Notice Number: NOT-AI-09-050
Key Dates
Release Date: July 31, 2009
Issued by
National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov)
Purpose
The purpose of this Amendment is to provide additional clarification/language for the following NIAID program announcements:
Research to Advance Vaccine Safety (R01) PA-08-256 http://grants.nih.gov/grants/guide/pa-files/PA-08-256.html
Research to Advance Vaccine Safety (R21) PA-08-257 http://grants.nih.gov/grants/guide/pa-files/PA-08-257.html
The following bolded language has been added to both FOAs:
Executive Summary
- Purpose. This FOA, entitled Research to Advance Vaccine Safety, is issued by the National Institutes of Health and encourages Research Project Grant (R01) applications from institutions/organizations that propose to support research that will contribute to the overall understanding of vaccine safety. This R01 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.
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
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.
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
Section VII. Agency Contacts
- Scientific/Research Contacts:
ADDITIONAL CONTACT:
Misrak Gezmu, Ph.D.
Mathematical Statistician
National Institute of Allergy and Infectious Diseases
6700B Rockledge Dr. MSC 7609
Bethesda, MD 20892-7609
Tel: 301-435-3722
Fax: 301-480-0912
Email: [email protected]
and Human Services (HHS)
