NIAID supports a spectrum of research, from basic studies in allergy and immunology to food allergy clinical trials. Through these efforts, NIAID-funded scientists and clinicians are making significant progress in combating food allergies that affect millions of children and adults worldwide.
Consortium of Food Allergy Research (CoFAR)
CoFAR was established in fiscal year (FY) 2005 to support clinical research on food allergy. It was renewed in FY 2010 to continue several promising clinical studies from the original consortium and expanded to include research on the genetic causes underlying food allergy and the mechanisms of food allergy-associated eosinophilic esophagitis (EoE).
The following are the goals of the expanded CoFAR:
- Identify the mechanisms underlying the development of new food allergy and the mechanisms of loss of food allergy (i.e., emergence of oral tolerance to food allergens)
- Develop immune intervention strategies for the treatment of food allergy
- Identify the role of food allergy in EoE, and compare the genetic markers of EoE with those of food allergy involving immunoglobulin E (IgE), the primary antibody associated with allergic reactions
- Identify the genes associated with food allergy
Investigators supported by the first CoFAR program initiated one observational study and three clinical trials in food allergy research, all of which continue under the current program.
The observational study has enrolled infants ages 3 to 15 months with known allergies to egg and/or milk, but without clinical peanut allergy. The study is evaluating differences in immunologic changes and biological markers in the infants who develop peanut allergy compared to those who do not. It also is evaluating immunologic changes and biologic markers in the infants who lose their allergy to egg and/or milk compared to those whose allergy persists.
One clinical trial is studying children ages 5 to 18 years old who ingest egg powder as a potential treatment for egg allergy. A second trial is looking at individuals 12 years and older who receive an extract of modified peanut under the tongue as a potential therapy for peanut allergy. A third trial is examining the safety of genetically modified peanut allergens encapsulated within heat-killed bacteria and given rectally to adults as a potential therapy for peanut allergy. Other clinical studies are in the planning and development stages.
The AADCRC program is the main component of the NIAID asthma and allergy research portfolio that focuses on the biological mechanisms of allergy. Established in 1971, the program is now in its fourth decade of continuous funding. Fifteen centers located throughout the United States conduct basic and clinical research on the mechanisms, diagnosis, treatment, and prevention of asthma and allergic diseases, including food allergy and anaphylaxis, a severe allergic reaction that can be life-threatening.
AADCRC projects include the following:
- A clinical trial to determine whether extensively heated milk in baked products can be tolerated by milk-allergic individuals, and if so, whether regular feeding of baked milk products can reduce the severity of milk allergy
- A clinical trial to determine whether oral immunotherapy with milk extract, combined with regular injections of anti-IgE, can reduce the severity of milk allergy
- Studies of the pathogenesis of EoE
- Studies of the capacity of anti-IgE to prevent allergic reactions to food
Established in 1999, ITN is an international consortium of researchers dedicated to the development and evaluation of novel tolerance-inducing therapies for immune-mediated disorders, including allergic diseases. Co-sponsored by NIAID and the Juvenile Diabetes Research Foundation International, ITN currently is conducting two clinical trials designed to uncover the basic biological mechanisms of early-life allergen exposure and its effect on the development of allergic diseases, including food allergy.
The first trial, Learning Early About Peanut Allergy (LEAP) study, will determine whether early (beginning at ages 4 to 10 months) and regular consumption of a peanut snack by children at risk of developing peanut allergy will prevent the development of this allergy. A total of 640 infants have been enrolled, half will consume the peanut snack and half will completely avoid peanuts. Both groups will be evaluated until they reach 5 years old. Because recent studies have demonstrated that the frequent consumption of food may make true tolerance difficult to assess, the trial has been extended for one year (until all enrolled reach age 6), during which all participants will avoid peanuts to help determine the long-term effects of consuming the peanut snack on tolerance.
For more information, visit the LEAP website.
In the second trial, oral mucosal immunotherapy with dust mite, cat, and Timothy grass allergens will be given for a year to children between the ages of 18 and 30 months to determine if the therapy reduces the development of allergy to these allergens, to other allergens, and/or asthma.
ICAC is an NIAID-supported research network started in FY 2002 to improve the treatment of children living in environments where the prevalence and severity of asthma is particularly high. The first phase of ICAC began an observational study to determine if there is a correlation between food sensitization and the onset of asthma later in life. This study is continuing under the second phase of ICAC.
Exploratory Investigations in Food Allergy
This initiative, first established in 2008 and renewed in 2010, aims to stimulate innovative, high-impact food allergy research studies and to encourage the participation of investigators new to this area of research. It is co-sponsored by NIAID, the Food Allergy and Anaphylaxis Network, and the Food Allergy Initiative. The U.S. Environmental Protection Agency provided additional support for this initiative in 2008.
Under these programs, investigators address key questions aimed at improving treatment and prevention of food allergy and furthering the understanding of mechanisms and risk factors associated with food allergy. Individual project goals include the following:
- Predicting which food proteins are likely to cause allergic reactions
- Identifying the factors that trigger severe responses
- Determining the contribution of other immune disorders, such as asthma and eczema, to food allergy
- Defining the genetics of food allergy
- Understanding the role of interactions between genes and the environment in food allergy pathogenesis
Allergen and T-Cell Reagent Resources for the Study of Allergic Diseases
In 2005, NIAID sponsored a workshop on the future of immunotherapy for allergic diseases. One of the recommendations of the panel was to "expand chemical characterization of known and novel allergens." As a result, in FY 2007 NIAID awarded two contracts for the identification, development, and validation of T-cell allergen epitopes (parts of allergens that T cells in the immune system bind to) from a variety of clinically important allergens involved in diseases such as asthma, hay fever (allergic rhinitis), and food allergy.
Findings from this research are deposited into the publicly available Immune Epitope Database and used by the research community in the study of allergic diseases.