NIH assembles team to end smallpox vaccine threat

If it was ever necessary to conduct mass smallpox immunizations to protect the general populace, millions of people with atopic dermatitis would have to weigh the risk of smallpox vs. their potential fatal reaction to the vaccine.

The condition is called eczema vaccinatum (EV), a severe and potentially deadly complication of smallpox immunization. EV occurs almost exclusively in people with a history of atopic dermatitis (AD), a chronic, itchy skin condition commonly referred to as eczema. While uncommon, EV can develop when AD patients are given the smallpox vaccine or come in close personal contact with people who recently received the vaccine.

If untreated, EV can kill between 1% to 6% of those affected. In children younger than 2, EV has been estimated to kill up to 30%.

To address the problem, the National Institute of Allergy and Infectious Diseases (NIAID) has formed a nationwide research group. The recently formed network is comprised of three integrated components: a clinical studies consortium, an animal studies consortium, and a statistical and data coordinating center.

"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, MD, 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."

The Atopic Dermatitis and Vaccinia Network (ADVN) will try to determine why people with AD have such severe reactions to smallpox vaccine by evaluating their immune responses after natural exposure to less harmful skin viruses such as herpes simplex. The ADVN Animal Studies Consortium will establish animal models of AD 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 ADVN 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 AD patients.

The institutions in the ADVN Clinical Studies Consortium and principal investigators are:

  • National Jewish Medical and Research Center, Donald Leung, MD, PhD.
  • Oregon Health and Science University, Jon Hanifin, MD.
  • Children’s Hospital Boston, Lynda Schneider, MD.
  • University of California at San Diego, Richard Gallo, MD, PhD.
  • Johns Hopkins Asthma and Allergy Center, Lisa Beck, MD.
  • University of Bonn, Germany, Thomas Bieber, MD, PhD.

The institutions in the ADVN Animal Studies Consortium and principal investigators are:

  • Children’s Hospital Boston, Raif Geha, MD, and Hans Oettgen, MD, PhD.
  • National Jewish Medical and Research Center, Donald Leung, MD, PhD, and Erwin Gelfand, MD.
  • Harvard Skin Diseases Research Center, Thomas Kupper, MD, and Robert Fuhlbridge, MD.
  • University of Illinois at Chicago, Lawrence Chan, MD.
  • La Jolla Institute for Allergy and Immunology, Toshiaki Kawakami, MD, PhD.

The Statistical and Data Coordinating Center will be operated by Rho Federal Systems Division. The principal investigator is Susan Lieff, PhD.