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UK COLLEGE OF MEDICINE SELECTED
AS SITE FOR SMALLPOX VACCINE
CLINICAL TRIAL

By Tammy Gay

Photo of UK Chandler Medical Center Chancellor James Holsinger, Richard Greenberg, M.D., Robert J. Hopkins of DynPort Vaccine Co. and Terry Irgens, president of DynPort Vaccine
UK Chandler Medical Center Chancellor James Holsinger, left, principal investigator Richard Greenberg, M.D., Robert J. Hopkins of DynPort Vaccine Co. and Terry Irgens, president of DynPort Vaccine spoke at today's news conference on a clinical trial of a new investigational smallpox vaccine.

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"The strain of vaccinia virus in the vaccine we will test is a derivative of the U.S. Army's strain previously tested by the DoD in a small number of volunteers. This study is the first to compare the previously licensed vaccine (the one used all during the past century) to the vaccine derived from the U.S. Army's strain and manufactured with modern cell-culture methodology."

-- Richard N. Greenberg, M.D., principal investigator and professor, UK College of Medicine

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April 26, 2002 (Lexington, Ky.) -- The University of Kentucky Chandler Medical Center officials announced today that UK is the exclusive site chosen to conduct the first Phase I clinical research trial for a new investigational smallpox vaccine for the Department of Defense (DoD).

The vaccine is being developed for the DoD through the Joint Vaccine Acquisition Program (JVAP). DynPort Vaccine Company LLC (DVC), a joint venture between DynCorp of Reston, Va., and Porton International Inc., is the prime contractor of JVAP and is responsible for developing, licensing and supplying biodefense vaccines required for the DoD.

"Interestingly, the smallpox vaccine that was used during the past century, the one everyone is reading about these days, and the new one we intend to test are made from vaccinia virus, a relative of the smallpox virus," said Richard N. Greenberg, M.D., principal investigator and professor in the UK College of Medicine.

"The strain of vaccinia virus in the vaccine we will test is a derivative of the U.S. Army's strain previously tested by the DoD in a small number of volunteers. This study is the first to compare the previously licensed vaccine (the one used all during the past century) to the vaccine derived from the U.S. Army's strain and manufactured with modern cell-culture methodology. "

Greenberg has significant, specific smallpox vaccine experience gained while working with the World Health Organization in India during the 1970s. UK was chosen as the study site because of Greenberg's expertise, and his interest in smallpox vaccine development and the professional reputation of its clinical research staff.

Approximately 150 volunteers, including students at the University and adults living in the Lexington area who have not been previously vaccinated, will be recruited for the study starting today. Greenberg said he hopes people who work in public safety occupations will be especially interested in seeing if they qualify to participate in the research, as smallpox is a serious bioterrorism concern.

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

DVC's smallpox vaccine is a derivative of the U.S. Army's vaccine strain previously tested by the DoD in clinical trials. It is produced using modern large-scale cell culture technology that has none of the extraneous animal byproducts present in the original smallpox vaccine produced more than 30 years ago. The last naturally occurring case of smallpox was reported in 1977 and the world was declared free of smallpox in 1980 as a result of smallpox vaccine.

To participate in the research study, participants must be between 18 and 30, healthy with no major medical conditions, willing to have blood stored for future testing and never have received the smallpox vaccine. In addition, volunteers will undergo a rigorous screening process, which includes a medical history and physical, to ensure they qualify to participate in the study. Medical personnel will engage in an informed consent process with each volunteer to ensure discussion of all aspects of the study.

As with any Phase I research study, the safety and well-being of the volunteers is a primary concern. The research study will randomly divide volunteers into two groups - 50 will receive the existing smallpox vaccine and the remaining 100 will receive the new DVC vaccine. A small drop of the vaccine will be applied to the skin on the upper arm and small needle sticks are made into the drop to transfer the vaccine into the skin.

Participants will be monitored for an hour after the vaccination in case of side effects such as allergic reactions. Development of a pock lesion at the site of vaccination provides evidence that the vaccination has produced an immune response.

Additionally, the volunteer's blood will be tested for antibodies that are specific to smallpox. All volunteers will be monitored and assessed with routine follow-up visits to the UK Medical Center for 180 days with 60 of the 150 volunteers being followed for three years.

During the study, neither the researcher nor the study participant will know which vaccine was administered until the study is complete.

Study participants will be compensated $25 per visit for 11 visits during the 180-day study. The participants to be followed for three years will receive an additional $100 stipend for each yearly visit.

"This is a significant step forward in our country's defense against bioterrorism," Greenberg said.

For more information, call UK Health Connection at (859) 257-1000 or (800) 333-8874.


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