Food HypersensitivityPhase 1NCT00850668
Peanut Allergy Vaccine Study in Healthy and Peanut-allergic Adults
A Phase 1 study testing E. Coli-Encapsulated, Recombinant Modified Peanut Proteins Ara h 1, Ara h 2, and Ara h 3 in people with Food Hypersensitivity and Hypersensitivity, run by Allertein Therapeutics, LLC at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and side effects of a study product that contains recombinant modified peanut proteins (EMP-123) in healthy and peanut-allergic participants. This is a first in human study. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Hypersensitivity, Hypersensitivity, Immediate Hypersensitivity
- What is being tested?
- E. Coli-Encapsulated, Recombinant Modified Peanut Proteins Ara h 1, Ara h 2, and Ara h 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2009to Oct 2010
- Phase
- Phase 1
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Available for the duration of the trial
- Ability to perform spirometry maneuvers
- Agree to use effective methods of contraception for the duration of the study
- For Step 1 participants, regular consumption of at least 5 grams of peanut at least twice per month during the last 6 months prior to study entry
- For Step 2 participants, a convincing clinical history of peanut allergy and prick skin test positive to peanut. More information on these criteria can be found in the protocol.
Who cannot join
- History of any severe anaphylaxis
- Known allergy to hydroxypropyl methylcellulose, glycerol, or phenol
- Evidence of clinically significant immunosuppressive neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease
- Laboratory evidence of liver or hematologic disease. Pre-existing history of autoimmune or antibody mediated diseases. More information on this criterion can be found in the protocol.
- Pre-existing history of autoimmune or antibody mediated diseases. More information on this criterion can be found in the protocol.
- Any previous intubation due to allergies or asthma
Show all 41Show fewer
- History of ischemic cardiovascular disease
- Uncontrolled hypertension
- Significant medical condition that, in the opinion of the investigator, would interfere with the study
- Chronic diarrhea
- Inability to refrain from anal intercourse for the duration of the trial
- Use of rectal medications during the study
- Planned rectal procedures for the duration of the study
- History of rectal surgery or bleeding in the last 6 months prior to study entry
- History of proctitis in the last 6 months prior to study entry
- History of inflammatory bowel disease, celiac disease, or eosinophilic esophagitis/gastroenteritis
- Participation in another investigational vaccine or drug trial within 30 days prior to study or while the study is ongoing
- Medical, occupational, or family problems as a result of alcohol or illicit drug use during the last 12 months prior to study entry
- FEV1 value less than 80% predicted
- Inability to discontinue antihistamines for skin testing
- Currently on any allergy immunotherapy
- Participation in any interventional study for the treatment of food allergy in the past 12 months prior to study entry
- Poor control of persistent activation of atopic dermatitis
- Use of omalizumab or other non-traditional forms of allergen immunotherapy or immunomodulatory therapy or biologic therapy within the past 12 months prior to study entry
- Use of oral B-blockers, angiotensin-receptor blockers, or calcium channel blockers
- Use of immunosuppressive drugs within 30 days prior to study entry or while study is ongoing
- Use of corticosteroids within 30 days prior to study entry
- Use of steroid medications. More information on this criterion can be found in the protocol.
- History of serologic evidence of infection with HIV-1, HBV, or HCV
- Receipt of blood products within the past 6 months prior to study entry
- Inability to refrain from anal intercourse for the duration of the study
- Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, would interfere with the study
- Pregnant or breastfeeding
- Step 1 participants:
- History of any allergy to food, including peanut
- Serum peanut-specific IgE greater than .35 kUa/L at screening
- Prick skin test (PST) to peanut more than 3mm in diameter at screening
- History of asthma
- Step 2 participants:
- More than mild persistent asthma as defined in the protocol.
- Treatment for asthma, including: any hospitalization in the past year for asthma or any emergency room visit in the past 6 months for asthma.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins University
Baltimore, Maryland, 21205
Mount Sinai Medical Center
New York, New York, 10029
About this study
Official title: A Phase 1 Study of Heat/Phenol-Killed, E. Coli-Encapsulated, Recombinant Modified Peanut Proteins Ara h 1, Ara h 2, and Ara h 3 (EMP 123) in Healthy Volunteers Followed by Subjects Allergic to Peanuts (CoFAR 1)
The purpose of this study is to evaluate the safety and side effects of a study product that contains recombinant modified peanut proteins (EMP-123) in healthy and peanut-allergic participants. This is a first in human study.
As of November 2009, this study is no longer recruiting healthy volunteers and will only be recruiting individuals with peanut allergies.
Read the detailed description
Peanut allergy is a common ailment in the United States. Research suggests that the prevalence of peanut allergy in the United States has doubled over the last 5 years. Currently, the only effective treatment for peanut allergy is a peanut-free diet and quick access to self-injectable epinephrine. This study will evaluate the safety of a rectally administered product, EMP-123, consisting of three recombinant modified peanut protein antigens encapsulated within dead E. coli. E. coli is a common bacterium found in everyone's colon. E. coli acts like a package to hold the modified peanut proteins. EMP-123 is designed to act as an allergy vaccine with an eventual goal to induce tolerance to the major peanut proteins responsible for peanut allergy.
This study will involve weekly dosing and for females, a pregnancy test will occur at 48 hours before the start of product administration and later during the study. The study will involve two steps. Step 1 will enroll 5 healthy participants who will receive four escalating doses of study product on a weekly basis. Participants will be monitored at the clinic for 2 hours after receiving each dose of study product. Each dosing visit will be followed with a phone interview to assess any adverse effects or symptoms. Participants in Step 1 will maintain a home diary and record any symptoms that occur between visits. After screening, Step 1 will consist of five study visits on Weeks 1, 2, 3, 4, and 8. Vital signs, adverse event monitoring, and review of the home diary will occur at all visits. Breathing tests will occur at most visits. Stool and urine collection will occur at Weeks 4 and 8. The expected duration of Step 1 is 8 weeks.
If no safety concerns are identified at the conclusion of Step 1, 10 peanut-allergic participants will be enrolled into the second phase of the study, Step 2.
Step 2 is expected to last 20 weeks. Participants in Step 2 will receive weekly dose escalation of the study product for 10 weeks followed by administration every 2 weeks for 6 weeks. Participants will remain in the clinic for 2 hours after every dose is received. Follow-up will then continue for 4 weeks after the conclusion of treatment. Each dosing visit will be followed with a phone interview to assess any adverse effects or symptoms. After screening, Step 2 will consist of 14 study visits. Vital signs, adverse event monitoring, and a review of the home diary will occur at all visits. Breathing tests will occur at most visits. A skin prick test and stool, blood, and urine collection will occur at select visits.
As of November 2009, this study is no longer recruiting healthy volunteers and will only be recruiting individuals with peanut allergies.
- Conditions
- Food Hypersensitivity, Hypersensitivity, Immediate Hypersensitivity, Peanut Hypersensitivity
- Being tested
- E. Coli-Encapsulated, Recombinant Modified Peanut Proteins Ara h 1, Ara h 2, and Ara h 3
- Keywords
- Food Allergy, Peanut Allergy
- Medical subject headings
- Food Hypersensitivity, Hypersensitivity, Hypersensitivity, Immediate, Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E. Coli-Encapsulated, Recombinant Modified Peanut Proteins Ara h 1, Ara h 2, and Ara h 3Biological
Also called EMP-123
Up to 7 mL solution administered rectally
| Study group | Role | What they receive |
|---|---|---|
| EMP-123 | Active comparator | Participants who are not allergic to peanuts will receive four escalating doses of study product on a weekly basis Receives: Biological: E. Coli-Encapsulated, Recombinant Modified Peanut Proteins Ara h 1, Ara h 2, and Ara h 3 |
| EMP-123 in Peanut Allergics | Experimental | Participants who are allergic to peanuts will receive weekly dose escalation of the study product for 10 weeks followed by administration every 2 weeks for 6 weeks Receives: Biological: E. Coli-Encapsulated, Recombinant Modified Peanut Proteins Ara h 1, Ara h 2, and Ara h 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who successfully complete the dosage regimen with no more than mild symptoms related to EMP-123 dosing
Measured: Throughout study
Secondary outcomes (6)
Occurrence of adverse events
Measured: Throughout study
Rate of desensitization, as determined by peanut endpoint titration prick test in peanut allergic participants
Measured: At pre- and post-treatment periods
Change in basophil activation
Measured: Throughout study
Decreased Type 2 helper T cell peanut-induced T-lymphocyte phenotype and increased T-lymphocyte regulatory phenotype
Measured: Throughout study
Increase in peanut-specific immunoglobulin (IgG4) and IgA
Measured: Throughout study
Decrease in peanut-specific IgE
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Food HypersensitivityStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allertein Therapeutics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Consortium of Food Allergy Research
- Responsible party
- Sponsor
- Investigators
- Robert A. Wood, MD, Study chair, Johns Hopkins UniversityScott Sicherer, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00850668
- Sponsor's protocol ID
- DAIT CoFAR1
- Other IDs
- COFAR, APA-001
- Status last verified
- May 2013
- First submitted
- 24 Feb 2009
- Last updated
- 27 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rolland JM, Gardner LM, O'Hehir RE. Allergen-related approaches to immunotherapy. Pharmacol Ther. 2009 Mar;121(3):273-84. doi: 10.1016/j.pharmthera.2008.11.007. Epub 2008 Dec 7.
PubMed 19111571Sicherer SH, Sampson HA. Peanut allergy: emerging concepts and approaches for an apparent epidemic. J Allergy Clin Immunol. 2007 Sep;120(3):491-503; quiz 504-5. doi: 10.1016/j.jaci.2007.07.015. Epub 2007 Aug 8.
PubMed 17689596
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Heat/Phenol-Killed, E. Coli-Encapsulated, Recombinant Modified Peanut Proteins Ara h 1, Ara h 2, and Ara h 3 (EMP 123) in Healthy Volunteers Followed by Subjects Allergic to Peanuts (CoFAR 1)
- ClinicalTrials.gov ID
- NCT00850668
- Acronym / sponsor ID
- DAIT CoFAR1
- Conditions
- Food Hypersensitivity, Hypersensitivity, Immediate Hypersensitivity, Peanut Hypersensitivity
- Keywords
- Food Allergy, Peanut Allergy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Allertein Therapeutics, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Consortium of Food Allergy Research
- Study start
- Oct 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 25 Feb 2009 (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.
The purpose of this study is to evaluate the safety and side effects of a study product that contains recombinant modified peanut proteins (EMP-123) in healthy and peanut-allergic participants. This is a first in human study.
As of November 2009, this study is no longer recruiting healthy volunteers and will only be recruiting individuals with peanut allergies.
Detailed description
Peanut allergy is a common ailment in the United States. Research suggests that the prevalence of peanut allergy in the United States has doubled over the last 5 years. Currently, the only effective treatment for peanut allergy is a peanut-free diet and quick access to self-injectable epinephrine. This study will evaluate the safety of a rectally administered product, EMP-123, consisting of three recombinant modified peanut protein antigens encapsulated within dead E. coli. E. coli is a common bacterium found in everyone's colon. E. coli acts like a package to hold the modified peanut proteins. EMP-123 is designed to act as an allergy vaccine with an eventual goal to induce tolerance to the major peanut proteins responsible for peanut allergy.
This study will involve weekly dosing and for females, a pregnancy test will occur at 48 hours before the start of product administration and later during the study. The study will involve two steps. Step 1 will enroll 5 healthy participants who will receive four escalating doses of study product on a weekly basis. Participants will be monitored at the clinic for 2 hours after receiving each dose of study product. Each dosing visit will be followed with a phone interview to assess any adverse effects or symptoms. Participants in Step 1 will maintain a home diary and record any symptoms that occur between visits. After screening, Step 1 will consist of five study visits on Weeks 1, 2, 3, 4, and 8. Vital signs, adverse event monitoring, and review of the home diary will occur at all visits. Breathing tests will occur at most visits. Stool and urine collection will occur at Weeks 4 and 8. The expected duration of Step 1 is 8 weeks.
If no safety concerns are identified at the conclusion of Step 1, 10 peanut-allergic participants will be enrolled into the second phase of the study, Step 2.
Step 2 is expected to last 20 weeks. Participants in Step 2 will receive weekly dose escalation of the study product for 10 weeks followed by administration every 2 weeks for 6 weeks. Participants will remain in the clinic for 2 hours after every dose is received. Follow-up will then continue for 4 weeks after the conclusion of treatment. Each dosing visit will be followed with a phone interview to assess any adverse effects or symptoms. After screening, Step 2 will consist of 14 study visits. Vital signs, adverse event monitoring, and a review of the home diary will occur at all visits. Breathing tests will occur at most visits. A skin prick test and stool, blood, and urine collection will occur at select visits.
As of November 2009, this study is no longer recruiting healthy volunteers and will only be recruiting individuals with peanut allergies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMP-123 | Active comparator | Biological: E. Coli-Encapsulated, Recombinant Modified Peanut Proteins Ara h 1, Ara h 2, and Ara h 3Participants who are not allergic to peanuts will receive four escalating doses of study product on a weekly basis |
| EMP-123 in Peanut Allergics | Experimental | Biological: E. Coli-Encapsulated, Recombinant Modified Peanut Proteins Ara h 1, Ara h 2, and Ara h 3Participants who are allergic to peanuts will receive weekly dose escalation of the study product for 10 weeks followed by administration every 2 weeks for 6 weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Available for the duration of the trial
- Ability to perform spirometry maneuvers
- Agree to use effective methods of contraception for the duration of the study
- For Step 1 participants, regular consumption of at least 5 grams of peanut at least twice per month during the last 6 months prior to study entry
- For Step 2 participants, a convincing clinical history of peanut allergy and prick skin test positive to peanut. More information on these criteria can be found in the protocol.
Key exclusion criteria (41 listed)
- History of any severe anaphylaxis
- Known allergy to hydroxypropyl methylcellulose, glycerol, or phenol
- Evidence of clinically significant immunosuppressive neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease
- Laboratory evidence of liver or hematologic disease. Pre-existing history of autoimmune or antibody mediated diseases. More information on this criterion can be found in the protocol.
- Pre-existing history of autoimmune or antibody mediated diseases. More information on this criterion can be found in the protocol.
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 |
|---|---|---|
| E. Coli-Encapsulated, Recombinant Modified Peanut Proteins Ara h 1, Ara h 2, and Ara h 3Also: EMP-123Up to 7 mL solution administered rectally | Biological | EMP-123, EMP-123 in Peanut Allergics |
Primary outcome
Percentage of participants who successfully complete the dosage regimen with no more than mild symptoms related to EMP-123 dosing
Time frame: Throughout study
6 secondary outcomes
Occurrence of adverse events
Time frame: Throughout study
Rate of desensitization, as determined by peanut endpoint titration prick test in peanut allergic participants
Time frame: At pre- and post-treatment periods
Change in basophil activation
Time frame: Throughout study
Decreased Type 2 helper T cell peanut-induced T-lymphocyte phenotype and increased T-lymphocyte regulatory phenotype
Time frame: Throughout study
Increase in peanut-specific immunoglobulin (IgG4) and IgA
Time frame: Throughout study
Decrease in peanut-specific IgE
Time frame: Throughout study
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 2013.
- Background: PubMed 19111571Rolland JM, Gardner LM, O'Hehir RE. Allergen-related approaches to immunotherapy. Pharmacol Ther. 2009 Mar;121(3):273-84. doi: 10.1016/j.pharmthera.2008.11.007. Epub 2008 Dec 7.
- Background: PubMed 17689596Sicherer SH, Sampson HA. Peanut allergy: emerging concepts and approaches for an apparent epidemic. J Allergy Clin Immunol. 2007 Sep;120(3):491-503; quiz 504-5. doi: 10.1016/j.jaci.2007.07.015. Epub 2007 Aug 8.
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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.
Robert A. Wood, MD study chair
Johns Hopkins University
Scott Sicherer, MD principal investigator
Icahn School of Medicine at Mount Sinai
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing E. Coli-Encapsulated, Recombinant Modified Peanut Proteins Ara h 1, Ara h 2, and Ara h 3 in people with Food Hypersensitivity and Hypersensitivity, run by Allertein Therapeutics, LLC at 2 sites 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 5 inclusion and 41 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 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Percentage of participants who successfully complete the dosage regimen with no more than mild symptoms related to EMP-123 dosing (time frame: Throughout study). 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 NCT00850668, which also lists 2 linked publications.
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 2013.