Consortium for Food Allergy Research (CoFAR)

Coordinating Center
Project Status
Active
Project Lifespan
06/30/2005
Objective

CoFAR conducts basic clinical and epidemiological studies to investigate food allergies, develop treatment strategies, and elucidate the underlying mechanism in the development of food allergy. The specific aims of the Statistical and Clinical Coordinating Center (SACCC) are to support the coordination of study activities including: meeting support; protocol development and coordination; web-based centralized data management and information dissemination; regulatory support; pharmacy support; safety monitoring; analytical support for all clinical trials and observational studies.

Population

In July 2006, we began enrollment into our first study which is an observational study of food allergy. The study is researching the development of peanut allergy in infants (3 to 15 months in age) with known milk or egg allergy. This study is now closed to enrollment.

A second study, Egg Oral Immunotherapy, was opened in July 2007. This 2 year treatment study is investigating the outcome in egg allergic individuals (6 to 18 years) who receive a powdered egg product or placebo by mouth. This study is now closed to enrollment.

A third study, Peanut Sublingual Immunotherapy, was opened in April 2008. This 4 year treatment study is investigating the outcome in peanut allergic individuals (12-40 years) who receive a liquid peanut product or placebo under the tongue. This study is now closed to enrollment.

A fourth study, EMP-123, was opened in March 2009. This is a 7 month first in human Phase I trial investigating the safety and possible side effects of a peanut vaccine in healthy volunteers first and then in peanut allergic subjects (18-40 years). This study is open to enrollment.

Phase
I
II
III
Centers

Mount Sinai Medical Center
Duke University Medical Center
Johns Hopkins University
National Jewish Health
University of Arkansas for Medical Sciences

Products
AdvantageEDC
GlobalTrace
Regulatory Tracking System
Services
Data Analysis and Reporting
Independent Data and Safety Monitoring Board Services
Medical Monitoring
Meeting Coordination and Support
Protocol Monitoring
Project Management
Regulatory Affairs
Statistical Leadership and Project Management
Study Design/Protocol Development
Subject Recruitment
Training and Certification
Web-based Data Collection and Reporting Systems