AllergyNCT00429429
Immunotherapy for Peanut Allergy
A study testing Sublingual immunotherapy in people with Allergy, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Currently, when a food allergy is diagnosed, the "standard of care" is strict avoidance of the allergic food and ready access to self-injectable epinephrine. Yet, accidental ingestions do occur. Unfortunately, for a ubiquitous food such as peanut, the possibility of an inadvertent ingestion is great. Read more about this study
- Who is it for?
- Ages 6 to 35 years
- Conditions the study is for
- Allergy
- What is being tested?
- Sublingual immunotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to May 2011
- Phase
- Interventional
- 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 6 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subjects between 6 and 35 years of age
- Diagnosed with peanut allergy by positive prick skin test, CAP FEIA of 15 Ku/L or greater
- History of significant clinical symptoms within one hour after ingestion of peanuts
- Family's compliance with all study visits
Who cannot join
- Subjects with medical history preventing a BDPCFC to peanut
- Subjects unable to cooperate with challenge procedure
- Subjects unable to be reached by telephone for follow-up
- Subjects with a history of severe anaphylaxis to peanut
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina
Chapel Hill, North Carolina, 27599
About this study
Currently, when a food allergy is diagnosed, the "standard of care" is strict avoidance of the allergic food and ready access to self-injectable epinephrine. Yet, accidental ingestions do occur. Unfortunately, for a ubiquitous food such as peanut, the possibility of an inadvertent ingestion is great. It is estimated that over 50% of individuals who are allergic to peanuts will have an accidental reaction to peanuts over a 2-year period. The purpose of this study is to determine if peanut sublingual immunotherapy (SLIT) reduces the number and/or symptoms of accidental peanut ingestion in peanut allergic subjects. We would anticipate that the subjects on the peanut SLIT protocol would experience few adverse effects with accidental peanut ingestion over the course of the two years of SLIT. The primary endpoint to evaluate the effectiveness of SLIT will be a negative DBPCFC to peanuts (8 grams) at the completion of the two years of the study.
Read the detailed description
Peanut allergy is one of the most serious of the immediate hypersensitivity reactions to foods in terms of persistence and severity of the reaction and appears to be a growing problem. Allergen-specific immunotherapy (IT) is currently being examined as a treatment option because of the persistence of this hypersensitivity reaction and the lack of effective treatment. An understanding of the molecular mechanisms of peanut-specific IT is vital to ensure the eventual, successful treatment of peanut-allergic patients.
The goal of this proposal is to develop peanut immunotherapy (IT) for patients with peanut allergic reactions. This innovative application is designed to utilize the extensive knowledge of the allergens involved in peanut hypersensitivity to devise an immunotherapeutic approach that would lower the risk of anaphylactic reactions and would down regulate peanut-specific T cells in peanut-allergic patients. Previous attempts to utilize peanut-specific immunotherapy have been unsuccessful primarily because of the severe side effects of therapy.
The specific aim of the study is to desensitize/tolerize peanut-allergic subjects with peanut allergen-specific, sublingual immunotherapy (SLIT) and begin to determine the molecular mechanism of the peanut-specific T-cell response during SLIT.
The hypothesis is that peanut SLIT will desensitize patients with peanut allergic reactions by the induction of peanut specific regulatory T cells resulting in immune modulation of the peanut allergic reaction.
- Conditions
- Allergy
- Being tested
- Sublingual immunotherapy
- Keywords
- Peanut allergy
- Medical subject headings
- Hypersensitivity, Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sublingual immunotherapyProcedure or surgery
Also called Peanut protein solution
Drops of peanut protein placed and held under the tongue for a specific time before swallowed.
| Study group | Role | What they receive |
|---|---|---|
| Peanut protein solution | Experimental | Subjects receiving the peanut sublingual peanut protein drops. Sublingual Immunotherapy. Receives: Procedure: Sublingual immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
A negative double-blind placebo controlled food challenge at the completion the two years of the study.
Measured: When IgE level drops to less than or equal to 2 ku/L
Secondary outcomes (1)
A change in the cytokine level between the baseline and each selected time point during the two years of the study.
Measured: Drop in cytokine level
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2007 (estimated)
- Study startApr 2006
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for AllergyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wesley Burks, MD, University of North Carolina, Chapel Hill
- Investigators
- Wesley Burks, MD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00429429
- Sponsor's protocol ID
- 1R21AT002557-02
- Status last verified
- Jun 2016
- First submitted
- 30 Jan 2007
- Last updated
- 20 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Bock SA, Munoz-Furlong A, Sampson HA. Fatalities due to anaphylactic reactions to foods. J Allergy Clin Immunol. 2001 Jan;107(1):191-3. doi: 10.1067/mai.2001.112031.
PubMed 11150011Sicherer SH, Munoz-Furlong A, Burks AW, Sampson HA. Prevalence of peanut and tree nut allergy in the US determined by a random digit dial telephone survey. J Allergy Clin Immunol. 1999 Apr;103(4):559-62. doi: 10.1016/s0091-6749(99)70224-1.
PubMed 10200001Sicherer SH, Munoz-Furlong A, Sampson HA. Prevalence of peanut and tree nut allergy in the United States determined by means of a random digit dial telephone survey: a 5-year follow-up study. J Allergy Clin Immunol. 2003 Dec;112(6):1203-7. doi: 10.1016/s0091-6749(03)02026-8.
PubMed 14657884Oppenheimer JJ, Nelson HS, Bock SA, Christensen F, Leung DY. Treatment of peanut allergy with rush immunotherapy. J Allergy Clin Immunol. 1992 Aug;90(2):256-62. doi: 10.1016/0091-6749(92)90080-l.
PubMed 1500630Wilson DR, Torres LI, Durham SR. Sublingual immunotherapy for allergic rhinitis. Cochrane Database Syst Rev. 2003;(2):CD002893. doi: 10.1002/14651858.CD002893.
PubMed 12804442Sloan AE, Powers ME. A perspective on popular perceptions of adverse reactions to foods. J Allergy Clin Immunol. 1986 Jul;78(1 Pt 2):127-33. doi: 10.1016/0091-6749(86)90002-3. No abstract available.
PubMed 3722639Jansen JJ, Kardinaal AF, Huijbers G, Vlieg-Boerstra BJ, Martens BP, Ockhuizen T. Prevalence of food allergy and intolerance in the adult Dutch population. J Allergy Clin Immunol. 1994 Feb;93(2):446-56. doi: 10.1016/0091-6749(94)90353-0.
PubMed 8120272Sampson HA. Food allergy. J Allergy Clin Immunol. 1989 Dec;84(6 Pt 2):1062-7. doi: 10.1016/0091-6749(89)90154-1. No abstract available.
PubMed 2600342Bock SA, Atkins FM. Patterns of food hypersensitivity during sixteen years of double-blind, placebo-controlled food challenges. J Pediatr. 1990 Oct;117(4):561-7. doi: 10.1016/s0022-3476(05)80689-4.
PubMed 2213379Valentine MD, Schuberth KC, Kagey-Sobotka A, Graft DF, Kwiterovich KA, Szklo M, Lichtenstein LM. The value of immunotherapy with venom in children with allergy to insect stings. N Engl J Med. 1990 Dec 6;323(23):1601-3. doi: 10.1056/NEJM199012063232305.
PubMed 2098016Leung DY, Sampson HA, Yunginger JW, Burks AW Jr, Schneider LC, Wortel CH, Davis FM, Hyun JD, Shanahan WR Jr; Avon Longitudinal Study of Parents and Children Study Team. Effect of anti-IgE therapy in patients with peanut allergy. N Engl J Med. 2003 Mar 13;348(11):986-93. doi: 10.1056/NEJMoa022613. Epub 2003 Mar 10.
PubMed 12637608Scadding GK, Brostoff J. Low dose sublingual therapy in patients with allergic rhinitis due to house dust mite. Clin Allergy. 1986 Sep;16(5):483-91. doi: 10.1111/j.1365-2222.1986.tb01983.x.
PubMed 3536171Tonnel AB, Scherpereel A, Douay B, Mellin B, Leprince D, Goldstein N, Delecluse P, Andre C. Allergic rhinitis due to house dust mites: evaluation of the efficacy of specific sublingual immunotherapy. Allergy. 2004 May;59(5):491-7. doi: 10.1111/j.1398-9995.2004.00456.x.
PubMed 15080829Canonica GW, Passalacqua G. Noninjection routes for immunotherapy. J Allergy Clin Immunol. 2003 Mar;111(3):437-48; quiz 449. doi: 10.1067/mai.2003.129.
PubMed 12642818Morris DL. Treatment of respiratory disease with ultra-small doses of antigens. Ann Allergy. 1970 Oct;28(10):494-500. No abstract available.
PubMed 5521180
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunotherapy for Peanut Allergy
- ClinicalTrials.gov ID
- NCT00429429
- Acronym / sponsor ID
- 1R21AT002557-02
- Conditions
- Allergy
- Keywords
- Peanut allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 31 Jan 2007 (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.
Currently, when a food allergy is diagnosed, the "standard of care" is strict avoidance of the allergic food and ready access to self-injectable epinephrine. Yet, accidental ingestions do occur. Unfortunately, for a ubiquitous food such as peanut, the possibility of an inadvertent ingestion is great. It is estimated that over 50% of individuals who are allergic to peanuts will have an accidental reaction to peanuts over a 2-year period. The purpose of this study is to determine if peanut sublingual immunotherapy (SLIT) reduces the number and/or symptoms of accidental peanut ingestion in peanut allergic subjects. We would anticipate that the subjects on the peanut SLIT protocol would experience few adverse effects with accidental peanut ingestion over the course of the two years of SLIT. The primary endpoint to evaluate the effectiveness of SLIT will be a negative DBPCFC to peanuts (8 grams) at the completion of the two years of the study.
Detailed description
Peanut allergy is one of the most serious of the immediate hypersensitivity reactions to foods in terms of persistence and severity of the reaction and appears to be a growing problem. Allergen-specific immunotherapy (IT) is currently being examined as a treatment option because of the persistence of this hypersensitivity reaction and the lack of effective treatment. An understanding of the molecular mechanisms of peanut-specific IT is vital to ensure the eventual, successful treatment of peanut-allergic patients.
The goal of this proposal is to develop peanut immunotherapy (IT) for patients with peanut allergic reactions. This innovative application is designed to utilize the extensive knowledge of the allergens involved in peanut hypersensitivity to devise an immunotherapeutic approach that would lower the risk of anaphylactic reactions and would down regulate peanut-specific T cells in peanut-allergic patients. Previous attempts to utilize peanut-specific immunotherapy have been unsuccessful primarily because of the severe side effects of therapy.
The specific aim of the study is to desensitize/tolerize peanut-allergic subjects with peanut allergen-specific, sublingual immunotherapy (SLIT) and begin to determine the molecular mechanism of the peanut-specific T-cell response during SLIT.
The hypothesis is that peanut SLIT will desensitize patients with peanut allergic reactions by the induction of peanut specific regulatory T cells resulting in immune modulation of the peanut allergic reaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peanut protein solution | Experimental | Procedure: Sublingual immunotherapySubjects receiving the peanut sublingual peanut protein drops. Sublingual Immunotherapy. |
Who may qualify
- Ages
- 6 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Subjects between 6 and 35 years of age
- Diagnosed with peanut allergy by positive prick skin test, CAP FEIA of 15 Ku/L or greater
- History of significant clinical symptoms within one hour after ingestion of peanuts
- Family's compliance with all study visits
Key exclusion criteria (4 listed)
- Subjects with medical history preventing a BDPCFC to peanut
- Subjects unable to cooperate with challenge procedure
- Subjects unable to be reached by telephone for follow-up
- Subjects with a history of severe anaphylaxis to peanut
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 |
|---|---|---|
| Sublingual immunotherapyAlso: Peanut protein solutionDrops of peanut protein placed and held under the tongue for a specific time before swallowed. | Procedure or surgery | Peanut protein solution |
Primary outcome
A negative double-blind placebo controlled food challenge at the completion the two years of the study.
Time frame: When IgE level drops to less than or equal to 2 ku/L
1 secondary outcome
A change in the cytokine level between the baseline and each selected time point during the two years of the study.
Time frame: Drop in cytokine level
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2016.
- Background: PubMed 11150011Bock SA, Munoz-Furlong A, Sampson HA. Fatalities due to anaphylactic reactions to foods. J Allergy Clin Immunol. 2001 Jan;107(1):191-3. doi: 10.1067/mai.2001.112031.
- Background: PubMed 10200001Sicherer SH, Munoz-Furlong A, Burks AW, Sampson HA. Prevalence of peanut and tree nut allergy in the US determined by a random digit dial telephone survey. J Allergy Clin Immunol. 1999 Apr;103(4):559-62. doi: 10.1016/s0091-6749(99)70224-1.
- Background: PubMed 14657884Sicherer SH, Munoz-Furlong A, Sampson HA. Prevalence of peanut and tree nut allergy in the United States determined by means of a random digit dial telephone survey: a 5-year follow-up study. J Allergy Clin Immunol. 2003 Dec;112(6):1203-7. doi: 10.1016/s0091-6749(03)02026-8.
- Background: PubMed 1500630Oppenheimer JJ, Nelson HS, Bock SA, Christensen F, Leung DY. Treatment of peanut allergy with rush immunotherapy. J Allergy Clin Immunol. 1992 Aug;90(2):256-62. doi: 10.1016/0091-6749(92)90080-l.
- Background: PubMed 12804442Wilson DR, Torres LI, Durham SR. Sublingual immunotherapy for allergic rhinitis. Cochrane Database Syst Rev. 2003;(2):CD002893. doi: 10.1002/14651858.CD002893.
- Background: PubMed 3722639Sloan AE, Powers ME. A perspective on popular perceptions of adverse reactions to foods. J Allergy Clin Immunol. 1986 Jul;78(1 Pt 2):127-33. doi: 10.1016/0091-6749(86)90002-3. No abstract available.
- Background: PubMed 8120272Jansen JJ, Kardinaal AF, Huijbers G, Vlieg-Boerstra BJ, Martens BP, Ockhuizen T. Prevalence of food allergy and intolerance in the adult Dutch population. J Allergy Clin Immunol. 1994 Feb;93(2):446-56. doi: 10.1016/0091-6749(94)90353-0.
- Background: PubMed 2600342Sampson HA. Food allergy. J Allergy Clin Immunol. 1989 Dec;84(6 Pt 2):1062-7. doi: 10.1016/0091-6749(89)90154-1. No abstract available.
- Background: PubMed 2213379Bock SA, Atkins FM. Patterns of food hypersensitivity during sixteen years of double-blind, placebo-controlled food challenges. J Pediatr. 1990 Oct;117(4):561-7. doi: 10.1016/s0022-3476(05)80689-4.
- Background: PubMed 2098016Valentine MD, Schuberth KC, Kagey-Sobotka A, Graft DF, Kwiterovich KA, Szklo M, Lichtenstein LM. The value of immunotherapy with venom in children with allergy to insect stings. N Engl J Med. 1990 Dec 6;323(23):1601-3. doi: 10.1056/NEJM199012063232305.
- Background: PubMed 12637608Leung DY, Sampson HA, Yunginger JW, Burks AW Jr, Schneider LC, Wortel CH, Davis FM, Hyun JD, Shanahan WR Jr; Avon Longitudinal Study of Parents and Children Study Team. Effect of anti-IgE therapy in patients with peanut allergy. N Engl J Med. 2003 Mar 13;348(11):986-93. doi: 10.1056/NEJMoa022613. Epub 2003 Mar 10.
- Background: PubMed 3536171Scadding GK, Brostoff J. Low dose sublingual therapy in patients with allergic rhinitis due to house dust mite. Clin Allergy. 1986 Sep;16(5):483-91. doi: 10.1111/j.1365-2222.1986.tb01983.x.
- Individual participant dataSharing planned: No
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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.
Wesley Burks, MD principal investigator
University of North Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sublingual immunotherapy in people with Allergy, run by University of North Carolina, Chapel Hill 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 20 Jun 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
A negative double-blind placebo controlled food challenge at the completion the two years of the study. (time frame: When IgE level drops to less than or equal to 2 ku/L). 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 NCT00429429, which also lists 23 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 20 Jun 2016.