Immunotherapy for Peanut Allergy

Allergy Clinical Trial

Official title:

Immunotherapy for Peanut Allergy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00429429
• Other study ID #: 1 R21-AT-002557-02
• Status: Completed
• Phase: N/A
• First received: January 30, 2007
• Last updated: June 16, 2016
• Start date: April 2006
• Est. completion date: May 2011

Study information

• Verified date: June 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 35 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergy
• Hypersensitivity
• Peanut Hypersensitivity

Intervention

Procedure:
• Sublingual immunotherapy
Drops of peanut protein placed and held under the tongue for a specific time before swallowed.

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

References & Publications (23)

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. — View Citation

Bock SA, Muñoz-Furlong A, Sampson HA. Fatalities due to anaphylactic reactions to foods. J Allergy Clin Immunol. 2001 Jan;107(1):191-3. — View Citation

Bousquet J, Michel FB. Specific immunotherapy in asthma. Allergy Proc. 1994 Nov-Dec;15(6):329-33. Review. — View Citation

Canonica GW, Passalacqua G. Noninjection routes for immunotherapy. J Allergy Clin Immunol. 2003 Mar;111(3):437-48; quiz 449. Review. — View Citation

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

Grosclaude M, Bouillot P, Alt R, Leynadier F, Scheinmann P, Rufin P, Basset D, Fadel R, André C. Safety of various dosage regimens during induction of sublingual immunotherapy. A preliminary study. Int Arch Allergy Immunol. 2002 Nov;129(3):248-53. — View Citation

Holt PG, Sly PD, Smith W. Sublingual immunotherapy for allergic respiratory disease. Lancet. 1998 Feb 28;351(9103):613-4. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Morris DL, Kroker GF, Sabnis VK, Morris MS. Local immunotherapy in allergy. Chem Immunol Allergy. 2003;82:1-10. Review. — View Citation

Morris DL. Treatment of respiratory disease with ultra-small doses of antigens. Ann Allergy. 1970 Oct;28(10):494-500. — View Citation

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. — View Citation

Sampson HA. Food allergy. J Allergy Clin Immunol. 1989 Dec;84(6 Pt 2):1062-7. — View Citation

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. — View Citation

Sicherer SH, Muñoz-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. — View Citation

Sicherer SH, Muñoz-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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Wilson DR, Torres LI, Durham SR. Sublingual immunotherapy for allergic rhinitis. Cochrane Database Syst Rev. 2003;(2):CD002893. Review. Update in: Cochrane Database Syst Rev. 2010;(12):CD002893. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No