Safety of Lymph Node Injection for Allergen Immunotherapy

February 5, 2016 updated by: Amber Patterson

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 15-24 years
  • Bothersome nasal, ocular, and/or respiratory symptoms correlating with grass pollen season (summer)
  • Grass pollen allergic (+ skin prick test [wheal ≥ 3 mm larger than negative control] or specific IgE [minimum 0.35 kU/L] to grass pollen [Timothy or a northern pasture grass mix containing Timothy])
  • Informed consent obtained and signed
  • Informed assent (as appropriate) obtained and signed
  • Understanding of study procedures
  • Ability to comply with study procedures for the entire length of the study
  • For inclusion in observational group (arm 3), must have initiated SCIT containing grass pollen 12 - 18 months prior to grass pollen season 2014 (ex. started SCIT any time Dec 2012 - May 2013). This group was included for comparison between traditional IT and ILIT, and these subjects will continue SCIT during this study. Since patients undergoing SCIT may not see clinical response to therapy until 12 months, we selected this time point to better compare with the more rapid immunologic and clinical changes expected with ILIT.

Exclusion Criteria:

  • Significant year-round allergy symptoms and year-round symptoms without worsening during grass pollen season (summer). (Exception: intermittent year-round symptoms with significant worsening during summer is acceptable for inclusion).
  • Blood donation or surgery within the previous 30 days of baseline/enrollment, visit #1.
  • Use of investigational drugs within the previous 90 days
  • Pregnancy or nursing
  • Mastocytosis
  • Significant cardiovascular, hepatic, renal, autoimmune, hematological, or active infectious disease
  • History of malignancy, hypertension, use of immunosuppressive agents, beta-blockers, ACE inhibitors, or tricyclic antidepressants
  • Pulmonary disease, including moderate to severe, perennial asthma (FEV1 < 80% predicted) and perennial use of inhaled corticosteroids (exception: seasonal allergic asthma will not be excluded)
  • Previous IT (exception: those in observational arm currently on grass SCIT).
  • No readily accessible inguinal lymph nodes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Grass pollen extract injection
Grass pollen extract injected intralymphatically q 4 weeks x 3
Biological: Grass pollen extract
Grass pollen extract injected intralymphatically q 4 weeks x 3
Placebo Comparator: Placebo injection
Normal saline injected intralymphatically q 4 weeks x 3
Other: Placebo injection
Normal saline injected intralymphatically q 4 weeks x 3
Other Names:
  • Normal saline
No Intervention: Observational group
Subjects already receiving traditional subcutaneous allergy immunotherapy for grass pollen, being observed for safety of their subcutaneous injections. Not receiving active intervention during this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Severe Adverse Events as a Measure of Safety and Tolerability
Time Frame: Final data regarding adverse events will be assessed one week after the final injection (approximately 3 months after initial injection).
Final data regarding adverse events will be assessed one week after the final injection (approximately 3 months after initial injection).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amber Patterson

Collaborators

Nationwide Children's Hospital

Investigators

  • Principal Investigator: Amber M Patterson, MD, Nationwide Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

October 29, 2013

First Submitted That Met QC Criteria

November 6, 2013

First Posted (Estimate)

November 13, 2013

Study Record Updates

Last Update Posted (Estimate)

February 9, 2016

Last Update Submitted That Met QC Criteria

February 5, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB13-00409

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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