Safety of Lymph Node Injection for Allergen Immunotherapy

Allergic Rhinitis Clinical Trial

Official title: Phase I Study of Allergen-Specific Intralymphatic Immunotherapy in the United States

Status Active, not recruiting

Clinical Trial Summary

The purpose of this study is to determine safety of allergy immunotherapy lymph node injections for grass pollen allergies.

Clinical Trial Description

Specific immunotherapy (SIT) has been used in the treatment of allergic disease for over one hundred years. SIT for environmental allergies consists of allergen extracts that have been traditionally administered by subcutaneous or sublingual routes to both children and adults. In the United States, subcutaneous immunotherapy (SCIT) is currently the only FDA-approved route of administration for allergenic extracts. In recent years, a novel method of administering allergen immunotherapy, intralymphatic immunotherapy (ILIT), has been developed, which has shown to be safer, more efficacious, and less painful than traditional SCIT. ILIT can dramatically decrease treatment time from 3 - 5 years to 8 weeks. It has only been studied in European adults. The aim of this project is to study efficacy and safety of intralymphatic immunotherapy in adolescents and young adults with allergic rhinoconjunctivitis, using currently available allergen extracts. Patients with clinical history suspicious for rhinitis with or without conjunctivitis, correlating with positive allergy skin and/or blood tests to grass pollen, will be randomized to either placebo (normal saline) or treatment (Center-Al grass pollen extract) arms. A total of 3 injections over eight weeks will be administered intralymphatically. A third arm will include an observational group of grass-allergic subjects already receiving SCIT for 1 year. Primary outcome will be comparison of a safety score between arms 1 and 2. We will follow adverse events, as well as serum markers for Th2 and Th1 phenotypes, and objective respiratory measures (spirometry and FeNO) in those with asthma. Visits will occur at baseline for screening/enrollment, on day 0/week4/week 8 for injections (injection visit for arms 1 and 2 only), and for follow-up at 12 weeks and near end of grass pollen season. A substudy will evaluate participants one-year after completing ILIT injections by obtaining repeat serum biomarker levels and interval change in medical history. Results could help in dramatically decreasing treatment time, as well as increasing safety of allergen immunotherapy. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis

• NCT number: NCT01982474
• Study type: Interventional
• Source: Nationwide Children's Hospital
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: October 2013
• Completion date: December 2016