Smallpox Vaccine Study

Originally Released: October 11, 2001
Contact: Larry Roberts, lroberts@som.umaryland.edu, 410-706-7590
Ellen Beth Levitt, eblevitt@umm.edu, 410-328-8919

SMALLPOX VACCINE STUDY A TOP PRIORITY FOR UNIVERSITY OF MARYLAND CENTER FOR VACCINE DEVELOPMENT

Research Should Help Federal Health Officials Prepare for Bioterrorism Threat

At the request of U.S. health officials, the University of Maryland School of Medicine is participating in a multi-center study to measure the effectiveness of the existing smallpox vaccine, and determine whether the current vaccine supply can be diluted in order to make more doses. The study involving 680 adults will be conducted at the University of Maryland Center for Vaccine Development (CVD), and at three other academic medical centers.

"This study is now our highest priority," says Carol Tacket M.D., professor of medicine at the University of Maryland School of Medicine and leader of the study in Maryland. Study volunteers will receive either an undiluted vaccine, a dose one-fifth the strength of the existing vaccine, or one that is one-tenth as strong. "We will begin the smallpox study as soon as the protocol is reviewed and approved," says Dr. Tacket.

Smallpox is a viral disease that causes a skin rash and a high rate of serious illness and death. It is the only human infection to be eradicated worldwide. The last known case of smallpox occurred in 1977 in Somalia, and routine immunization has not been done in the U.S. for more than two decades.

"In the wake of the attacks of September 11th, we must be prepared for anything, and that includes the threat of bioterrorism," says Robert Edelman, M.D., professor of medicine and associate director for clinical research at the CVD. The U.S. government has 15.4 million doses of smallpox vaccine and has ordered 40 million more for delivery by the end of 2004. "If the current vaccine can be diluted and still provide adequate protection, it may be possible to increase the number of doses of existing vaccine, says Dr. Edelman.

The study is funded by the National Institute of Allergy and Infectious Disease (part of the National Institutes of Health), and also will be conducted at the St. Louis University School of Medicine, the University of Rochester School of Medicine and Baylor College of Medicine. The vaccine will be provided by the Centers for Disease Control.

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