Safety of Lymph Node Injection for Allergen Immunotherapy



Status:Active, not recruiting
Conditions:Allergy
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:15 - 24
Updated:4/21/2016
Start Date:October 2013
End Date:December 2016

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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.

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.

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
We found this trial at
1
site
700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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