U01AI192609
Cooperative Agreement
Overview
Grant Description
The Oral Environment in Food Allergy Development (ONEIDA) - Project Summary
Food allergy, an incurable condition affecting ~10% of the US population, is a departure from immune homeostasis where aberrant antibody response, microbial dysbiosis, and local and systemic symptoms are well-reported.
With exposure to culprit foods, individuals with food allergy experience symptoms including oral swelling, hives, vomiting, and anaphylaxis.
The oral mucosa is the first interface between ingested food antigens and the immune system.
Our studies have revealed differences in food-specific antibody levels in saliva between food allergic children and those who are only food sensitized.
We have shown that allergen-specific antibody profiles in saliva can predict food allergy threshold, severity, and organ-specific symptoms.
We have also found that the saliva microbiome and metabolome differ in children with and without food allergy.
Building on this work, we aim to study the origins of food allergy and propose to characterize the early-life trajectory of the oral environment as food allergy arises.
To date, there has been no study of the oral environment as children acquire food allergy.
Our central hypothesis is that the development of food allergy is associated with distinct trajectories during the first three years of life in oral mucosal immunology, oral microbial communities and metabolites, and their cross-talk with systemic factors.
We will leverage longitudinal samples and existing data from the NIH/NIAID Systems Biology of Early Atopy (SUNBEAM) study, a multi-center birth cohort of 2,500 children from across the US who have undergone extensive longitudinal phenotyping, including doctor-supervised food challenges for food allergy assessment.
We have been leading and working on SUNBEAM since it began.
To address our first hypothesis that the inception of food allergy is associated with a distinct oral mucosal immunologic trajectory, we will characterize the development of allergen-specific antibodies and cytokine milieu in saliva during the first 3 years of life and identify saliva antibody and cytokine predictors of food allergy inception (Aim 1).
To address our second hypothesis that children who attain food allergy host different oral microbial communities and metabolites, we will profile the saliva microbiome and metabolome during the first 3 years of life and chart microbial and metabolite dynamics associated with food allergy acquisition (Aim 2).
Our third hypothesis is that directional cross-talk between the oral and systemic environments is associated with food allergy development.
We will build temporal networks and employ causal methods to integrate the multi-dimensional oral data generated by this study with multi-omic systemic data that we have in hand for the same participants to identify directional relationships between the oral and systemic environments over time and their causal impact on food allergy onset (Aim 3).
This study will generate unprecedented findings on the immunologic, microbial, and metabolomic trajectories of the early-life oral environment and their relationship with food allergy development.
Findings could inform food allergy prevention and biomarkers using non-invasive saliva samples.
Food allergy, an incurable condition affecting ~10% of the US population, is a departure from immune homeostasis where aberrant antibody response, microbial dysbiosis, and local and systemic symptoms are well-reported.
With exposure to culprit foods, individuals with food allergy experience symptoms including oral swelling, hives, vomiting, and anaphylaxis.
The oral mucosa is the first interface between ingested food antigens and the immune system.
Our studies have revealed differences in food-specific antibody levels in saliva between food allergic children and those who are only food sensitized.
We have shown that allergen-specific antibody profiles in saliva can predict food allergy threshold, severity, and organ-specific symptoms.
We have also found that the saliva microbiome and metabolome differ in children with and without food allergy.
Building on this work, we aim to study the origins of food allergy and propose to characterize the early-life trajectory of the oral environment as food allergy arises.
To date, there has been no study of the oral environment as children acquire food allergy.
Our central hypothesis is that the development of food allergy is associated with distinct trajectories during the first three years of life in oral mucosal immunology, oral microbial communities and metabolites, and their cross-talk with systemic factors.
We will leverage longitudinal samples and existing data from the NIH/NIAID Systems Biology of Early Atopy (SUNBEAM) study, a multi-center birth cohort of 2,500 children from across the US who have undergone extensive longitudinal phenotyping, including doctor-supervised food challenges for food allergy assessment.
We have been leading and working on SUNBEAM since it began.
To address our first hypothesis that the inception of food allergy is associated with a distinct oral mucosal immunologic trajectory, we will characterize the development of allergen-specific antibodies and cytokine milieu in saliva during the first 3 years of life and identify saliva antibody and cytokine predictors of food allergy inception (Aim 1).
To address our second hypothesis that children who attain food allergy host different oral microbial communities and metabolites, we will profile the saliva microbiome and metabolome during the first 3 years of life and chart microbial and metabolite dynamics associated with food allergy acquisition (Aim 2).
Our third hypothesis is that directional cross-talk between the oral and systemic environments is associated with food allergy development.
We will build temporal networks and employ causal methods to integrate the multi-dimensional oral data generated by this study with multi-omic systemic data that we have in hand for the same participants to identify directional relationships between the oral and systemic environments over time and their causal impact on food allergy onset (Aim 3).
This study will generate unprecedented findings on the immunologic, microbial, and metabolomic trajectories of the early-life oral environment and their relationship with food allergy development.
Findings could inform food allergy prevention and biomarkers using non-invasive saliva samples.
Funding Goals
TO ASSIST PUBLIC AND PRIVATE NONPROFIT INSTITUTIONS AND INDIVIDUALS TO ESTABLISH, EXPAND AND IMPROVE BIOMEDICAL RESEARCH AND RESEARCH TRAINING IN INFECTIOUS DISEASES AND RELATED AREAS, TO CONDUCT DEVELOPMENTAL RESEARCH, TO PRODUCE AND TEST RESEARCH MATERIALS. TO ASSIST PUBLIC, PRIVATE AND COMMERCIAL INSTITUTIONS TO CONDUCT DEVELOPMENTAL RESEARCH, TO PRODUCE AND TEST RESEARCH MATERIALS, TO PROVIDE RESEARCH SERVICES AS REQUIRED BY THE AGENCY FOR PROGRAMS IN INFECTIOUS DISEASES, AND CONTROLLING DISEASE CAUSED BY INFECTIOUS OR PARASITIC AGENTS, ALLERGIC AND IMMUNOLOGIC DISEASES AND RELATED AREAS. PROJECTS RANGE FROM STUDIES OF MICROBIAL PHYSIOLOGY AND ANTIGENIC STRUCTURE TO COLLABORATIVE TRIALS OF EXPERIMENTAL DRUGS AND VACCINES, MECHANISMS OF RESISTANCE TO ANTIBIOTICS AS WELL AS RESEARCH DEALING WITH EPIDEMIOLOGICAL OBSERVATIONS IN HOSPITALIZED PATIENTS OR COMMUNITY POPULATIONS AND PROGRESS IN ALLERGIC AND IMMUNOLOGIC DISEASES. BECAUSE OF THIS DUAL FOCUS, THE PROGRAM ENCOMPASSES BOTH BASIC RESEARCH AND CLINICAL RESEARCH. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM EXPANDS AND IMPROVES PRIVATE SECTOR PARTICIPATION IN BIOMEDICAL RESEARCH. THE SBIR PROGRAM INTENDS TO INCREASE AND FACILITATE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. THE SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM STIMULATES AND FOSTERS SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. RESEARCH CAREER DEVELOPMENT AWARDS SUPPORT THE DEVELOPMENT OF SCIENTISTS DURING THE FORMATIVE STAGES OF THEIR CAREERS. INDIVIDUAL NATIONAL RESEARCH SERVICE AWARDS (NRSAS) ARE MADE DIRECTLY TO APPROVE APPLICANTS FOR RESEARCH TRAINING IN SPECIFIED BIOMEDICAL SHORTAGE AREAS. IN ADDITION, INSTITUTIONAL NATIONAL RESEARCH SERVICE AWARDS ARE MADE TO ENABLE INSTITUTIONS TO SELECT AND MAKE AWARDS TO INDIVIDUALS TO RECEIVE TRAINING UNDER THE AEGIS OF THEIR INSTITUTIONAL PROGRAM.
Grant Program (CFDA)
Awarding / Funding Agency
Place of Performance
New York
United States
Geographic Scope
State-Wide
Related Opportunity
Icahn School Of Medicine At Mount Sinai was awarded
Early-Life Oral Environment and Food Allergy Development Study
Cooperative Agreement U01AI192609
worth $6,732,986
from the National Institute of Allergy and Infectious Diseases in August 2025 with work to be completed primarily in New York United States.
The grant
has a duration of 3 years 10 months and
was awarded through assistance program 93.855 Allergy and Infectious Diseases Research.
The Cooperative Agreement was awarded through grant opportunity NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed).
Status
(Ongoing)
Last Modified 7/25/25
Period of Performance
8/1/25
Start Date
6/30/29
End Date
Funding Split
$6.7M
Federal Obligation
$0.0
Non-Federal Obligation
$6.7M
Total Obligated
Activity Timeline
Additional Detail
Award ID FAIN
U01AI192609
SAI Number
U01AI192609-3696847797
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Private Institution Of Higher Education
Awarding Office
75NM00 NIH National Institute of Allergy and Infectious Diseases
Funding Office
75NM00 NIH National Institute of Allergy and Infectious Diseases
Awardee UEI
C8H9CNG1VBD9
Awardee CAGE
1QSQ9
Performance District
NY-90
Senators
Kirsten Gillibrand
Charles Schumer
Charles Schumer
Modified: 7/25/25