Role of Recombinants in Peach Allergy

Classification of Different Forms of Peach Allergy and the Role of Recombinant Allergens in the Diagnosis

This study is aimed at verifying the role and the efficacy of the recombinants allergens Pru p 1, Pru p 3 and Pru p 4, Bet v 1, Bet v 2 and Bet v 4 in the diagnosis of peach allergy

Study Overview

• Status: Completed
• Conditions: Food Allergy

Detailed Description

This study intend to verify whether the different levels of severity of the clinical allergic reactions to peach are associated to sensitization towards different allergenic molecules of peach. In particular, we will analyze the reactivity towards the peach allergens Pru p 1, Pru p 3 and Pru p 4 and towards the birch pollen allergens Bet v 1, Bet v 2 and Bet v 4. The patients (with allergic symptoms of any severity provoked by the consumption of peach) will be divided into two groups: the first group showing oral allergy syndrome (OAS), the second group showing systemic symptoms of different severity, up to anaphylaxis.

All the patients will be submitted to: complete clinical investigation; skin prick test with a panel of common food/inhalant commercial extracts; skin tests by the "prick + prick" method with fresh fruits and vegetables; skin prick test with purified peach LTP (Pru p 3) The sera of the patients will be used for: immunoblotting with peach extract and immunoblotting inhibition with purified natural Pru p 3 and, if possible, recombinant Pru p 3, Pru p 1 and Pru p 4, using a pool of selected sera; CAP system with a predetermined panel of fruit and vegetable allergens; CAP system with recombinant allergens of peach and birch pollen: Pru p 3, Pru p 1 and Pru p 4 for peach, Bet v 1, Bet v 2 and Bet v 4 for birch pollen. Finally, a statistical analysis will be carried out in order to verify if the two groups of patients will show significant differences in the allergens recognized. The results of this study will be a property of the Unit of Allergology and Immunology as stated by DM 17/2004 and will be presented as written publication or oral presentation at National and/or International Congresses of Allergy and Immunology, quoting the PHADIA company

• Study Type: Observational
• Enrollment (Actual): 148

Contacts and Locations

Study Locations

• Italy
  • Milano, Italy, 20162
    • Niguarda Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Peach allergic subjects at major risk of anaphylaxis

Description

Inclusion Criteria:

• female and male;
• pts with 18 e 80 years old;
• signature of the informed consent form;
• CAP/RAST positive for peach;
• clinical manifestation of peach allergy

Exclusion Criteria:

• pregnancy;
• current antihistamine therapy;
• subjects that do not give consent to the study

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
A; Subjects with mild (S1) reaction to peach fruit
B; Subjects with severe reaction to peach fruit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of diagnostic efficacy of PHADIA IMMUNO-CAP with the peach recombinant allergens Pru p 3, 1 and 4 as compared to peach IMMUNO-CAP in the identification of peach allergic subjects at major risk of anaphylaxis	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluate whether the above recombinants allergens could help identifying subjects with severe reaction to other fruits	1 year

Collaborators and Investigators

• Sponsor: Niguarda Hospital
• Investigators: Principal Investigator: Elide A Patorello, MD, Niguarda Hospital

Publications and helpful links

General Publications

• Pastorello EA, Farioli L, Pravettoni V, Scibilia J, Mascheri A, Borgonovo L, Piantanida M, Primavesi L, Stafylaraki C, Pasqualetti S, Schroeder J, Nichelatti M, Marocchi A. Pru p 3-sensitised Italian peach-allergic patients are less likely to develop severe symptoms when also presenting IgE antibodies to Pru p 1 and Pru p 4. Int Arch Allergy Immunol. 2011;156(4):362-72. doi: 10.1159/000324440. Epub 2011 Aug 9.
• Mascheri A, Farioli L, Pravettoni V, Piantanida M, Stafylaraki C, Scibilia J, Mirone C, Preziosi D, Nichelatti M, Pastorello EA. Hypersensitivity to Tomato (Lycopersicon esculentum) in Peach-Allergic Patients: rPrup 3 and rPrup 1 Are Predictive of Symptom Severity. J Investig Allergol Clin Immunol. 2015;25(3):183-9.

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: July 14, 2008
• First Submitted That Met QC Criteria: July 14, 2008
• First Posted (Estimate): July 15, 2008

Study Record Updates

• Last Update Posted (Estimate): February 22, 2012
• Last Update Submitted That Met QC Criteria: February 20, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: LTP; allergy, peach, birch; recombinants allergens diagnosis; OAS; systemic reactions; subjects with severe reaction to other fruits
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity
• Other Study ID Numbers: Peach allergy