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Immunotherapy for Peanut Allergy
This study is ongoing, but not recruiting participants.
Sponsored by: Duke University
Information provided by: Duke University
ClinicalTrials.gov Identifier: NCT00429429
  Purpose

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.


Condition Intervention
Allergy
Procedure: Sublingual immunotherapy

MedlinePlus related topics: Allergy
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title: Immunotherapy for Peanut Allergy

Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: April 2006
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Drops of peanut protein: Experimental
Subjects receiving the peanut sublingual peanut protein drops.
Procedure: Sublingual immunotherapy
Drops of peanut protein placed and held under the tongue for a specific time before swallowed.

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.

  Eligibility

Ages Eligible for Study:   6 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00429429

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Wesley Burks, MD Duke University
  More Information

Publications:
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Sicherer 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.
Sicherer 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.
Oppenheimer 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.
Wilson DR, Torres LI, Durham SR. Sublingual immunotherapy for allergic rhinitis. Cochrane Database Syst Rev. 2003;(2):CD002893. Review.
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Jansen 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.
Sampson HA. Food allergy. J Allergy Clin Immunol 1989; 84(6 Pt 2):1062-7.
Bock 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.
Valentine 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.
Leung 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. Epub 2003 Mar 10.
Scadding 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.
Tonnel 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.
Canonica GW, Passalacqua G. Noninjection routes for immunotherapy. J Allergy Clin Immunol. 2003 Mar;111(3):437-48; quiz 449. Review.
Morris DL. Treatment of respiratory disease with ultra-small doses of antigens. Ann Allergy. 1970 Oct;28(10):494-500. No abstract available.
Holt PG, Sly PD, Smith W. Sublingual immunotherapy for allergic respiratory disease. Lancet. 1998 Feb 28;351(9103):613-4. No abstract available.
Grosclaude M, Bouillot P, Alt R, Leynadier F, Scheinmann P, Rufin P, Basset D, Fadel R, Andre C. Safety of various dosage regimens during induction of sublingual immunotherapy. A preliminary study. Int Arch Allergy Immunol. 2002 Nov;129(3):248-53.
Bousquet J, Michel FB. Specific immunotherapy in asthma. Allergy Proc. 1994 Nov-Dec;15(6):329-33. Review.
Morris DL, Kroker GF, Sabnis VK, Morris MS. Local immunotherapy in allergy. Chem Immunol Allergy. 2003;82:1-10. Review.
Taams LS, Vukmanovic-Stejic M, Smith J, Dunne PJ, Fletcher JM, Plunkett FJ, Ebeling SB, Lombardi G, Rustin MH, Bijlsma JW, Lafeber FP, Salmon M, Akbar AN. Antigen-specific T cell suppression by human CD4+CD25+ regulatory T cells. Eur J Immunol. 2002 Jun;32(6):1621-30.
Li XM, Serebrisky D, Lee SY, Huang CK, Bardina L, Schofield BH, Stanley JS, Burks AW, Bannon GA, Sampson HA. A murine model of peanut anaphylaxis: T- and B-cell responses to a major peanut allergen mimic human responses. J Allergy Clin Immunol. 2000 Jul;106(1 Pt 1):150-8.
Lee SY, Huang CK, Zhang TF, Schofield BH, Burks AW, Bannon GA, Sampson HA, Li XM. Oral administration of IL-12 suppresses anaphylactic reactions in a murine model of peanut hypersensitivity. Clin Immunol. 2001 Nov;101(2):220-8.
Cohen J. Statistical power analysis for the behavioral sciences. 2nd edition ed. Hillsdale, NJ: Erlbaum, 1988.

Responsible Party: Duke University Medical Center ( Wesley Burks, MD )
Study ID Numbers: 1 R21-AT-002557-02
Study First Received: January 30, 2007
Last Updated: December 26, 2008
ClinicalTrials.gov Identifier: NCT00429429  
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Peanut allergy

Study placed in the following topic categories:
Food Hypersensitivity
Hypersensitivity
Peanut Hypersensitivity
Hypersensitivity, Immediate

Additional relevant MeSH terms:
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009