Peanut AllergypeanutNCT01489514
Evaluation of Allergenicity of Hypoallergenic Peanut Product in Peanut Allergic Subjects
An observational study of Peanut Allergy, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Peanut Allergy
- What is being tested?
- Epicutaneous skin prick testing
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Any chronic medical condition including significant cardiovascular disease, diabetes requiring medication, chronic renal disease, chronic thyroid disease, kidney disease or coagulation defects. Asthma is not an exclusion criterion.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Environmental Medicine, Asthma and Lung Biology
Chapel Hill, North Carolina, 27516
About this study
Official title: Evaluation of Allergenicity of Hypoallergenic Peanut Product in Peanut Allergic Subjects.
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.
Read the detailed description
Peanut allergic volunteers will be identified by positive skin prick test to peanut (peanut extract obtained from Greer laboratories). The peanut extract to be used is FDA approved and is routinely used in confirming a diagnosis of peanut allergy. Serum Total IgE and peanut-specific IgE will be measured for assessment of atopy in general and confirmation of Peanut allergy respectively. Only patients with positive skin test to peanut will enrolled into the study.
Allergic volunteers will be asked to abstain from taking any antihistamines (H1 or H2) during the 3 days prior to the skin testing.
Testing day
- Obtain informed consent
- Obtain medical history, list of current medications
- Vital signs.
- Obtain urine pregnancy test if applicable
- Perform partial physical exam (PE) to include, ENT, Eyes, Neck, Respiratory, Cardiac and Skin with focus mainly on lungs to rule out bronchospasm/asthma exacerbation.
- Epicutaneous skin prick testing with histamine and saline control, standard peanut extract will be done on all subjects (Total skin prick=3). Those subjects who qualify for the study (test positive to standard peanut extract) will then undergo skin prick testing with standard histamine control, standard saline control, hypoallergenic (Trypsin+Chymotrypsin treated) extract, extract from blanched untreated (no enzyme) peanuts, non-blanched untreated extracts, and peanuts treated with 0.2% inactivated a-chymotrypsin and trypsin as an enzyme control. A second set of skin testing reagents may used these reagents have been treated with alcalase. Skin testing will be read at 15 minutes. A positive test is defined as ≥ 3mm wheal compared to saline control. DermaPIK device will be used for this skin prick testing.
- Obtain blood samples One time 20ml collection for determination of total IgE, peanut specific IgE in peanut allergic individuals only.
Physical Exams will be performed by a study physician. Procedures such as skin testing, vital signs, venipuncture, will be done by a study coordinator, qualified nurse or technical staff. Clinical labs (Serum IgE and Peanut-specific IgE) will be processed at Labcorp Inc in Burlington, NC.
Recording of Skin Test results: Skin test reactions will be traced onto clear cellophane tape from which measurements will be obtained. This tape will be affixed to a subject's visit record but not their personal medical record.
Excess samples remaining after completion of analyses for this study will be stored in the CEMALB Repository (IRB #05-2528) and all participants will be asked to sign the Repository consent form. Failure to consent to the repository will not result in exclusion from the main study.
- Conditions
- Peanut Allergy
- Being tested
- Epicutaneous skin prick testing
- Keywords
- peanut allergy, hypoallergenic peanut extracts, epicutaneous skin prick testing
- Medical subject headings
- Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epicutaneous skin prick testingOther
Epicutaneous skin prick testing will be performed utilizing the following extracts:
- Histamine control purchased from Greer.
- Saline control purchased from Greer.
- Standard Peanut Extract purchased from Greer.
- Sterile extract prepared from Trypsin and Chymotrypsin treated peanuts. This is prepared by North Carolina A \& T.
- Sterile extract prepared from roasted \& blanched but untreated peanuts. This is prepared by North Carolina A \& T.
- 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
- Sterile extract containing peanuts treated with 0.2% inactivated a-chymotrypsin and trypsin as an enzyme negative control.
- Sterile extracts containing peanuts that have been treated with alcalase
| Study group | Role | What they receive |
|---|---|---|
| Peanut allergic subjects | Not described Receives: Other: Epicutaneous skin prick testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Size of wheal with epicutaneous testing using non-hypoallergenic extracts.
Size of wheal for hypoallergenic extracts will be measured.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionJan 2013
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peanut AllergyStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- North Carolina Agriculture & Technical State University
- Responsible party
- Principal investigator, Michelle Hernandez, MD, University of North Carolina, Chapel Hill
- Investigators
- Michelle Hernandez, MD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01489514
- Sponsor's protocol ID
- IRB# 10-0851
- Acronym
- peanut
- Status last verified
- May 2015
- First submitted
- 7 Dec 2011
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Allergenicity of Hypoallergenic Peanut Product in Peanut Allergic Subjects.
- ClinicalTrials.gov ID
- NCT01489514
- Acronym / sponsor ID
- peanut / IRB# 10-0851
- Conditions
- Peanut Allergy
- Keywords
- peanut allergy, hypoallergenic peanut extracts, epicutaneous skin prick testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- North Carolina Agriculture & Technical State University
- Study start
- Dec 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 9 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Peanut allergic volunteers will be identified by positive skin prick test to peanut (peanut extract obtained from Greer laboratories). The peanut extract to be used is FDA approved and is routinely used in confirming a diagnosis of peanut allergy. Serum Total IgE and peanut-specific IgE will be measured for assessment of atopy in general and confirmation of Peanut allergy respectively. Only patients with positive skin test to peanut will enrolled into the study.
Allergic volunteers will be asked to abstain from taking any antihistamines (H1 or H2) during the 3 days prior to the skin testing.
Testing day
- Obtain informed consent
- Obtain medical history, list of current medications
- Vital signs.
- Obtain urine pregnancy test if applicable
- Perform partial physical exam (PE) to include, ENT, Eyes, Neck, Respiratory, Cardiac and Skin with focus mainly on lungs to rule out bronchospasm/asthma exacerbation.
- Epicutaneous skin prick testing with histamine and saline control, standard peanut extract will be done on all subjects (Total skin prick=3). Those subjects who qualify for the study (test positive to standard peanut extract) will then undergo skin prick testing with standard histamine control, standard saline control, hypoallergenic (Trypsin+Chymotrypsin treated) extract, extract from blanched untreated (no enzyme) peanuts, non-blanched untreated extracts, and peanuts treated with 0.2% inactivated a-chymotrypsin and trypsin as an enzyme control. A second set of skin testing reagents may used these reagents have been treated with alcalase. Skin testing will be read at 15 minutes. A positive test is defined as ≥ 3mm wheal compared to saline control. DermaPIK device will be used for this skin prick testing.
- Obtain blood samples One time 20ml collection for determination of total IgE, peanut specific IgE in peanut allergic individuals only.
Physical Exams will be performed by a study physician. Procedures such as skin testing, vital signs, venipuncture, will be done by a study coordinator, qualified nurse or technical staff. Clinical labs (Serum IgE and Peanut-specific IgE) will be processed at Labcorp Inc in Burlington, NC.
Recording of Skin Test results: Skin test reactions will be traced onto clear cellophane tape from which measurements will be obtained. This tape will be affixed to a subject's visit record but not their personal medical record.
Excess samples remaining after completion of analyses for this study will be stored in the CEMALB Repository (IRB #05-2528) and all participants will be asked to sign the Repository consent form. Failure to consent to the repository will not result in exclusion from the main study.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peanut allergic subjects | – | Other: Epicutaneous skin prick testing |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- Any chronic medical condition including significant cardiovascular disease, diabetes requiring medication, chronic renal disease, chronic thyroid disease, kidney disease or coagulation defects. Asthma is not an exclusion criterion.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epicutaneous skin prick testingEpicutaneous 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 | Other | Peanut allergic subjects |
Primary outcome
Size of wheal with epicutaneous testing using non-hypoallergenic extracts.
Time frame: 20 minutes
Size of wheal for hypoallergenic extracts will be measured.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
- Results publicationYu, 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Hernandez, MD principal investigator
University of North Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peanut Allergy, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Size of wheal with epicutaneous testing using non-hypoallergenic extracts. (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01489514, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2015.