Safety of Lymph Node Injection for Allergen Immunotherapy

NCT01982474 | Unknown Phase 1 DMC

• 1 other identifier: IRB13-00409
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Allergic Rhinitis

Keywords

allergic rhinitis

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Severe Adverse Events as a Measure of Safety and Tolerability

  Final data regarding adverse events will be assessed one week after the final injection (approximately 3 months after initial injection).

Study Arms (3)

Grass pollen extract injection

EXPERIMENTAL

Grass pollen extract injected intralymphatically q 4 weeks x 3

Biological: Grass pollen extract

Placebo injection

PLACEBO COMPARATOR

Normal saline injected intralymphatically q 4 weeks x 3

Other: Placebo injection

Observational group

NO INTERVENTION

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.

Interventions

Grass pollen extract BIOLOGICAL

Grass pollen extract injected intralymphatically q 4 weeks x 3

Grass pollen extract injection

Placebo injection OTHER

Normal saline injected intralymphatically q 4 weeks x 3

Also known as: Normal saline

Placebo injection

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amber Patterson: lead
• Nationwide Children's Hospital: collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (4)

• Senti G, Crameri R, Kuster D, Johansen P, Martinez-Gomez JM, Graf N, Steiner M, Hothorn LA, Gronlund H, Tivig C, Zaleska A, Soyer O, van Hage M, Akdis CA, Akdis M, Rose H, Kundig 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.

  PMID: 22464647 BACKGROUND

• Senti G, Prinz Vavricka BM, Erdmann I, Diaz MI, Markus R, McCormack SJ, Simard JJ, Wuthrich B, Crameri R, Graf N, Johansen P, Kundig TM. Intralymphatic allergen administration renders specific immunotherapy faster and safer: a randomized controlled trial. Proc Natl Acad Sci U S A. 2008 Nov 18;105(46):17908-12. doi: 10.1073/pnas.0803725105. Epub 2008 Nov 10.

  PMID: 19001265 BACKGROUND

• 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.

  PMID: 23374268 BACKGROUND

• Patterson AM, Bonny AE, Shiels WE 2nd, Erwin EA. Three-injection intralymphatic immunotherapy in adolescents and young adults with grass pollen rhinoconjunctivitis. Ann Allergy Asthma Immunol. 2016 Feb;116(2):168-70. doi: 10.1016/j.anai.2015.11.010. Epub 2015 Dec 17. No abstract available.

  PMID: 26706294 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

grass pollen extract, alum-adsorbed; Saline Solution

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Amber M Patterson, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 29, 2013
• First Posted: November 13, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 9, 2016

Record last verified: 2016-02

Locations

US (1)