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) for the treatment of peanut allergy.

ABSTRACT:

Background

Immunotherapy for peanut allergy may be limited by the risk of adverse reactions.

Objective

To investigate the safety and immunologic effects of a vaccine containing modified peanut proteins.

Methods

This was a phase 1 trial of EMP-123, a rectally administered suspension of recombinant Ara h 1, Ara h 2, and Ara h 3, modified by amino acid substitutions at major IgE-binding epitopes, encapsulated in heat/phenol-killed E. coli. Five healthy adults were treated with 4 weekly escalating doses after which 10 peanut-allergic adults received weekly dose escalations over 10 weeks from 10 mcg to 3063 mcg, followed by three biweekly doses of 3063 mcg.

Results

There were no significant adverse effects in the healthy volunteers. Of the 10 peanut-allergic subject

SUBMITTER: Wood RA 

PROVIDER: S-EPMC3663889 | biostudies-literature | 2013 Jun

REPOSITORIES: biostudies-literature