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Safety of Lymph Node Injection for Allergen Immunotherapy

Primary Purpose

Allergic Rhinitis

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Grass pollen extract

Placebo injection

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring allergic rhinitis

Eligibility Criteria

15 Years - 24 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Nationwide Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Grass pollen extract injection

Placebo injection

Observational group

Arm Description

Grass pollen extract injected intralymphatically q 4 weeks x 3

Normal saline injected intralymphatically q 4 weeks x 3

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01982474

First Posted

October 29, 2013

Last Updated

February 5, 2016

Sponsor

Amber Patterson

Collaborators

Nationwide Children's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01982474

Brief Title

Safety of Lymph Node Injection for Allergen Immunotherapy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Unknown status

Study Start Date

October 2013 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Amber Patterson

Collaborators

Nationwide Children's Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Rhinitis

Keywords

allergic rhinitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Grass pollen extract injection

Arm Type

Experimental

Arm Description

Grass pollen extract injected intralymphatically q 4 weeks x 3

Arm Title

Placebo injection

Arm Type

Placebo Comparator

Arm Description

Normal saline injected intralymphatically q 4 weeks x 3

Arm Title

Observational group

Arm Type

No Intervention

Arm Description

Intervention Type

Biological

Intervention Name(s)

Grass pollen extract

Intervention Description

Grass pollen extract injected intralymphatically q 4 weeks x 3

Intervention Type

Other

Intervention Name(s)

Placebo injection

Other Intervention Name(s)

Normal saline

Intervention Description

Normal saline injected intralymphatically q 4 weeks x 3

Primary Outcome Measure Information:

Title

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).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

24 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amber M Patterson, MD

Organizational Affiliation

Nationwide Children's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Nationwide Children's Hospital

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43205

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

22464647

Citation

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.

Results Reference

background

PubMed Identifier

19001265

Citation

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.

Results Reference

background

PubMed Identifier

23374268

Citation

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.

Results Reference

background

PubMed Identifier

26706294

Citation

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.

Results Reference

derived

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Safety of Lymph Node Injection for Allergen Immunotherapy

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