http://www.washingtonpost.com/wp-dyn/articles/A59631-2001Oct26.html
Smallpox
Vaccine Studies Swamped With Volunteers
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
By Amy Argetsinger
Washington Post Staff Writer
Saturday, October 27, 2001; Page B01
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."
© 2001
The Washington Post Company
ALL
INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR
GENERAL INFORMATION PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE
KNOWLEDGE OR OPINIONS OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED
AS PROVIDING MEDICAL OR LEGAL ADVICE. THE DECISION WHETHER OR NOT TO
VACCINATE IS AN IMPORTANT AND COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU
ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER.