Vaccine Study to Target Bio-terrorism Threat

Smallpox Study at Saint Louis University Needs Volunteers

Recent global threats from terrorist groups have prompted U.S. officials to seek ways to protect American citizens against bio-terrorism and bio-\warfare.

Researchers at the Center for Vaccine Development at the School of Medicine have been asked to lead a study that will determine the safety and effectiveness of a vaccine that may protect humans against smallpox disease.

"Because of the recent concerns of terrorism throughout the world, the United States government is making efforts to improve its ability to protect its citizens in the event of an attack," said Sharon E. Frey, M.D., associate professor of infectious diseases and immunology and lead investigator in the study. The study is funded by the National Institutes of Health (NIH).

The world was declared free of smallpox in 1980 after routine vaccination proved effective. The vaccine, known as Dryvax, is no longer produced, but there is a limited supply available in the United States. The vaccine is kept by the Centers for Disease Prevention and Control (CDC) in Atlanta. Saint Louis University is the only site in the United States conducting the study at this time.

Frey said the study will focus on the effectiveness of diluted doses of Dryvax. Of the people enrolled in the study, one-third will receive the vaccine diluted 10 times. Another third will receive the vaccine that has been diluted 100 times. The final third will receive the full, undiluted dosage.

"Being able to dilute the vaccine would potentially increase the available stock by 10 to 100 fold," Frey said.

Approximately 60 volunteers will be needed in the St. Louis area. The requirements for inclusion in the study are that participants:

Should be 18-30 years of age, in good health, have no chronic illness and no history of serious allergic reactions.

Have no history of smallpox vaccination or infection.

Have no problems with their immune systems.

Have no contact with anyone who is pregnant, less than 12 months of age, has eczema or has problems with his or her immune system.

Researchers will exclude anyone who has an immune system problem, such as HIV/AIDS, cancer treatment and steroid medications. All volunteers will be compensated for participating in the study. For more information, call the Center for Vaccine Development at the School of Medicine at 577-8649.

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