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ID#: PA-12-037     Posted: 7 Mar 2012
Research to Advance Vaccine Safety (R01)
Deadline: 5 Oct 2012
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Type of Grant: Research
Topics/Fields of Support: Adjuvants, Animal model studies, B cell immunology and antibodies, Human genomics, Innate immunity, Mucosal immunity, Novel immunogens, inserts and vectors, Pediatric/adolescent infections and trials, Preclinical and clinical vaccine trials, Prevention strategies, T cell immunity, Vaccine concepts and design, Other
National Institute of Allergy and Infectious Diseases, NIH

The National Institute of Allergy and Infectious Diseases (NIAID) conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. For more than 60 years, NIAID research has led to new therapies, vaccines, diagnostic tests, and other technologies that have improved the health of millions of people in the United States and around the world. NIAID is one of the 27 Institutes and Centers of the National Institutes of Health (NIH). NIH, like the Centers for Disease Control and Prevention (CDC), is part of the U. S. Department of Health and Human Services (HHS). NIH is the primary federal agency for conducting and supporting basic, clinical, and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, please visit NIH (

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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 invites studies that address scientific areas potentially relevant to vaccine safety such as

1) physiological and immunological responses to vaccines and vaccine components,

2) how genetic variations affect immune/physiological responses that may impact vaccine safety,

3) identification of risk factors 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

5) the application of genomic/molecular technologies to improve knowledge of vaccine safety.

This Funding Opportunity Announcement 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) evaluated the state of the science for specific vaccine safety topics and recommended research activities to help address key areas. Since that time, scientific research has advanced our knowledge in many areas. Because this knowledge continuously generates new questions and opens new avenues for exploration, NIH is interested in encouraging research to address important scientific questions relating to vaccine safety.  As noted above, this Funding Opportunity Announcement aligns with the research goals and objectives outlined in the U.S. National Vaccine Plan (

Examples of research topics include, but are not limited to:

  • Detailed evaluation of various host immune/physiological responses to currently licensed vaccine antigens and/or adjuvant combinations
  • Evaluation of existing childhood immunization schedules to optimize safe and long-term protective immune memory
  • Studies that define the capacity and quality of the immune response throughout infancy and childhood. Can vaccines be further optimized to minimize the need for secondary immunizations?
  • Identification of the molecular basis for differential immune/physiologic responses to vaccination at different stages of life or when underlying health problems exist
  • Studies to determine if there are associations between genetic variations among individuals and susceptibility to serious adverse events in response to vaccination
  • Identification of risk factors and biological markers that would allow for assessment of whether there is a relationship between certain diseases or disorders and licensed vaccines
  • Creation/evaluation of statistical methodologies to provide rigorous analysis of vaccine safety data from existing sources including passive reporting systems (e.g., Vaccine Safety Datalink; Vaccine Adverse Events Reporting System) and to establish novel approaches to designing studies on vaccine safety. 
  • Comparison of the immunologic and physiologic effects of different combinations of vaccines and different schedules

Eligible Individuals (Program Director(s)/Principal Investigator(s))

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.   


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