NIH/NIAID – Research to Advance Vaccine Safety (R01, R21 Clinical Trial Not Allowed)

August 1, 2018 by School of Medicine Webmaster

The following description was taken from the R01 version of this FOA.

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 .


Vaccines have led to some of the greatest public health achievements in history, including the worldwide eradication of naturally occurring smallpox and the near-eradication of polio. In addition, vaccines have contributed to significant reduction in the disease burden imposed by measles, mumps, hepatitis, influenza, diphtheria, and many other infections. The science of vaccinology is dynamic – it unfolds as technology enables scientists to continue to create safer and more effective vaccines.

Vaccine safety is an integral part of every aspect of vaccine development and evaluation. Despite the rigorous evaluation process, in recent years some members of the public have raised concerns about potential relationships between vaccines and particular diseases or adverse events. A series of Institute of Medicine reviews (2001 to 2004, 2012 and 2013) evaluated the state of the science for specific vaccine safety topics and recommended research activities to help address key areas. New research advances our knowledge, generates new questions, and opens novel avenues for exploration. NIH is interested in encouraging research to address important scientific questions relating to vaccine safety.

Research Objectives

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.

Deadlines:  standard dates and standard AIDS dates apply


Filed Under: Funding Opportunities