Open Access Research

Peanut Allergen Threshold Study (PATS): validation of eliciting doses using a novel single-dose challenge protocol

Giovanni A Zurzolo12, Katrina J Allen134, Steve L Taylor5, Wayne G Shreffler6, Joseph L Baumert5, Mimi L K Tang134, Lyle C Gurrin7, Michael L Mathai2, Julie A Nordlee5, Audrey DunnGalvin8 and Jonathan O’B Hourihane8*

Author Affiliations

1 Murdoch Childrens Research Institute, Melbourne, Australia

2 Biomedical and Lifestyle Diseases Unit, School of Biomedical and Health Sciences, Victoria University, Melbourne, Australia

3 Department of Allergy and Immunology, Royal Children’s Hospital, Melbourne, Australia

4 University of Melbourne Department of Paediatrics, Melbourne, Australia

5 Food Allergy Research and Resource Program, University of Nebraska, Lincoln, Nebraska

6 Food Allergy Centre and the Centre for Immunology and Inflammatory Disease, Massachusetts General Hospital/Harvard Medical School, Boston, USA

7 Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia

8 Paediatrics and Child Health, University College, Cork, Ireland

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Allergy, Asthma & Clinical Immunology 2013, 9:35  doi:10.1186/1710-1492-9-35

Published: 12 September 2013

Abstract

Background

The eliciting dose (ED) for a peanut allergic reaction in 5% of the peanut allergic population, the ED05, is 1.5 mg of peanut protein. This ED05 was derived from oral food challenges (OFC) that use graded, incremental doses administered at fixed time intervals. Individual patients’ threshold doses were used to generate population dose-distribution curves using probability distributions from which the ED05 was then determined. It is important to clinically validate that this dose is predictive of the allergenic response in a further unselected group of peanut-allergic individuals.

Methods/Aims

This is a multi-centre study involving three national level referral and teaching centres. (Cork University Hospital, Ireland, Royal Children’s Hospital Melbourne, Australia and Massachusetts General Hospital, Boston, U.S.A.) The study is now in process and will continue to run until all centres have recruited 125 participates in each respective centre.

A total of 375 participants, aged 1–18 years will be recruited during routine Allergy appointments in the centres. The aim is to assess the precision of the predicted ED05 using a single dose (6 mg peanut = 1.5 mg of peanut protein) in the form of a cookie. Validated Food Allergy related Quality of Life Questionnaires-(FAQLQ) will be self-administered prior to OFC and 1 month after challenge to assess the impact of a single dose OFC on FAQL. Serological and cell based in vitro studies will be performed.

Conclusion

The validation of the ED05 threshold for allergic reactions in peanut allergic subjects has potential value for public health measures. The single dose OFC, based upon the statistical dose-distribution analysis of past challenge trials, promises an efficient approach to identify the most highly sensitive patients within any given food-allergic population.

Keywords:
Eliciting dose (ED); Food Allergy related Quality of Life Questionnaires-(FAQLQ); Single dose; Peanut thresholds; Oral Food Challenges (OFC); Voluntary Incidental Trace Allergen Labelling (VITAL); Peanut Allergen Threshold Study (PATS)