Key Dates

Related Announcements

• May 05, 2020 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed). See NOFO PA-20-185.

Issued by

National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

This Notice of Special Interest (NOSI) is to solicit applications proposing studies utilizing available biologic and environmental samples collected as part of the birth cohort study, Systems Biology of Early Atopy (SUNBEAM, NCT04798079), to discover and advance the understanding of novel and established clinical, environmental, biological, and genetic early-life factors in the development of allergic diseases. Studies using these samples are expected to give a deeper understanding of mechanisms contributing to the development of allergic diseases, disease endotypes, and will identify molecular targets for disease prevention.

SUNBEAM is collecting biologic and environmental samples as well as health and exposure history from parents and offspring from the time of enrollment (during gestation; samples and data from the parents) through 3 years of age (samples and data taken from parents and offspring) for rigorous analyses. In addition, SUNBEAM is evaluating the offspring for food allergy (FA) and atopic dermatitis (AD) at every study visit starting at the 2-month visit, for allergic rhinitis and conjunctivitis starting at the 24-month visit, and for recurrent wheeze at the 36-month visit. The SUNBEAM biologic samples are being collected and stored to allow for extensive omics approaches, including genomic, epigenomic, transcriptomic, proteomic, metabolomic, and microbiomic analyses. SUNBEAM samples are being collected from:

• The newborn/infant/child: cord blood, peripheral blood (whole blood, plasma and serum), skin tape strips, skin and nasal swabs, nasal secretions, urine, saliva, stool, hair
• The mother: peripheral blood (whole blood, plasma and serum), skin tape strips, breast milk, skin and vaginal swabs, urine, hair, stool
• The father: peripheral blood (whole blood, plasma and serum), skin tape strips, skin and nasal swabs, stool
• The home: house dust

SUNBEAM is supported by the SUNBEAM-Analysis and Bioinformatics Center (ABC). SUNBEAM-ABC will produce omic data from a discrete number of biologic samples collected within the SUNBEAM cohort and will use systems biology to identify determinants of atopic disease, focusing on FA and AD. SUNBEAM-ABC will conduct whole blood transcriptomics, high parameter cytometry analysis of fixed blood cells and will generate other omics data derived from SUNBEAM.

SUNBEAM primary clinical analyses will utilize a case/cohort design and will take advantage of the longitudinal nature of the samples collected in the birth cohort. Within the case/cohort, SUNBEAM-ABC will identify a subset of offspring participants with AD, FA, both or neither. The samples from this defined set of participants (SUNBEAM Common Sample) will be used by SUNBEAM-ABC and independent projects to generate a multi-omic data set to facilitate the systems biology goals of SUNBEAM. Projects proposed under this NOSI can focus on the Common Sample participants (provided sample availability) but can also propose to utilize samples that are outside the Common Sample and/or outside the case/cohort design.

The studies proposed under this NOSI must adhere to guidelines that have been established by the SUNBEAM Steering Group for managing SUNBEAM samples. Potential applicants are highly encouraged to first communicate with the NIH Scientific/Research contact listed below to discuss the SUNBEAM sample management guidelines and sample availability. Applicants are strongly encouraged to establish an agreement with the SUNBEAM Steering Group prior to submission; a collaboration letter reflecting this agreement can be included as a letter of support. The NIH Scientific/Research contact will help establish communication between the applicant and the SUNBEAM Steering Group.

Please consult the FAQ for information about the SUNBEAM, including the SUNBEAM protocol.

Research Objectives and Scope:

Research areas of interest to this NOSI include, but are NOT limited to:

• Identification of biological pathways associated with the development of allergic disease (AD, FA, and respiratory allergy) in early life
• Identification of endotypes of allergic disease (AD, FA, and respiratory allergy) in early life
• Elucidation of microbial factors associated with the development of allergic disease (AD, FA, and respiratory allergy)
• Identification of biomarkers and biomarker-based models that predict the development of or indicate the presence of early allergic disease (AD, FA, and respiratory allergy)
• Understanding the role of early environmental exposures on the development of allergic disease (AD, FA, and respiratory allergy)

Applications proposing any of the following topics will not be supported under this NOSI:

• Assay development
• Collection of samples not already specified in the protocol
• Primary focus on clinical data and not on sample analyses
  

Application and Submission Information

This notice applies to due dates on or after October 5, 2023 and subsequent receipt dates through July 5, 2026.

Submit applications for this initiative using one of the following notices of funding opportunities (NOFOs) or any reissues of these announcements through the expiration date of this notice.

• PA-20-185 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

• For funding consideration, applicants must include NOT-AI-23-058 (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

Inquiries

Please direct all inquiries to the contacts in Section VII of the listed notice of funding opportunity with the following additions/substitutions:

Scientific/Research Contact(s)

Patricia C. Fulkerson, M.D., Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 202-641-4535
Email: patricia.fulkerson@nih.gov

Gang Dong, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3508
Email: gdong@niaid.nih.gov

Financial/Grants Management Contact(s)

Tamia Powell
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2982
Email: tamia.powell@nih.gov