Topics

Peanut Allergy Vaccine Study in Healthy and Peanut-allergic Adults

2014-08-27 03:24:02 | BioPortfolio

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.

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Food Hypersensitivity

Intervention

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

Location

Johns Hopkins Univeristy
Baltimore
Maryland
United States
21205

Status

Recruiting

Source

National Institute of Allergy and Infectious Diseases (NIAID)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:24:02-0400

Clinical Trials [1549 Associated Clinical Trials listed on BioPortfolio]

Peanut Oral Immunotherapy

This is a study in which increasing amounts of peanut flour are given to the children who are peanut allergic to desensitize them to peanut. The hypothesis is that the peanut allergic pati...

Take Away Food Allergy; Inducing Tolerance in Children Allergic to Peanut

The purpose of the study is to identify prognostic markers and possible success rate of tolerance induction to peanut allergens in children allergic to peanut.

Peanut Sublingual Immunotherapy

The purpose of this study is to evaluate the safety and immune response to daily sublingual (under the tongue) immunotherapy (SLIT) with peanut extract in adults and children with peanut a...

Mucosal Immunotherapy for Peanut Allergy in Young Children

Peanut allergy is known to cause severe anaphylactic reactions.The goal of this proposal is to produce a new treatment that would benefit young subjects who have recently been diagnosed wi...

Double Blind Peanut Sublingual Immunotherapy

The specific aim of this study is to desensitize peanut-allergic subjects with peanut allergen-specific, sublingual immunotherapy (SLIT) by placing drops of peanut protein under the tongue...

PubMed Articles [15176 Associated PubMed Articles listed on BioPortfolio]

Peanut Allergy in Spanish Children: Comparative Profile of Peanut Allergy versus Tolerance.

Peanut storage proteins (Ara h 1, Ara h 2, and Ara h 3) have been described as the major peanut allergens in children, although not all peanut-sensitized individuals have clinical reactivity after exp...

Peanut allergen reduction and functional property improvement by means of enzymatic hydrolysis and transglutaminase crosslinking.

Enzymatic processing could reduce the allergenicity of peanut proteins while may lose the functional properties. Transglutaminase (TGase) is an enzyme for improving the functional properties of protei...

Defining the targets for the assessment of IgE-mediated allergenicity of new or modified food proteins.

Many food innovations rely on the introduction and use of new or modified proteins. New or modified food proteins may lead to major health risks due to their inherent potential to cause food allergy. ...

Peanut protein-polyphenol aggregate complexation suppresses allergic sensitization to peanut by reducing peanut-specific IgE in C3H/HeJ mice.

Peanut allergy is usually lifelong and accidental exposure impose formidable risk. The aim of this study was to assess the capacity of peanut proteins complexed to polyphenol extracts to reduce allerg...

Epicutaneous Exposure to Peanut Oil Induces Systemic and Pulmonary Allergic Reaction in Mice.

The prevalence of peanut allergy (PA) is constantly on the rise. Atopic dermatitis (AD) is a major risk factor for developing food allergy. Some bath oils and skin creams used for treating AD contain ...

Medical and Biotech [MESH] Definitions

Allergic reaction to tree nuts and peanuts, including other LEGUMES, that is triggered by the immune system. It includes co-sensitization to other food (e.g., sesame seed).

Food derived from genetically modified organisms (ORGANISMS, GENETICALLY MODIFIED).

Allergic reaction to peanuts that is triggered by the immune system.

Digestive system disorder where a particular food irritates the digestive tract or cannot be properly digested (i.e., due to a lack of a digestive enzyme). It differs from FOOD HYPERSENSITIVITY which is an immune system disorder, usually due to specific proteins in food. http://my.clevelandclinic.org/health/articles/problem-foods-is-it-an-allergy-or-intolerance.

A verocytotoxin-producing serogroup belonging to the O subfamily of Escherichia coli which has been shown to cause severe food-borne disease. A strain from this serogroup, serotype H7, which produces SHIGA TOXINS, has been linked to human disease outbreaks resulting from contamination of foods by E. coli O157 from bovine origin.

More From BioPortfolio on "Peanut Allergy Vaccine Study in Healthy and Peanut-allergic Adults"

Quick Search

Relevant Topics

Nutrition
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Allergies
The term allergy is used to describe a response, within the body, to a substance, which is not necessarily harmful in itself, but results in an immune response and a reaction that causes symptoms and disease in a predisposed person, which in turn can cau...


Searches Linking to this Trial