Smallpox Vaccine Studies Swamped With Volunteers

http://www.washingtonpost.com/wp-dyn/articles/A59631-2001Oct26.html


By Amy Argetsinger
Washington Post Staff Writer
Saturday, October 27, 2001; Page B01

Before last week, the notion of volunteering her body
to science had never particularly appealed to Kathy
Tullier. Then she heard about a new clinical study of
the smallpox vaccine. She rushed to track down the
nearest research center, "ready, willing and able,"
she said, to offer herself up as a guinea pig.

Plus, the Annapolis mother of two hinted to
researchers, she could provide the services of a
couple of young teenagers, if need be.

In the past two weeks, hundreds of people have called
the University of Maryland School of Medicine and
three other research centers clamoring to sign on for
a   National Institutes of Health study of whether the
smallpox vaccine works in doses much smaller than
usual -- potentially a way to stretch the nation's
limited stockpile in case of a bioterrorist attack.

Most volunteers are hardly motivated by altruism, they
admit: They just want the vaccine. And they want it
now.

"I'm really worried about smallpox," said Tullier, a
46-year-old social worker, "and I'd love to have my
family protected."

With the emergence of anthrax this month, the once
vague threat of bioterrorism has solidified into a
dreaded reality. Now health officials and average
citizens alike find themselves losing sleep over the
prospect of smallpox, a disfiguring and deadly disease
last seen in this country more than half a century
ago.

An aggressive vaccination campaign virtually wiped
smallpox off the globe more than a generation ago, and
the United States stopped routine vaccinations in
1972. But experts have long suspected that Iraq, North
Korea and Russia may have secretly attempted to turn
the virus into a weapon -- and that terrorists could
try to get their hands on it.

The government has ordered millions of  doses of the
smallpox vaccine from drug companies. But with the
first fresh batch still months away from delivery, NIH
commissioned the  study to explore whether the
government's stockpile of 15.4 million doses could be
watered down to cover all Americans.

But even that contingency schedule isn't fast enough
for the worried people who are vying to join the
study. At St. Louis University School of Medicine,
researchers have fielded calls from as far away as
Connecticut and California. At the University of
Rochester School of Medicine, about 360 people have
attempted to volunteer for a trial that will enroll
170 -- a far higher volume of interest than for most
clinical trials.

Officials at Baylor College of Medicine in Houston,
the fourth research center in the trial, have received
a modest number of calls, but they noted that the
calls started coming in even before the school
solicited volunteers.

"People are hearing it from friends; they're hearing
it on the news," said Theresa Mowry, a nurse recruiter
at the University of Maryland's Center for Vaccine
Development. "We started getting calls before we had
our final approval" to run the study, she said.

Only a few of the volunteers have professed an
interest in helping science's fight against
bioterrorism, Mowry said. "Everybody's trying to
protect themselves," she said. "People are seeing this
can benefit them."

The surge of interest may seem surprising, especially
in Maryland, where human clinical trials haven't
gotten the greatest publicity lately. In June, a
healthy young volunteer died while taking part in a
study of an asthma drug at Johns Hopkins University,
prompting federal regulators to shut down medical
trials there for several days. Regulators also began
investigating an unrelated Hopkins study of lead
poisoning, in which researchers recruited poor
families to live in homes with varying degrees of
contamination.

Yet unlike many clinical trials, this one involves not
a mysterious new drug but a known quantity -- a
vaccine already given to millions of people living
today. "I knew what all the risks were," said Matt
Heironimus, 28, of Hazelwood, Mo., who volunteered for
an earlier round of the smallpox study last year.
"Until a few years before I was born, everybody got it
anyway."

But even those people who were vaccinated 30 or more
years ago have probably long since lost their
resistance, experts say, meaning that most of the
population could be vulnerable in an outbreak.

It's a fearsome prospect. Smallpox looms as a disease
of medieval horrors -- high fevers, hot rashes and
weeping sores that cover the body. One-third of its
victims die,  and survivors are scarred for life.
Unlike anthrax, which can be contracted only through
direct contact with spores, smallpox is highly
contagious, transferred through coughs, sneezes and
contaminated clothes and bedding.

Rising concerns about bioterrorism prompted a first
round of vaccine trials at St. Louis University two
years ago. In those trials, researchers dispensed the
vaccine in varying doses to three groups -- full
strength, a  1-to-10 dilution and a 1-to-100 dilution.
The weakest dose showed little success, said  Sharon
Frey, the lead researcher. But with the 1-to-10
dilution, 70 percent of test subjects showed a "take"
to the vaccine -- indicated by a blister that forms a
scab and leaves a scar.

The new trial will test 1-to-5 and 1-to-10 dilutions
on 684 adults. "It's possible if you have a reaction
to the vaccine, a good 'take,' it doesn't matter what
the dose was," Frey said.

For those who have never had it, the smallpox
inoculation process "is like no vaccine you've ever
seen," said  Carol Tacket, of Maryland's Center for
Vaccine Development. A short, two-tined needle is
dipped into the vaccine solution, then scratched just
under the surface of the skin of the upper arm several
times.

"The idea is to infect the cells of the skin with this
live virus," causing the body to produce antibodies
that will fight the disease, she said.

Even though the medical centers have been bombarded
with inquiries, they are still recruiting, because
many of the applicants have not met the criteria.
Volunteers must be adults in good health with no
history of smallpox vaccination or infection and who
do not have contact with pregnant women, infants or
people with eczema or immune system disorders.

Also, they must be between 18 and 32 -- which ruled
out Tullier and her children, much to her dismay.

"They better start mass-producing [the vaccine] right
away," she said. "I hope they get it out in time."