THE VACCINE
Study Tests Defrosted Smallpox Vaccine, Just in Case
By DENISE
GRADY
ASHVILLE,
Oct. 9 — Jesse Grey, a 24-year-old graduate student in chemistry at
Vanderbilt University, rolled up his sleeve today, and Dr. Kathryn
Edwards scrubbed his upper arm with a gauze pad soaked in acetone.
Then she unwrapped a fine needle with two tiny prongs on one end
and dipped it into a vial of greenish liquid, swished it around and
caught a drop between the prongs. Gently, she rubbed the liquid onto
a dime-size area on Mr. Grey's arm. Not so gently, she jabbed the
area 15 times, counting each jab out loud.
She had just vaccinated Mr. Grey against smallpox. It was the
first day of a government-sponsored test of smallpox vaccine, one in
a series of studies that began earlier this year, provoked by fears
that terrorists or a hostile country like Iraq has stocks of the
smallpox virus and might use it as a weapon. Given the potential
threat, many health officials say the United States, which ended
routine smallpox vaccination in 1972, must be ready to start it
again.
"I feel like I'm part of a frontier, stepping into a new era,"
Mr. Grey said. "Especially after 9/11. It's for the betterment of
the United States, and the world perhaps."
Healthy young men and women, including other graduate students
like Mr. Grey and some health workers who expected to be called on
to vaccinate others, waited their turns at the clinic. Fourteen were
scheduled for the first day of the study. Many of the volunteers,
like Mr. Grey, said part of their reason for participating was
simply to help researchers find out the best way to use the nation's
stockpile of vaccine, which has been frozen for decades. A few
volunteers said they were also lured by the $300 they would be paid
to complete the study. One said it would not hurt to be vaccinated
"just in case."
The United States stopped smallpox vaccinations in 1972 because
the disease had been wiped out in the Americas. Globally, it was
eradicated in 1980, and most other countries also stopped
vaccinating. An important part of the reason that countries
willingly gave up vaccination once the disease was no longer a real
threat is that the smallpox vaccine, more than any other vaccine,
carries a significant risk of serious complications.
For every million people vaccinate, 1 or 2 die, 15 suffer
life-threatening complications and hundreds of others have serious
skin rashes, infections or other problems.
By the end of this month, Dr. Edwards and her team at Vanderbilt
hope to have vaccinated 150 volunteers from 18 to 32 years old,
people who have never received the smallpox vaccine before. The
Vanderbilt study is part of a larger one, sponsored by the National
Institutes of Health, to include 150 volunteers from each the
University of Iowa and the University of Cincinnati.
The purpose of the study is to test the safety and effectiveness
of a smallpox vaccine, made by Aventis Pasteur, that has been frozen
since the 1970's. From 70 million to 90 million doses of the vaccine
are now available, and the new study will also help determine how
much those doses can be diluted to stretch the supply. Volunteers in
the study will receive the vaccine in one of three forms: full
strength, or diluted 1 to 5 or 1 to 10 in strength.
Over two months, researchers will gauge the effectiveness of the
vaccine by assessing sores and scabs at the vaccination site, a sign
that the vaccination has worked. They will also measure antibody
levels in the volunteers' blood at several intervals after the
vaccinations.
The researchers at Vanderbilt hope to have results to report to
the national institutes by Christmas.
Similar studies earlier this year found that the Aventis Pasteur
vaccine and another one, Dryvax, made by Wyeth, had retained their
potency despite being stored for so many years. But if diluted too
much they lose effectiveness, and further studies are needed to find
out the best way to use them.
The earlier studies also found that 20 percent to 30 percent of
the people who were vaccinated became sick enough with fever and
aches and pains to miss several days of work or school. All
recovered.
Volunteers for the study go through an extensive screening
process designed to exclude anyone who has a high risk of being
harmed by the vaccine. People at risk include those with organ
transplants, certain cancers, H.I.V. infection or other conditions
that might weaken their immunity. People with skin conditions like
eczema or atopic dermatitis — or even a history of them — are also
excluded. So are pregnant women.
People are also barred from the study if they live with someone
who might be endangered by the vaccine, including babies under a
year old. The reason is that the smallpox vaccine contains a live
virus, vaccinia, a relative of the smallpox virus, which could leak
out of the vaccination site and infect someone else.
As part of the Vanderbilt study, researchers will swab the
volunteers' bandages, hands and vaccination site, to find out
whether the virus is leaking out and posing a threat to others.
Researchers fear that today, complication rates may be higher than
they were in the past, because millions of people are now infected
with H.I.V., more people have organ transplants today, and rates of
eczema are higher than in the past.
Dr. Edwards, who has made a career of studying vaccines, said she
was worried that the public was not fully aware of the risks of the
smallpox vaccine.
She added, "What's really sad is to think that you eradicated an
infectious agent from the world — and we have patients with so many
other diseases like malaria and H.I.V. and tuberculosis — and now we
have to spend all this time on something we had already conquered."
Britain Stockpiles Vaccine
LONDON, Oct. 9 — Government officials said today that they were
stockpiling millions of doses of smallpox vaccine but that they did
not plan mass vaccinations unless there was a smallpox attack.
"Our position would be to ring vaccinate around the outbreak as a
first line of defense" and to inoculate the medical workers deployed
to treat patients, a spokeswoman for the Department of Health said.
Sir Liam Donaldson, the country's chief medical officer, said
there was no evidence of an increased risk of attack, but he told
the BBC that "we should have in place enough vaccine to vaccinate on
a mass population basis if necessary."
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