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
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
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).
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
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.
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. "
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.
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
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.
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.
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.
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
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.
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.
the study, neither the researcher nor the study participant
will know which vaccine was administered until the
study is complete.
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.
is a significant step forward in our country's defense
against bioterrorism," Greenberg said.
information, call UK Health Connection at (859) 257-1000
or (800) 333-8874.