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Peanut Allergy Vaccine Study in Healthy and Peanut-allergic Adults

Primary Purpose

Food Hypersensitivity, Hypersensitivity, Immediate Hypersensitivity

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
E. Coli-Encapsulated, Recombinant Modified Peanut Proteins Ara h 1, Ara h 2, and Ara h 3
Sponsored by
Allertein Therapeutics, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Food Hypersensitivity focused on measuring Food Allergy, Peanut Allergy

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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.

Sites / Locations

  • Johns Hopkins University
  • Mount Sinai Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

EMP-123

EMP-123 in Peanut Allergics

Arm Description

Participants who are not allergic to peanuts will receive four escalating doses of study product on a weekly basis

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

Outcomes

Primary Outcome Measures

Percentage of participants who successfully complete the dosage regimen with no more than mild symptoms related to EMP-123 dosing

Secondary Outcome Measures

Occurrence of adverse events
Rate of desensitization, as determined by peanut endpoint titration prick test in peanut allergic participants
Change in basophil activation
Decreased Type 2 helper T cell peanut-induced T-lymphocyte phenotype and increased T-lymphocyte regulatory phenotype
Increase in peanut-specific immunoglobulin (IgG4) and IgA
Decrease in peanut-specific IgE

Full Information

First Posted
February 24, 2009
Last Updated
May 23, 2013
Sponsor
Allertein Therapeutics, LLC
Collaborators
Consortium of Food Allergy Research
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1. Study Identification

Unique Protocol Identification Number
NCT00850668
Brief Title
Peanut Allergy Vaccine Study in Healthy and Peanut-allergic Adults
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allertein Therapeutics, LLC
Collaborators
Consortium of Food Allergy Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Hypersensitivity, Hypersensitivity, Immediate Hypersensitivity, Peanut Hypersensitivity
Keywords
Food Allergy, Peanut Allergy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EMP-123
Arm Type
Active Comparator
Arm Description
Participants who are not allergic to peanuts will receive four escalating doses of study product on a weekly basis
Arm Title
EMP-123 in Peanut Allergics
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
E. Coli-Encapsulated, Recombinant Modified Peanut Proteins Ara h 1, Ara h 2, and Ara h 3
Other Intervention Name(s)
EMP-123
Intervention Description
Up to 7 mL solution administered rectally
Primary Outcome Measure Information:
Title
Percentage of participants who successfully complete the dosage regimen with no more than mild symptoms related to EMP-123 dosing
Time Frame
Throughout study
Secondary Outcome Measure Information:
Title
Occurrence of adverse events
Time Frame
Throughout study
Title
Rate of desensitization, as determined by peanut endpoint titration prick test in peanut allergic participants
Time Frame
At pre- and post-treatment periods
Title
Change in basophil activation
Time Frame
Throughout study
Title
Decreased Type 2 helper T cell peanut-induced T-lymphocyte phenotype and increased T-lymphocyte regulatory phenotype
Time Frame
Throughout study
Title
Increase in peanut-specific immunoglobulin (IgG4) and IgA
Time Frame
Throughout study
Title
Decrease in peanut-specific IgE
Time Frame
Throughout study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert A. Wood, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Scott Sicherer, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19111571
Citation
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.
Results Reference
background
PubMed Identifier
17689596
Citation
Sicherer 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.
Results Reference
background

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Peanut Allergy Vaccine Study in Healthy and Peanut-allergic Adults

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