Recombinant Tropomyosin- and Hemocyanin-Specific IgE in Children With Suspected Shrimp Allergy

Diagnostic Value of Recombinant Tropomyosin- and Hemocyanin-Specific IgE for the Diagnosis of IgE-Mediated Shrimp Allergy in Children in Vietnam

This study will evaluate whether blood tests that measure IgE antibodies to two shrimp proteins, tropomyosin and hemocyanin, can help diagnose shrimp allergy in children. Children with suspected IgE-mediated shrimp allergy will undergo oral food challenge, skin prick testing, and blood sampling. Oral food challenge results will be used as the reference standard to determine whether these tests can accurately identify true shrimp allergy and help improve diagnosis in clinical practice.

Study Overview

• Status: Not yet recruiting
• Conditions: Food Hypersensitivity; Shellfish Allergy
• Intervention / Treatment: Diagnostic test: Oral Food Challenge (OFC); Diagnostic test: Skin Prick Test; Diagnostic test: Recombinant Tropomyosin- and Hemocyanin-Specific IgE Measurement

Detailed Description

Shrimp allergy is an important cause of IgE-mediated food allergy in children, and diagnosis remains challenging because conventional tests may not reliably distinguish true clinical allergy from sensitization or cross-reactivity. Oral food challenge (OFC) remains the reference standard, but it is time-consuming, resource-intensive, and may trigger significant allergic reactions.

This interventional diagnostic study will enroll children with suspected IgE-mediated shrimp allergy. Participants will undergo OFC according to the study protocol, together with skin prick testing and blood sampling for measurement of specific IgE to recombinant tropomyosin and hemocyanin. To standardize the diagnostic procedure, OFC will be performed using black tiger shrimp (Penaeus monodon) in all participants. Additional OFCs using other shrimp species may be performed when the clinical history suggests reactions to a different shrimp species. OFC results will be used to classify participants as shrimp allergic or shrimp tolerant.

The study will estimate the proportion of true shrimp allergy among children with suspected shrimp allergy and evaluate the diagnostic performance of recombinant tropomyosin- and hemocyanin-specific IgE, alone and in combination with clinical history and skin prick test results. The findings are expected to support more accurate molecular diagnosis of shrimp allergy in children and help optimize the indication for OFC in clinical practice in Vietnam.

• Study Type: Interventional
• Enrollment (Estimated): 129
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ngoc Thi Nguyen, MD; Phone Number: +84 908 876 976; Email: ntngoc.ncs25@ump.edu.vn

Study Locations

• Vietnam
  • Ho Chi Minh City, Vietnam
    • Children's Hospital 1
    • Contact: Ngoc Thi Nguyen, MD; Phone Number: +84 908 876 976; Email: ntngoc.ncs25@ump.edu.vn
    • Principal Investigator: Ngoc Thi Nguyen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Children aged 1 to 16 years.
• Evaluated at the Allergy Unit of Children's Hospital 1.
• Clinical history suggestive of IgE-mediated shrimp allergy based on EAACI 2023 criteria, including at least 1 typical allergic symptom (urticaria, angioedema, vomiting, abdominal pain, diarrhea, cough, wheezing, dyspnea, or hypotension), symptom onset within 2 hours after shrimp ingestion, and recurrence on at least 2 separate exposures.
• Parent or legal guardian able to provide written informed consent; child assent obtained when appropriate.

Exclusion Criteria:

• Acute illness at the time of enrollment or challenge, including acute respiratory infection, acute gastrointestinal infection, or acute asthma exacerbation.
• Severe chronic disease, including malignancy, severe liver or kidney disease, primary immunodeficiency, or significant heart disease affecting hemodynamic status.
• Mental or behavioral disorder that prevents completion of study procedures.
• Use of immunosuppressive medication (oral corticosteroids, cytotoxic drugs, or biologic agents) within 4 weeks before enrollment, or intravenous immunoglobulin within the previous 3 months.

Exclusion Criteria:

• Acute illness at the time of enrollment or challenge, including acute respiratory infection, acute gastrointestinal infection, or acute asthma exacerbation; participants may be rescheduled after recovery.
• Severe chronic disease, including malignancy, severe liver or kidney disease, primary immunodeficiency, or significant heart disease affecting hemodynamic status.
• Mental or behavioral disorder that prevents completion of study procedures.
• Use of immunosuppressive medication (oral corticosteroids, cytotoxic drugs, or biologic agents) within 4 weeks before enrollment, or intravenous immunoglobulin within the previous 3 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Children With Suspected IgE-Mediated Shrimp Allergy; Children with suspected IgE-mediated shrimp allergy who undergo the study procedures, including oral food challenge, skin prick testing, and blood sampling for measurement of recombinant tropomyosin- and hemocyanin-specific IgE. Oral food challenge will be standardized using black tiger shrimp (Penaeus monodon), with additional challenge using other shrimp species when clinically indicated.

Diagnostic test: Oral Food Challenge (OFC); Oral food challenge with shrimp performed according to the study protocol to confirm or exclude IgE-mediated shrimp allergy in children with suspected shrimp allergy. To standardize the challenge material, black tiger shrimp (Penaeus monodon) will be used in all participants. Additional oral food challenges using other shrimp species may be performed when the clinical history suggests reactions to a different shrimp species. The oral food challenge result serves as the reference standard for diagnostic evaluation in this study.; Diagnostic test: Skin Prick Test; Skin prick testing performed as part of the diagnostic evaluation in children with suspected IgE-mediated shrimp allergy.; Diagnostic test: Recombinant Tropomyosin- and Hemocyanin-Specific IgE Measurement; Blood testing to measure specific IgE to recombinant tropomyosin and hemocyanin as part of the diagnostic evaluation of suspected shrimp allergy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral Food Challenge-Confirmed IgE-Mediated Shrimp Allergy	Participants will be classified as having true IgE-mediated shrimp allergy if the oral food challenge is positive according to the study protocol. A negative oral food challenge indicates shrimp tolerance. Oral food challenge results will be used as the reference standard for subsequent diagnostic performance analyses.	At the time of the oral food challenge during the baseline diagnostic evaluation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Accuracy of Recombinant Tropomyosin-Specific IgE for Oral Food Challenge-Confirmed Shrimp Allergy	Diagnostic performance of recombinant tropomyosin-specific IgE will be evaluated against oral food challenge results, including receiver operating characteristic analysis, area under the curve, optimal cutoff, sensitivity, specificity, positive predictive value, and negative predictive value.	During the baseline diagnostic evaluation
Diagnostic Accuracy of Recombinant Hemocyanin-Specific IgE for Oral Food Challenge-Confirmed Shrimp Allergy	Diagnostic performance of recombinant hemocyanin-specific IgE will be evaluated against oral food challenge results, including receiver operating characteristic analysis, area under the curve, optimal cutoff, sensitivity, specificity, positive predictive value, and negative predictive value.	During the baseline diagnostic evaluation
Diagnostic Accuracy of a Combined Model Incorporating Recombinant Tropomyosin-Specific IgE, Recombinant Hemocyanin-Specific IgE, Clinical History, and Skin Prick Test	A combined diagnostic model using recombinant tropomyosin-specific IgE, recombinant hemocyanin-specific IgE, clinical history suggestive of shrimp allergy, and skin prick test results will be evaluated against oral food challenge results. Model performance will include receiver operating characteristic analysis and area under the curve.	During the baseline diagnostic evaluation

Collaborators and Investigators

• Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
• Collaborators: Children's Hospital Number 1, Ho Chi Minh City, Vietnam
• Investigators: Principal Investigator: Tu HK Trinh, MD, PhD, University of Medicine and Pharmacy at Ho Chi Minh City

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: March 24, 2026
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Children; Skin Prick Test; Oral Food Challenge; Specific IgE; Food Hypersensitivity; Shrimp Allergy; Tropomyosin; Hemocyanin; Recombinant Allergen; Shellfish Allergy
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Shellfish Hypersensitivity; Food Hypersensitivity; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Immunologic Techniques; Immunologic Tests; Skin Tests; Patch Tests
• Other Study ID Numbers: UMP-SHRIMP-IgE-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No