Saturday, April 27, 2002

UK's medical center to test smallpox vaccine for military




By Steve Bailey
The Associated Press

        LEXINGTON — The University of Kentucky's Chandler Medical Center will be the exclusive test site for a new smallpox vaccine being developed for the U.S. Department of Defense.

        School officials made the announcement at a news conference Friday with representatives of DynPort Vaccine Co. LLC, which is responsible for developing, licensing and supplying biodefense vaccines for the military.

        “Smallpox is the king of bioterrorism,” said Dr. Richard Greenberg, the university's principal investigator on the trial and an infectious disease expert. “It's a rather devastating disease that is easily transmitted. Even if you don't die from it, it can make you very sick.”

        The study will evaluate the safety and effectiveness of the new DVC smallpox vaccine as compared with the vaccine used during the worldwide smallpox vaccination program in the 1970s.

        Researchers hope to recruit as many as 150 volunteers for the trial. One hundred volunteers will receive the new vaccine and 50 others will be given the existing vaccine.

        The last naturally occurring case of smallpox, a virus causing hundreds of swollen skin lesions, was reported in 1977 and the world was declared free of smallpox in 1980 as a result of smallpox vaccine.

        Since that time, however, fewer and fewer people have been vaccinated against the disease, a situation that could prove disastrous should it be used in a terrorist attack such as a suicide bombing.

        “It's important people understand how devastating this could be,” said Dr. James Holsinger, chancellor of the medical center. “You look at pictures of people who have had smallpox and you're instantly glad that it was conquered years ago.

        “To have to reface that particular concern in the 21st century is a devastating idea to people not just in America but around the world.”

        DVC's new smallpox vaccine is a derivative of the Army's vaccine previously tested in Department of Defense clinical trials. It is produced using modern large-scale cell culture technology that has none of the animal byproducts present in previous smallpox vaccines.

        If trials prove successful, the vaccine will be given to U.S. military personnel around the world, said Dr. Robert Hopkins, director of clinical trials for DynPort.

        “We hope to have the vaccine licensed by 2005,” Dr. Hopkins said. “That's when we will create a stockpile for the Department of Defense. Once that contract has been fulfilled, we will have the license to manufacture and distribute the vaccine worldwide.”

        To participate in the study, volunteers must be between 18 and 30, have no major medical conditions — especially any type of immunodeficiency problems — and never have received the smallpox vaccine.

        Volunteers will undergo a rigorous screening procedure, including a detailed medical history and physical examination.

        Participants will be compensated $25 per visit for 11 visits during the 180-day study. Some volunteers will be followed for another three years and receive an additional $100 per annual visit.

        Dr. Greenberg said dangers involved when testing new drugs and vaccines will be taken into consideration when screening volunteers.

        Theoretically, if one million people were vaccinated, researchers would expect a handful to die from complications and as many as 1,000 others to suffer side effects or develop the disease itself, Dr. Greenberg said.

        “That's why we've come up with such stringent screening procedures — to make sure we don't admit those who may be at higher risk,” he said.

        “Our hope and expectation is that we'll get through this with no complications, but you never know. Clinical research is just that — research. So every volunteer will have to decide for themselves the risks and benefits of participation.”

       



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