to discuss their application.
Website: http://grants.nih.gov/grants/guide/pa-files/PA-18-873.html

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