Peanut Oral Immunotherapy (OIT) - Initial Pilot Study in Adults

This study is currently recruiting participants.

Verified May 2013 by University of North Carolina, Chapel Hill

Sponsor:

Information provided by (Responsible Party):

Wesley Burks, MD, University of North Carolina, Chapel Hill

ClinicalTrials.gov Identifier:

NCT01274429

First received: January 9, 2011

Last updated: May 3, 2013

Last verified: May 2013

History of Changes

Purpose

The goal of this proposal is to produce a new treatment that would benefit subjects who have peanut allergy by lowering the risk of anaphylactic reactions (desensitization), and changing the peanut-specific immune response in subjects who have peanut allergy (tolerance). This is a research study to test stimulation of the immune system to improve peanut allergy. The approach the investigators will use for peanut allergy is called desensitization. A person becomes desensitized to a food by taking small, increasing amounts of the food to help the body become used to the food so that it no longer causes a severe allergic reaction.

The study also looks at the safety and immune system effects of the investigational study product, peanut protein. The word "investigational" means the study product is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA).

This project is designed to study if peanut oral immunotherapy (POIT) will desensitize subjects with peanut hypersensitivity by regulating their oral and systemic immune reactivity and cause long-term tolerance.

Condition	Intervention	Phase
Peanut Allergy	Drug: powdered peanut protein	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Peanut Oral Immunotherapy (OIT) - Initial Pilot Study in Adults

Resource links provided by NLM:

MedlinePlus related topics: Allergy

U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:

To treat peanut-allergic subjects with POIT and to determine whether this protocol lowers their risk of anaphylactic reactions and causes long-term tolerance. [ Time Frame: 4.5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To determine the effect that POIT has on the peanut-specific cellular and humoral response in peanut-allergic subjects. [ Time Frame: 4.5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	December 2010
Estimated Study Completion Date:	September 2015
Estimated Primary Completion Date:	September 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Peanut protein	Drug: powdered peanut protein Active peanut allergy will be confirmed in all subjects with Double Blind Placebo Controlled Food Challenge 2 gm peanut protein oral food challenge prior to entry into the study. Oral desensitization begins with the modified rush. The first dose is 0.1 mg of peanut protein, the dose is doubled every 30 minutes until a maximum of 6 mg of peanut protein. The daily dose will be given at home until the scheduled escalation visit. Subjects return for escalation visits in the Food Allergy Study Center (FACS) every two weeks. The maintenance phase begins once the subject reaches 2300mg. This dose is taken daily. The maintenance phase begins once the subject reaches 2300mg which they take daily at home. All subjects will have a Double-Blind Placebo-Controlled Food Challenge at the end of 18 months of OIT to assess for desensitization.

Arms

Assigned Interventions

Experimental: Peanut protein

Drug: powdered peanut protein

Active peanut allergy will be confirmed in all subjects with Double Blind Placebo Controlled Food Challenge 2 gm peanut protein oral food challenge prior to entry into the study. Oral desensitization begins with the modified rush. The first dose is 0.1 mg of peanut protein, the dose is doubled every 30 minutes until a maximum of 6 mg of peanut protein. The daily dose will be given at home until the scheduled escalation visit. Subjects return for escalation visits in the Food Allergy Study Center (FACS) every two weeks. The maintenance phase begins once the subject reaches 2300mg. This dose is taken daily. The maintenance phase begins once the subject reaches 2300mg which they take daily at home. All subjects will have a Double-Blind Placebo-Controlled Food Challenge at the end of 18 months of OIT to assess for desensitization.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Age 18 to 50 years of age of any gender, race, or ethnicity.
Diagnosis of peanut allergy OR convincing clinical history of peanut allergy.
Detectable serum peanut -specific Immune globin E(IgE) level (CAP-FEIA ≥ 0.35 kU/L) and a positive SPT.
Participant willing to use effective method of contraception if female for the duration of the study, not pregnant or lactating, and not planning to become pregnant.
Positive reaction to ≤ 2 gm peanut protein on entry challenge.

Exclusion Criteria:

History of severe anaphylaxis to peanut per current NCI-CTCAE allergic reaction toxicity grading (see appendix .
Known sensitivity or intolerance to Oats.
FEV1 value <80% predicted or any clinical features of moderate or persistent asthma per 2007 NHLBI guidelines (see appendix #).
Exacerbation of asthma in the past year requiring hospitalization or greater than 1 ED visit for asthma in the past 6 months.
Use B-blockers, ACE inhibitors, ARB, or calcium channel blockers, xolair, or immunological treatments.
Uncontrolled hypertension per JNC 7 Guidelines (BP > 145/95 seated readings on each of two or more office visits).
Active eosinophilic gastrointestinal disease which could be exacerbated by peanut oral immunotherapy.
Chronic diseases such as diabetes, liver, gastrointestinal, kidney, cardiovascular, pulmonary disease, blood disorders, or history of ischemic cardiovascular disease, or other conditions that in the opinion of the Investigator make the subject unsuitable for induction of food allergy reactions.
Unable to speak English.
Inability to discontinue antihistamines prior to food challenges and skin prick tests.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01274429

Contacts

Contact: Janet S Kamilaris, RN	(919)962-4413	janet.kamilaris@unc.edu
Contact: Pamela H Steele, CPNP	(919)962-4416	pamela.steele@unc.edu

Locations

United States, North Carolina
University of North Carolina	Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Pamela H Steele, CPNP pamela.steele@unc.edu
Contact: Janet S Kamilaris, RN janet.kamilaris@unc.edu
Principal Investigator: A. Wesley Burks, MD

Sponsors and Collaborators

University of North Carolina, Chapel Hill

Investigators

Principal Investigator:

Wesley Burks, MD

Duke University

More Information

No publications provided

Responsible Party:	Wesley Burks, MD, Chairman, Department of Pediatrics, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT01274429 History of Changes
Other Study ID Numbers:	Pro00023033
Study First Received:	January 9, 2011
Last Updated:	May 3, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013

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