Landmark Smallpox Vaccine Study Underway; Volunteers Still Needed

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.

The University of Rochester Medical Center is one of four institutions nationwide that the Federal government has turned to in an effort to increase the number of available doses from existing stocks of smallpox vaccine. 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.

Approximately 200 individuals in the Rochester area who have never been vaccinated will participate in the research study at Strong Memorial Hospital, part of a total of 684 healthy individuals who are participating nationwide.

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 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.

Though more than 400 people have called to ask about taking part in the study, many more volunteers are still needed, says Treanor.

Anyone interested in volunteering must be in good health, between the ages of 18 and 32, and must never have been vaccinated against smallpox. Volunteers also cannot have eczema or a condition that weakens the immune system. Prospective participants are excluded if they have daily close contact with a woman who is pregnant or with children under one year of age. Women who are pregnant or breastfeeding are not eligible.

Participants who qualify will be paid $25 per visit, with eight visits scheduled, and parking will be free.

Anyone interested in volunteering for the study should call (716) 273-3990.

Other institutions taking part in the study are Saint Louis University, Baylor College of Medicine, and the University of Maryland. The group comprises a network of research centers 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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