This K23 award application describes a career development plan for Dr. Brian Vickery, an Instructor in the Division of Pediatric Allergy and Immunology at Duke University Medical Center. This award will provide Dr. Vickery with the necessary support and training to develop into an independent physician-investigator specializing in allergic disorders of childhood. Specifically, the award will enable Dr. Vickery to accomplish the following goals: (1) to master skills necessary to design and execute clinical trials;(2) to become proficient in advanced biostatistical skills suitable for analysis of longituinal studies;(3) to develop expertise in mechanistic immune monitoring assays;and (4) to achieve an independent research career conducting high-impact patient- oriented research focusing on immune tolerance-based therapies for allergic disorders. To accomplish these goals, Dr. Vickery has assembled a mentorship advisory committee led by Dr. Wesley Burks, an international expert in food allergy and immunological tolerance. Dr. Burks will lead a team of other renowned investigators with extensive mentorship experience, whose scientific interests collectively include basic and translational immunology, pediatric pharmacology, and clinical trials. Dr. Vickery will complement this intensive career development guidance with advanced didactic coursework in biostatistics, research design, pharmacology, and advanced laboratory methods. Peanut allergy is a severe and potentially fatal immunologic problem affecting approximately 1% of children in the U.S. and other developed nations. Without an effective disease-modifying therapy, patients suffer significant physical and psychological morbidity, including the profound reduction in quality of life that results from an ever-present risk of life-threatening anaphylaxis Based on recent studies highlighting the potential plasticity of allergic responses early in life, and the role of oral exposure during this critical period, we have designed a single-center randomized clinical trial to test early intervention with low-dose and high-dose peanut oral immunotherapy (OIT) in 40 newly diagnosed peanut-allergic children aged 9 - 36 months. The goals of this project are: to produce a new treatment that would rapidly benefit peanut-allergic subjects, by transiently altering reactivity and lowering the risk of anaphylaxis while on treatmen (i.e., desensitization) (Aim I);to assess the ability of this treatment to permanently alter the peanut-specific immune response over time, allowing discontinuation of therapy (i.e., tolerance) (Aim I);and to understand its mechanism of action (Aim II). While providing a mentored training experience in clinical research, this innovative trial focuses directly on several critical knowlede gaps that must be addressed in order to develop the first clinically available food allergy treatment and change the standard of care. The outcome of this work has the potential to change the way peanut allergy is treated, by developing a safe, inexpensive, feasible, and effective disease-modifying therapy that could be made immediately available to infants and toddlers. This project will study early intervention with peanut oral immunotherapy in young children, generate important new scientific knowledge of immunologic tolerance in humans, and examine the impact of treatment on health-related quality of life.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Mentored Patient-Oriented Research Career Development Award (K23)
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Study Section
Allergy & Clinical Immunology-1 (AITC)
Program Officer
Prograis, Lawrence J
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University of North Carolina Chapel Hill
Schools of Medicine
Chapel Hill
United States
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Kulis, Michael; Yue, Xiaohong; Guo, Rishu et al. (2018) High- and low-dose oral immunotherapy similarly suppress pro-allergic cytokines and basophil activation in young children. Clin Exp Allergy :
Virkud, Yamini V; Burks, A Wesley; Steele, Pamela H et al. (2017) Novel baseline predictors of adverse events during oral immunotherapy in children with peanut allergy. J Allergy Clin Immunol 139:882-888.e5
Vickery, Brian P; Berglund, Jelena P; Burk, Caitlin M et al. (2017) Early oral immunotherapy in peanut-allergic preschool children is safe and highly effective. J Allergy Clin Immunol 139:173-181.e8
Vickery, Brian P (2016) Low dose immunotherapy in very young children to treat peanut allergy. Expert Rev Clin Immunol 12:1251-1253
Burk, C M; Kulis, M; Leung, N et al. (2016) Utility of component analyses in subjects undergoing sublingual immunotherapy for peanut allergy. Clin Exp Allergy 46:347-53
Hobbs, Caroline B; Skinner, Asheley C; Burks, A Wesley et al. (2015) Food allergies affect growth in children. J Allergy Clin Immunol Pract 3:133-4.e1
Greenhawt, Matthew J; Vickery, Brian P (2015) Allergist-reported trends in the practice of food allergen oral immunotherapy. J Allergy Clin Immunol Pract 3:33-8
Sampson, Hugh A; Aceves, Seema; Bock, S Allan et al. (2014) Food allergy: a practice parameter update-2014. J Allergy Clin Immunol 134:1016-25.e43
Vickery, Brian P; Scurlock, Amy M; Kulis, Michael et al. (2014) Sustained unresponsiveness to peanut in subjects who have completed peanut oral immunotherapy. J Allergy Clin Immunol 133:468-75
Chin, Stacy J; Vickery, Brian P; Kulis, Michael D et al. (2013) Sublingual versus oral immunotherapy for peanut-allergic children: a retrospective comparison. J Allergy Clin Immunol 132:476-8.e2

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