Evaluation of Allergenicity of Hypoallergenic Peanut Product in Peanut Allergic Subjects

NCT01489514 | Completed

• 1 other identifier: IRB# 10-0851
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

This is a proof of concept study to determine the safety and allergenicity of hypoallergenic peanut product extract as compared to standard peanut extract in an adult population with known peanut allergy. This will be assessed by epicutaneous skin prick testing. The hypothesis is that subjects with previously diagnosed peanut allergy will have less epicutaneous reactions to the hypoallergenic peanut product extract.

Conditions

Peanut Allergy

Keywords

peanut allergy; hypoallergenic peanut extracts; epicutaneous skin prick testing

Outcome Measures

Primary Outcomes (1)

• Size of wheal with epicutaneous testing using non-hypoallergenic extracts.

  Size of wheal for hypoallergenic extracts will be measured.

  20 minutes

Study Arms (1)

Peanut allergic subjects

Other: Epicutaneous skin prick testing

Interventions

Epicutaneous skin prick testing OTHER

Epicutaneous skin prick testing will be performed utilizing the following extracts: 1. Histamine control purchased from Greer. 2. Saline control purchased from Greer. 3. Standard Peanut Extract purchased from Greer. 4. Sterile extract prepared from Trypsin and Chymotrypsin treated peanuts. This is prepared by North Carolina A \& T. 5. Sterile extract prepared from roasted \& blanched but untreated peanuts. This is prepared by North Carolina A \& T. 6. Sterile extract prepared from peanuts (no blanching, no enzyme). This is prepared by North Carolina A \& T. This is not classified as a drug and is 7. Sterile extract containing peanuts treated with 0.2% inactivated a-chymotrypsin and trypsin as an enzyme negative control. 8. Sterile extracts containing peanuts that have been treated with alcalase

Peanut allergic subjects

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Thirty (30) adult subjects with history of peanut allergy, with or without asthma will be recruited. All participants will be adults ages 18-65. There will no gender or ethnic restrictions.

You may qualify if:

• Specific allergy to peanut confirmed by positive immediate skin test response.
• Oxygen saturation of \> 94 % at baseline
• Blood pressure within the following parameters (Systolic between 140 - 90, Diastolic between 90-60 mm Hg)
• Must be willing and medically able to withhold antihistamine treatment (both H1 and H2) for 3 days prior to starting study medication, and for the duration of the treatment period. Any subject will be told to resume their antihistamine treatment if symptoms require resuming medication.

You may not qualify if:

• Asthmatic patients must be on a stable regimen of asthma therapy which has not changed in the past month prior to entrance into the study.
• Asthmatic or allergic non-asthmatic patients must not be on leukotriene receptor antagonists, as this may potentially interfere with epicutaneous skin testing and in vitro allergen-induced leukotriene production
• Pregnancy or nursing a baby. As this is a phase I study, the potential risk to a fetus cannot be justified.
• Children will not be included in this study as the potential risk to a growing child cannot be justified.
• Adults age 66 and older are excluded as the potential for concomitant illness in this population increases the risk for confounding the data.
• Known vagal response to venipuncture
• Hypertension, classified as a systolic blood pressure of equal to or greater than 140, and a diastolic blood pressure equal to or greater than 90.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• North Carolina Agriculture & Technical State University: collaborator

Study Sites (1)

Center for Environmental Medicine, Asthma and Lung Biology

Chapel Hill, North Carolina, 27516, United States

Location

Related Publications (1)

• Yu, J; Hernandez, M; Li, H; Goktepe, I; Robinette, C; Auerbach, A; Peden, D; Ahmedna, M. Allergenicity of roasted peanuts treated with a non-human digestive protease. Food Research International 2015 March; 69: 341-47. doi:10.1016/j.foodres.2015.01.007

  RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Venipuncture for 30mL of blood taken for measurement of peanut IgE.

MeSH Terms

Conditions

Peanut Hypersensitivity

Condition Hierarchy (Ancestors)

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

Study Officials

• Michelle Hernandez, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: December 7, 2011
• First Posted: December 9, 2011
• Study Start: December 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2015
• Last Updated: May 27, 2015

Record last verified: 2015-05

Locations

US (1)