As part of a nationwide research project that seeks to reduce the risk of eczema vaccinatum (EV), a severe and potentially deadly complication of smallpox immunization, the University of California, San Diego (UCSD) is seeking patients with atopic dermatitis, or psoriasis, for a new clinical trial. Participants will be evaluated for their immune responses in normal conditions and after natural exposure to less harmful skin viruses such as herpes simplex. Enrollment will open in August 2004. Information is available to those calling 858-642-3504.
The clinical trial is one component of the Atopic Dermatitis and Vaccinia Network, a nationwide research group that will conduct clinical trials with human subjects, animal studies, and include a statistical and data coordinating center. The project is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
The project coordinators note that EV occurs almost exclusively in people with a history of atopic dermatitis, which is a chronic, itchy skin condition commonly referred to as eczema. While uncommon, EV can develop when atopic dermatitis patients are given the smallpox vaccine or come into close personal contact with people who recently received the vaccine. If untreated, EV can kill between 1 to 6 percent of those affected. In children younger than 2 years of age, EV has been estimated to kill up to 30 percent.
“Millions of Americans have a history of atopic dermatitis,” says Anthony S. Fauci, M.D., director of NIAID. “Launching this network is an important step toward our goal of helping to protect everyone against smallpox virus without the risk of life-threatening complications.”
“Previous studies suggest that both innate and adaptive immunity are impaired in patients with atopic dermatitis, but the specific defects that increase the likelihood of eczema vaccinatum have yet to be explained,” says Daniel Rotrosen, M.D., director of NIAID's Division of Allergy, Immunology and Transplantation. “The information generated by this network will improve our understanding of the immune responses of these patients and should greatly influence the design of a safer smallpox vaccine.”
In addition to UCSD’s clinical trial and basic research component, which is under the direction of Richard Gallo, M.D., Ph.D., and co-director Tissa Hata, M.D., clinical trials will be held at Johns Hopkins Asthma and Allergy Center, Oregon Health and Science University, Children’s Hospital Boston, National Jewish Medical and Research Center, and the University of Bonn, Germany. The animal studies portion of the project will establish animal models of atopic dermatitis and investigate their immune responses to vaccinia—the virus used in smallpox vaccine—and other skin viruses such as varicella, which causes chickenpox and shingles. The statistical and data coordinating center will support these clinical and animal studies by analyzing research data, coordinating trials and regulatory activities, and developing and maintaining a registry of atopic dermatitis patients.
Press releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov
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