Peanut AllergyPNOITNCT01324401
Oral Peanut Immunotherapy
A study testing Peanut flour OIT in people with Peanut Allergy, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Peanut allergy is one of the most serious food allergies because of its life long persistence, and the potential for severe allergic reactions. Effective oral immunotherapy would benefit patients by reducing the likelihood that they will have life-threatening accidental allergic reactions. Read more about this study
- Who is it for?
- Ages 7 to 21 years
- Conditions the study is for
- Peanut Allergy
- What is being tested?
- Peanut flour OIT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to May 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 7 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of peanut allergy by a positive prick skin test to peanut (> 8 mm reaction wheal) or CAP FEIA >10 and a history of objective clinical symptoms within one hour after ingestion of peanuts
- Ability to provide informed consent.
- Males and females of all ethnic/racial groups between 7 and 21 years who are otherwise healthy.
Who cannot join
- Clinical history of a severe anaphylactic reaction known or suspected to be caused by ingestion of peanut that required treatment with 2 or more administrations of epinephrine or hospitalization
- Moderate to Severe Asthma as defined using the Impairment or Risk Criteria of the current NHBLI Guidelines for the Diagnosis and Management of Asthma (http://www.nhlbi.nih.gov/guidelines/asthma/)
- Poorly controlled Asthma as defined using the Control Criteria of the current NHBLI Guidelines for the Diagnosis and Management of Asthma (http://www.nhlbi.nih.gov/guidelines/asthma/)
- Diagnosis of other severe or complicating medical problems
- Autoimmune or chronic immune or gastrointestinal inflammatory conditions, including Celiac Disease, Inflammatory Bowel Disease and Eosinophilic Gastrointestinal Disorders
- Primary Immune Deficiency
Show all 9Show fewer
- Use of beta blockers, angiotension converting enzyme inhibitors, or monoamine oxidase inhibitors
- Women of childbearing potential who are pregnant, planning to become pregnant, or breastfeeding
- Use within the past year of other systemic immunomodulatory treatment, including allergen immunotherapy, use of biologics with an immune target, including Xolair
Trial locations and contacts
1 site in 1 country.
United States1 site
Food Allergy Center; Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Peanut allergy is one of the most serious food allergies because of its life long persistence, and the potential for severe allergic reactions. Effective oral immunotherapy would benefit patients by reducing the likelihood that they will have life-threatening accidental allergic reactions. This research study is being done to develop an effective oral immunotherapy treatment for patients with peanut allergy.
Read the detailed description
Our hypothesis is that chronic antigen exposure during peanut oral immunotherapy (OIT) will induce beneficial changes in the specific immune response, including: 1) anergy of IgE effector immune cells (e.g., mast cells, basophils) resulting in clinical desensitization; 2) induction of de novo, long lived (memory) B cell responses that antagonize specific IgE and confer immune tolerance. The investigators will test this hypothesis in the following specific aims:
- Induce desensitization in peanut allergic subjects with peanut OIT and evaluate the safety of the peanut OIT desensitization protocol.
- Induce long-standing tolerance in peanut allergic subjects with maintenance peanut OIT and evaluate the efficacy of allergen-specific testing to predict tolerance.
- Longitudinally evaluate basophil and mast cell reactivity in subjects receiving peanut OIT and their relationship to the induction of desensitization.
- Longitudinally evaluate the allergen-specific B-cell repertoire in subjects receiving peanut OIT and its relationship to the induction of tolerance.
- Conditions
- Peanut Allergy
- Being tested
- Peanut flour OIT
- Keywords
- Peanut Allergy, Peanut Hypersensitivity
- Medical subject headings
- Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peanut flour OITDrug
Patients will receive daily escalating dosages (Peanut flour OIT) as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The subjects randomized to the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. These subjects are then offered to cross-over to active treatment. |
| Peanut OIT | Experimental | The subjects randomized to the active treatment group will receive defatted peanut flour per protocol. Receives: Drug: Peanut flour OIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance or Sustained Unresponsiveness
The consumption of 5 grams of peanut protein during a double-blind placebo controlled food challenge without objective symptoms after one month of post treatment avoidance
Measured: at least 36 months
Secondary outcomes (1)
Desensitization
The consumption of 5 grams of peanut protein during an open food challenge without objective symptoms immediately post treatment
Measured: at least 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionMay 2016
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peanut AllergyStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The observational control arm (parallel for the first year) was then offered to cross over to active treatment
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wayne G. Shreffler, MD, PhD, Massachusetts General Hospital
- Investigators
- Wayne G Shreffler, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01324401
- Sponsor's protocol ID
- 2010P000609
- Acronym
- PNOIT
- Status last verified
- Jul 2018
- First submitted
- 12 Aug 2010
- Last updated
- 8 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Peanut Immunotherapy
- ClinicalTrials.gov ID
- NCT01324401
- Acronym / sponsor ID
- PNOIT / 2010P000609
- Conditions
- Peanut Allergy
- Keywords
- Peanut Allergy, Peanut Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Mar 2011 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 29 Mar 2011 (estimated)
- Results
- Posted 20 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Peanut allergy is one of the most serious food allergies because of its life long persistence, and the potential for severe allergic reactions. Effective oral immunotherapy would benefit patients by reducing the likelihood that they will have life-threatening accidental allergic reactions. This research study is being done to develop an effective oral immunotherapy treatment for patients with peanut allergy.
Detailed description
Our hypothesis is that chronic antigen exposure during peanut oral immunotherapy (OIT) will induce beneficial changes in the specific immune response, including: 1) anergy of IgE effector immune cells (e.g., mast cells, basophils) resulting in clinical desensitization; 2) induction of de novo, long lived (memory) B cell responses that antagonize specific IgE and confer immune tolerance. The investigators will test this hypothesis in the following specific aims:
- Induce desensitization in peanut allergic subjects with peanut OIT and evaluate the safety of the peanut OIT desensitization protocol.
- Induce long-standing tolerance in peanut allergic subjects with maintenance peanut OIT and evaluate the efficacy of allergen-specific testing to predict tolerance.
- Longitudinally evaluate basophil and mast cell reactivity in subjects receiving peanut OIT and their relationship to the induction of desensitization.
- Longitudinally evaluate the allergen-specific B-cell repertoire in subjects receiving peanut OIT and its relationship to the induction of tolerance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The observational control arm (parallel for the first year) was then offered to cross over to active treatment
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The subjects randomized to the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. These subjects are then offered to cross-over to active treatment. |
| Peanut OIT | Experimental | Drug: Peanut flour OITThe subjects randomized to the active treatment group will receive defatted peanut flour per protocol. |
Who may qualify
- Ages
- 7 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Diagnosis of peanut allergy by a positive prick skin test to peanut (> 8 mm reaction wheal) or CAP FEIA >10 and a history of objective clinical symptoms within one hour after ingestion of peanuts
- Ability to provide informed consent.
- Males and females of all ethnic/racial groups between 7 and 21 years who are otherwise healthy.
Key exclusion criteria (9 listed)
- Clinical history of a severe anaphylactic reaction known or suspected to be caused by ingestion of peanut that required treatment with 2 or more administrations of epinephrine or hospitalization
- Moderate to Severe Asthma as defined using the Impairment or Risk Criteria of the current NHBLI Guidelines for the Diagnosis and Management of Asthma (http://www.nhlbi.nih.gov/guidelines/asthma/)
- Poorly controlled Asthma as defined using the Control Criteria of the current NHBLI Guidelines for the Diagnosis and Management of Asthma (http://www.nhlbi.nih.gov/guidelines/asthma/)
- Diagnosis of other severe or complicating medical problems
- Autoimmune or chronic immune or gastrointestinal inflammatory conditions, including Celiac Disease, Inflammatory Bowel Disease and Eosinophilic Gastrointestinal Disorders
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 |
|---|---|---|
| Peanut flour OITPatients will receive daily escalating dosages (Peanut flour OIT) as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly. | Drug | Peanut OIT |
Primary outcome
Tolerance or Sustained Unresponsiveness
Time frame: at least 36 months
The consumption of 5 grams of peanut protein during a double-blind placebo controlled food challenge without objective symptoms after one month of post treatment avoidance
1 secondary outcome
Desensitization
Time frame: at least 36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Wayne G Shreffler, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peanut flour OIT in people with Peanut Allergy, run by Massachusetts General Hospital 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 3 inclusion and 9 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 8 Aug 2018. 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?
Yes. Results are posted in the registry (first posted 20 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Tolerance or Sustained Unresponsiveness (time frame: at least 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Aug 2018; AzTrials last refreshed its copy on 28 Oct 2026.