Researchers at Vanderbilt University in Tennessee yesterday began tests in one of a series of experiments to determine how to handle 70 million to 90 million doses of Aventis Pasteur smallpox vaccine, which has been kept in frozen storage since the 1970s (see GSN, March 28).

Earlier studies in the series, orchestrated by the U.S. National Institutes of Health, have indicated that the vaccine is still potent, but researchers hope to further explore how much they can dilute it without compromising its effectiveness, the New York Times reported (see GSN, July 9).

“What’s really sad is to think that you eradicated an infectious agent from the world — and we have patients with so many other diseases like malaria and HIV and tuberculosis — and now we have to spend all this time on something we had already conquered,” said Kathryn Edwards, who heads the Vanderbilt study.

The Vanderbilt researchers plan to vaccinate 150 people between the ages of 18 and 32 years old by the end of the month, according to the Times.  The University of Cincinnati in Ohio and the University of Iowa are also testing 150 volunteers each.

Researchers have screened volunteers intensively to ensure they are not at increased risk from potential vaccine side effects, the Times reported (see GSN, Oct. 7).  Those who might live with someone at an increased risk, such as children under a year old, are also banned from the study because the virus used to make the vaccine poses infection risks.

The study should help determine the optimum concentration of the Aventis Pasteur vaccine to maximize the supply of doses without compromising safety or effectiveness, according to the Times (see GSN, April 1).  Each volunteer in the study is to be vaccinated with a dose that is either full, one-fifth or one-tenth strength, according to the Times (see GSN, March 29). 

Over the next two months, researchers plan to evaluate the effectiveness of each inoculation by examining the sores that form at the vaccination site — an indication that the vaccination has been successful, the Times reported.  Researchers also plan to evaluate antibody levels in the blood of several volunteers.  The Vanderbilt researchers hope to be able to present their findings to the National Institutes of Health before the end of December, according to the Times (Denise Grady, New York Times, Oct. 10).

For further information, see:

CDC Smallpox Information

Journal of the American Medical Association Background on Smallpox

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