Immunotherapy for Peanut Allergy

NCT00429429 | Completed DMC

• 1 other identifier: 1R21AT002557-02
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Allergy

Keywords

Peanut allergy

Outcome Measures

Primary Outcomes (1)

• A negative double-blind placebo controlled food challenge at the completion the two years of the study.

  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.

  Drop in cytokine level

Study Arms (1)

Peanut protein solution

EXPERIMENTAL

Subjects receiving the peanut sublingual peanut protein drops. Sublingual Immunotherapy.

Procedure: Sublingual immunotherapy

Interventions

Sublingual immunotherapy PROCEDURE

Drops of peanut protein placed and held under the tongue for a specific time before swallowed.

Also known as: Peanut protein solution

Peanut protein solution

Eligibility Criteria

• Age: 6 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (23)

• 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.

  PMID: 11150011 BACKGROUND

• 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. doi: 10.1016/s0091-6749(99)70224-1.

  PMID: 10200001 BACKGROUND

• 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. doi: 10.1016/s0091-6749(03)02026-8.

  PMID: 14657884 BACKGROUND

• 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. doi: 10.1016/0091-6749(92)90080-l.

  PMID: 1500630 BACKGROUND

• Wilson DR, Torres LI, Durham SR. Sublingual immunotherapy for allergic rhinitis. Cochrane Database Syst Rev. 2003;(2):CD002893. doi: 10.1002/14651858.CD002893.

  PMID: 12804442 BACKGROUND

• Sloan 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.

  PMID: 3722639 BACKGROUND

• 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. doi: 10.1016/0091-6749(94)90353-0.

  PMID: 8120272 BACKGROUND

• Sampson 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.

  PMID: 2600342 BACKGROUND

• 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. doi: 10.1016/s0022-3476(05)80689-4.

  PMID: 2213379 BACKGROUND

• 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. doi: 10.1056/NEJM199012063232305.

  PMID: 2098016 BACKGROUND

• 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. doi: 10.1056/NEJMoa022613. Epub 2003 Mar 10.

  PMID: 12637608 BACKGROUND

• 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. doi: 10.1111/j.1365-2222.1986.tb01983.x.

  PMID: 3536171 BACKGROUND

• 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. doi: 10.1111/j.1398-9995.2004.00456.x.

  PMID: 15080829 BACKGROUND

• Canonica 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.

  PMID: 12642818 BACKGROUND

• Morris DL. Treatment of respiratory disease with ultra-small doses of antigens. Ann Allergy. 1970 Oct;28(10):494-500. No abstract available.

  PMID: 5521180 BACKGROUND

• Holt PG, Sly PD, Smith W. Sublingual immunotherapy for allergic respiratory disease. Lancet. 1998 Feb 28;351(9103):613-4. doi: 10.1016/S0140-6736(05)78425-7. No abstract available.

  PMID: 9500315 BACKGROUND

• 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. doi: 10.1159/000066779.

  PMID: 12444323 BACKGROUND

• Bousquet J, Michel FB. Specific immunotherapy in asthma. Allergy Proc. 1994 Nov-Dec;15(6):329-33. doi: 10.2500/108854194778816562.

  PMID: 7721083 BACKGROUND

• Morris DL, Kroker GF, Sabnis VK, Morris MS. Local immunotherapy in allergy. Chem Immunol Allergy. 2003;82:1-10. doi: 10.1159/000071537.

  PMID: 12947987 BACKGROUND

• 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. doi: 10.1002/1521-4141(200206)32:63.0.CO;2-Q.

  PMID: 12115645 BACKGROUND

• 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. doi: 10.1067/mai.2000.107395.

  PMID: 10887318 BACKGROUND

• 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. doi: 10.1006/clim.2001.5122.

  PMID: 11683581 BACKGROUND

• Cohen J. Statistical power analysis for the behavioral sciences. 2nd edition ed. Hillsdale, NJ: Erlbaum, 1988.

  BACKGROUND

MeSH Terms

Conditions

Hypersensitivity; Peanut Hypersensitivity

Interventions

Sublingual Immunotherapy

Condition Hierarchy (Ancestors)

Immune System Diseases; Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate

Intervention Hierarchy (Ancestors)

Desensitization, Immunologic; Immunosuppression Therapy; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• Wesley Burks, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Department of Pediatrics

Study Record Dates

• First Submitted: January 30, 2007
• First Posted: January 31, 2007
• Study Start: April 1, 2006
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: June 20, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)