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A randomized, double-blind, placebo-controlled, multi-centre study to assess the safety of HAL-MPE1 subcutaneous immunotherapy in adolescent subjects with peanut allergy

University of North Carolina at Chapel Hill


Description

The purpose of this study is to assess the safety and tolerability of the use of an investigational drug, HAL-MPE1. This drug may benefit individuals with peanut allergy in the future. Participation in this study is not expected to benefit participants. This drug is injected into the back of the arm on a weekly basis for approximately 20 weeks. Subjects will be observed in the research unit at UNC for 4 hours after injections.


Keywords:

Allergy, Pediatrics


Category:

Drug or Biologic
Phase:1

Qualifications

 


Age
5 - 11 years


Gender
Any


Study Population

Children aged 5-11 with peanut allergy


Investigator

Edwin Kim
Clinical Assistant Professor
Medicine-UNCP A Allergy and Immunology

For questions, contact:

Lauren Herlihy
lekoch@email.unc.edu
(919) 962-4406
Visit Website

Recruitment Period End

December 31, 2018

Location

Primary Location
Clinical & Translational Research Center

Study Qualifications

Gender Any

Age Range 5 - 11 years

Participant qualification(s) 1. Signed informed consent/assent 2. Male or female subjects aged 5-11 years 3. A well-documented medical history of systemic reactions after ingestion of peanut 4. Positive serum specific anti-peanut (>5.0 kU/L) and Ara h 2 IgE-test (>2.0 kU/L) 5. Skin prick test (SPT) to peanut ≥3 mm compared to negative control within the last 2 years 6. FEV1>80% predicted (adults and adolescents) or PEF>80% predicted (children) 7. Negative pregnancy test at screening for females of childbearing potential

Not eligible if: 1. Subjects with a history of severe anaphylaxis to peanut 2. Known allergy or hypersensitivity to an excipient in the study drug or placebo 3. Poorly controlled asthma 4. Participation in any interventional study with peanut immunotherapy in the last year 5. Any specific immunotherapy (SCIT, SLIT or OIT) during the study period 6. Severe immune disorders (including autoimmune diseases) and/or diseases requiring immunosuppressive drugs 7. Active malignancies or any malignant disease within the past 5 years 8. Severe (uncontrolled) diseases 9. Diseases with a contraindication for the use of epinephrine (e.g. hyperthyroidism, glaucoma) 10. Treatment with beta-blockers or ACE inhibitors 11. For female adolescents and adults of childbearing potential: Pregnancy (test performed at screening), lactation or inadequate contraceptive measures for women of child-bearing age 12. Lack or expected lack of cooperation or compliance

Number of Visits

    » 17-23 In person visit(s)

    1 Screening, 15-20 dosing visits, 2 follow up visits

    » 3 Remote visit(s)

    3 phone follow up calls

Participation Period

approximately 6 months

Compensation

Up to $1800, paid per visit

By clicking I am interested, your contact information will be sent to the researcher/study coordinator for this study. The coordinator will respond by email with additional information on how to proceed.