Tailoring allergy shots to a child's dust mite allergy profile
A Multicenter Registry Study Examining the Efficacy of Specific Immunotherapy Guided by Component-Resolved Diagnosis for Dust Mite Allergens in Chinese Pediatric Patients With Rhinitis and/or Asthma（EXPLORER STUDY）
This project will see if matching allergy shots to each child's specific dust mite proteins helps children ages 5–17 with dust mite nasal allergies (and well-controlled asthma) have fewer symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 5 Years to 18 Years |
| Sex | All |
| Sponsor | The Children's Hospital of Zhejiang University School of Medicine Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT07452380 on ClinicalTrials.gov |
What this trial studies
Investigators will use component-resolved diagnosis (blood tests that identify which specific dust mite proteins trigger IgE) to define each child's allergen profile. Children aged 5–17 who are already receiving dual-mite subcutaneous immunotherapy (SCIT) will be followed prospectively while their symptoms, medication use, and immune markers are recorded. The study is observational and does not change standard treatment; it compares outcomes across different component-sensitization patterns. Data will be analyzed to see whether particular component profiles predict better or worse responses to SCIT.
Who should consider this trial
Good fit: Children aged 5–17 with allergic rhinitis caused by Dermatophagoides pteronyssinus and/or D. farinae, with serum specific IgE ≥ 0.70 kU/L who undergo component testing and who are receiving dual-mite SCIT (with any asthma required to be well-controlled) are the intended participants.
Not a fit: Children whose allergies are not due to D. pteronyssinus or D. farinae, who are not receiving dual-mite SCIT, who have uncontrolled asthma, or who cannot complete component testing are unlikely to benefit from this matching approach.
Why it matters
Potential benefit: If successful, clinicians could personalize allergy shots to the exact mite proteins a child reacts to, potentially reducing symptoms and improving long-term control.
How similar studies have performed: Previous studies using component-resolved diagnosis to guide immunotherapy have shown promising signals in adults and small pediatric series, but large definitive pediatric outcome studies remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: -(1) Age: 5 years ≤ age \< 18 years; (2) 1) Allergic rhinitis caused by Dermatophagoides pteronyssinus and/or Dermatophagoides farinae; 2) Or serum specific IgE ≥ 0.70 (kU/L) (for D. pteronyssinus and/or D. farinae); (3) Children meeting criteria (2) must undergo allergen component testing; (4) If accompanied by bronchial asthma, asthma must be diagnosed according to the Guidelines for the Diagnosis and Prevention of Childhood Bronchial Asthma (2025 edition) and the patient's asthma symptoms must be confirmed as well-controlled. (5) Receiving treatment with dual-mite (Dermatophagoides pteronyssinus and farinae) subcutaneous immunotherapy (SCIT). Exclusion Criteria: * (1) Participants and/or their parents/legal guardians are judged by the investigator to be unable to fully understand the study requirements, or to adhere to long-term treatment and identify adverse reactions (including but not limited to conditions such as cognitive impairment or mental illness); (2) Children with severe or uncontrolled asthma (FEV1 \< 70% of predicted value) or with irreversible airflow obstruction; (3) Children using beta-blockers or angiotensin-converting enzyme inhibitors (ACEI); (4) Children with severe autoimmune diseases or immunodeficiencies, including AIDS, inflammatory bowel disease, etc., as well as those currently using immunosuppressants; (5) Children with severe cardiovascular diseases or malignant tumors; (6) Children with incomplete clinical data.
Where this trial is running
Hangzhou, Zhejiang
- The Children's Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Yujia Xiao, PhD
- Email: 6195007@zju.edu.cn
- Phone: 86+13397813805
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.