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

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dc.contributor.author Zurzolo, Giovanni A.
dc.contributor.author Allen, Katrina J.
dc.contributor.author Taylor, Steve L.
dc.contributor.author Shreffler, Wayne G.
dc.contributor.author Baumert, Joseph L.
dc.contributor.author Tang, Mimi L. K.
dc.contributor.author Gurrin, Lyle C.
dc.contributor.author Mathai, Michael L.
dc.contributor.author Nordlee, Julie A.
dc.contributor.author Dunn Galvin, Audrey
dc.contributor.author Hourihane, Jonathan O'B.
dc.date.accessioned 2013-12-04T17:29:03Z
dc.date.available 2013-12-04T17:29:03Z
dc.date.copyright 2013
dc.date.issued 2013-09-12
dc.identifier.citation ZURZOLO, G. A., ALLEN, K. J., TAYLOR, S. L., SHREFFLER, W. G., BAUMERT, J. L., TANG, M. L. K., GURRIN, L. C., MATHAI, M. L., NORDLEE, J. A., DUNNGALVIN, A., HOURIHANE, J . O'B. 2013. Peanut Allergen Threshold Study (PATS): validation of eliciting doses using a novel single-dose challenge protocol. Allergy, Asthma & Clinical Immunology 2013 9 :35 doi: 10.1186/1710-1492-9-35 en
dc.identifier.volume 9 en
dc.identifier.startpage 35 en
dc.identifier.uri http://hdl.handle.net/10468/1273
dc.identifier.doi 10.1186/1710-1492-9-35
dc.description.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. en
dc.format.mimetype application/pdf en
dc.language.iso en en
dc.publisher BioMed Central en
dc.relation.uri http://www.aacijournal.com/content/9/1/35
dc.rights © 2013 Zurzolo et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. en
dc.rights.uri http://creativecommons.org/licenses/by/2.0 en
dc.subject Eliciting dose (ED) en
dc.subject Food Allergy related Quality of Life Questionnaires-(FAQLQ) en
dc.subject Single dose en
dc.subject Peanut thresholds en
dc.subject Oral Food Challenges (OFC) en
dc.subject Voluntary Incidental Trace Allergen Labelling (VITAL) en
dc.subject Peanut Allergen Threshold Study (PATS) en
dc.title Peanut Allergen Threshold Study (PATS): validation of eliciting doses using a novel single-dose challenge protocol en
dc.type Article (peer-reviewed) en
dc.internal.authorcontactother Jonathan Hourihane, Paediatrics & Child Health, University College Cork, Cork, Ireland. +353-21-490-3000 Email: j.hourihane@ucc.ie en
dc.internal.availability Full text available en
dc.date.updated 2013-09-19T09:24:03Z
dc.description.version Published Version en
dc.internal.rssid 230528449
dc.internal.rssid 348783355
dc.internal.rssid 348783355
dc.description.status Peer reviewed en
dc.identifier.journaltitle Allergy, Asthma & Clinical Immunology en
dc.internal.copyrightchecked No. CORA - ROMEO - Open Access journal. CC-BY licence en
dc.internal.licenseacceptance Yes en
dc.internal.IRISemailaddress j.hourihane@ucc.ie en


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© 2013 Zurzolo et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Except where otherwise noted, this item's license is described as © 2013 Zurzolo et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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