Landmark smallpox vaccine study underway

November 05, 2001

Volunteers are lining up this week to be vaccinated against smallpox, a once routine occurrence now considered extraordinary yet necessary because of recent events.

A total of 684 healthy individuals will participate in the study in an effort to increase the number of available doses from existing stocks of smallpox vaccine. Taking part are Saint Louis University, Baylor College of Medicine, the University of Maryland, and the University of Rochester Medical Center. The research study is part of an effort by the U.S. government to extend the supply of the vaccine in case the deadly virus is released as part of a bioterrorism attack. The nation has about 15 million doses on hand; millions more are being made by pharmaceutical firms but are not yet available.

The vaccine contains no smallpox virus, and doctors stress that there is no risk of developing smallpox from the vaccine. Indeed, prior to 1972, getting the vaccine was regarded as a harmless rite of passage: Schoolchildren received the vaccine, then went back to the classroom the same day and compared scabs later in the week. The dime-sized scar that nearly all U.S. citizens older than 32 carry on their upper arms or elsewhere on the body is proof that they received the vaccine as a child. The vaccine is the same one used as part of a worldwide immunization program that eradicated smallpox everywhere but in research laboratories by 1979, an effort led by Rochester alumnus D.A. Henderson.

Study participants are receiving the traditional smallpox vaccine or a diluted form of the vaccine, either one-fifth or one-tenth the traditional dose. Vaccine expert John Treanor, M.D., associate professor of medicine at the University of Rochester and the leader of the Rochester portion of the study, says the clearest sign of successful vaccination will be the development of a dime-sized blister where the injection is given. The blister will scab over and heal within a few weeks, leaving a well recognized scar.

After the initial immunization, patients will be seen every three or four days for at least two weeks as nurses check the condition of the blister or scab and change the bandage. The study will last about two months.

The research teams conducting the study are funded by the National Institutes of Health to develop and test new vaccines for a variety of illnesses, including flu, pneumonia, rotavirus, and whooping cough. The current study focusing on the effectiveness of a diluted form of smallpox vaccine is very similar to a study carried out by the researchers last year on a flu vaccine.
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University of Rochester Medical Center

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