Peanut Allergy Vaccine Study in Healthy and Peanut-allergic Adults

NCT00850668 | Completed Phase 1 DMC

• 3 other identifiers: DAIT CoFAR1COFARAPA-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

Food Hypersensitivity; Hypersensitivity; Immediate Hypersensitivity; Peanut Hypersensitivity

Keywords

Food Allergy; Peanut Allergy

Outcome Measures

Primary Outcomes (1)

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

  Throughout study

Secondary Outcomes (6)

• Occurrence of adverse events

  Throughout study

• Rate of desensitization, as determined by peanut endpoint titration prick test in peanut allergic participants

  At pre- and post-treatment periods

• Change in basophil activation

  Throughout study

• Decreased Type 2 helper T cell peanut-induced T-lymphocyte phenotype and increased T-lymphocyte regulatory phenotype

  Throughout study

• Increase in peanut-specific immunoglobulin (IgG4) and IgA

  Throughout study

Study Arms (2)

EMP-123

ACTIVE COMPARATOR

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

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

Biological: E. Coli-Encapsulated, Recombinant Modified Peanut Proteins Ara h 1, Ara h 2, and Ara h 3

Interventions

E. Coli-Encapsulated, Recombinant Modified Peanut Proteins Ara h 1, Ara h 2, and Ara h 3 BIOLOGICAL

Up to 7 mL solution administered rectally

Also known as: EMP-123

EMP-123; EMP-123 in Peanut Allergics

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Allertein Therapeutics, LLC: lead
• Consortium of Food Allergy Research: collaborator

Study Sites (2)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Related Publications (2)

• 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.

  PMID: 19111571 BACKGROUND

• 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.

  PMID: 17689596 BACKGROUND

MeSH Terms

Conditions

Food Hypersensitivity; Hypersensitivity; Hypersensitivity, Immediate; Peanut Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases; Nut and Peanut Hypersensitivity

Study Officials

• Robert A. Wood, MD

  Johns Hopkins University

  STUDY CHAIR

• Scott Sicherer, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2009
• First Posted: February 25, 2009
• Study Start: October 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: May 27, 2013

Record last verified: 2013-05

Locations

US (2)