Allergic RhinitisPhase 1NCT01982474
Safety of Lymph Node Injection for Allergen Immunotherapy
A Phase 1 study testing Grass pollen extract in people with Allergic Rhinitis, run by Amber Patterson at 1 site in United States.
Trial summary
The purpose of this study is to determine safety of allergy immunotherapy lymph node injections for grass pollen allergies. Read more about this study
- Who is it for?
- Ages 15 to 24 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Grass pollen extract
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Dec 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: 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.
Read the 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.
- Conditions
- Allergic Rhinitis
- Being tested
- Grass pollen extract, Placebo injection
- Keywords
- allergic rhinitis
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grass pollen extractBiological
Grass pollen extract injected intralymphatically q 4 weeks x 3
Placebo injectionOther
Also called Normal saline
Normal saline injected intralymphatically q 4 weeks x 3
| Study group | Role | What they receive |
|---|---|---|
| Grass pollen extract injection | Experimental | Grass pollen extract injected intralymphatically q 4 weeks x 3 Receives: Biological: Grass pollen extract |
| Placebo injection | Placebo comparator | Normal saline injected intralymphatically q 4 weeks x 3 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Severe Adverse Events as a Measure of Safety and Tolerability
Measured: Final data regarding adverse events will be assessed one week after the final injection (approximately 3 months after initial injection).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amber Patterson
- Sponsor type
- University, hospital or other
- Collaborators
- Nationwide Children's Hospital
- Responsible party
- Sponsor-investigator, Amber Patterson, Nationwide Children's Hospital
- Investigators
- Amber M Patterson, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01982474
- Sponsor's protocol ID
- IRB13-00409
- Status last verified
- Feb 2016
- First submitted
- 29 Oct 2013
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22464647Senti 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.
PubMed 19001265Hylander 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.
PubMed 23374268Patterson 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.
PubMed 26706294
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Allergen-Specific Intralymphatic Immunotherapy in the United States
- ClinicalTrials.gov ID
- NCT01982474
- Acronym / sponsor ID
- IRB13-00409
- Conditions
- Allergic Rhinitis
- Keywords
- allergic rhinitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Amber PattersonUniversity, hospital or other
- Collaborators
- Nationwide Children's Hospital
- Study start
- Oct 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 13 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Grass pollen extract injection | Experimental | Biological: Grass pollen extractGrass pollen extract injected intralymphatically q 4 weeks x 3 |
| Placebo injection | Placebo comparator | Other: Placebo injectionNormal saline injected intralymphatically q 4 weeks x 3 |
| 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. |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grass pollen extractGrass pollen extract injected intralymphatically q 4 weeks x 3 | Biological | Grass pollen extract injection |
| Placebo injectionAlso: Normal salineNormal saline injected intralymphatically q 4 weeks x 3 | Other | Placebo injection |
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2016.
- Background: PubMed 22464647Senti 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.
- Background: PubMed 19001265Senti 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.
- Background: PubMed 23374268Hylander 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.
- Derived from this study: PubMed 26706294Patterson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amber M Patterson, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Grass pollen extract in people with Allergic Rhinitis, run by Amber Patterson at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01982474, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2016.