Novel Treatment for Patients With Peanut Allergy: Intralymphatic Immunotherapy

Food Allergy Peanut Clinical Trial

Official title:

Intra-lymphatic Immunotherapy for the Management of Peanut Allergy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04200989
• Other study ID #: IRB-19-7380
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: March 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2021
• Source: Scripps Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Use of three intralymphatic injections of peanut allergen one month apart to induce tolerance to peanut in peanut allergic people.

Description:

Eligible subject undergo a baseline blinded oral peanut challenge. Then the peanut ILIT as described above. Pretreatment with antihistamines, leukotriene modifier and albuterol before each treatment. Following the three ILIT peanut injections a repeat blinded oral peanut challenge is performed. Blood is drawn at each of the 5 study visits for a variety of tests trying to elucidate the mechanism(s) of the induction of tolerance to peanut.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 80 Years

Eligibility

Inclusion Criteria:

History of peanut allergy Positive prick skin tests or invitro IgE to peanut Positive blinded oral peanut challenge. - Exclusion Criteria: History of

• life threatening anaphylaxis to peanut Uncontrolled asthma

Related Conditions & MeSH terms

• Food Allergy Peanut
• Food Hypersensitivity
• Hypersensitivity
• Peanut Hypersensitivity

Intervention

Biological:
• Peanut allergen
Intralymphatic immunotherapy injections.

Locations

Country	Name	City	State
United States	Scripps Clinic	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Scripps Health	The Scripps Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (3)

Hylander T, Latif L, Petersson-Westin U, Cardell LO. Intralymphatic allergen-specific immunotherapy: an effective and safe alternative treatment route for pollen-induced allergic rhinitis. J Allergy Clin Immunol. 2013 Feb;131(2):412-20. doi: 10.1016/j.jaci.2012.10.056. — View Citation

Lee SP, Choi SJ, Joe E, Lee SM, Lee MW, Shim JW, Kim YJ, Kyung SY, Park JW, Jeong SH, Jung JH. A Pilot Study of Intralymphatic Immunotherapy for House Dust Mite, Cat, and Dog Allergies. Allergy Asthma Immunol Res. 2017 May;9(3):272-277. doi: 10.4168/aair.2017.9.3.272. — View Citation

Senti G, Crameri R, Kuster D, Johansen P, Martinez-Gomez JM, Graf N, Steiner M, Hothorn LA, Grönlund H, Tivig C, Zaleska A, Soyer O, van Hage M, Akdis CA, Akdis M, Rose H, Kündig TM. Intralymphatic immunotherapy for cat allergy induces tolerance after only 3 injections. J Allergy Clin Immunol. 2012 May;129(5):1290-6. doi: 10.1016/j.jaci.2012.02.026. Epub 2012 Mar 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peanut tolerance	Increase in amount (mg - grams) of peanut ingested without reaction from baseline to one month post ILIT	4 months