and scars: Diary of a smallpox vaccine trial
student's experience after receiving the controversial smallpox
October 10, 2003
the days following 9/11 I didn't know what to do. In fact, I didn't
do anything. Nine months later, however, I heard that Vanderbilt
Medical Center was looking for subjects for a study to text smallpox
vaccine study and it something finally clicked: Here was a way that
I could help. Instead of sending money or blood, I would let my
antibodies do the work.
The information gained from this study could save American lives
in the future. There was a more tangible compensation as well: As
a college student attempting to accumulate the least amount of loans
while completing my degree, the monetary payment for participating
in the study was also attractive.
When I informed my parents
of my intent, they expressed a degree of concern that surprised
me. I did not expect this reaction from a chemistry teacher and
nurse. But they did have some basis for alarm. Smallpox is the longest-lived
human pathogen in history. It begins like any other virus with symptoms
of headache, fever and nausea. Soon the skin turns scarlet and a
rash of red spots appears. The spots turn into blisters, then yellow
pustules and then scabs - if you are lucky. The unlucky 40 percent
die. The survivors live on scarred, many without their eyesight.
I explained to
my parents that the smallpox vaccine being tested is made from the
bovine version of the virus. Contracting this weaker strain does not
put human lives at risk. Yet the similarities between the two strains
are enough to build immunity against the deadly human variety.
micrograph reveals the histologic changes in human skin
that has been infected with the smallpox variola virus
Before deciding to join the study, I did some research
to learn more about smallpox today. I found that two known sources
of the human virus exist in the world. Colonies of the virus are
frozen in liquid nitrogen In a government laboratory in Atlanta,
where the vials lie under constant electronic surveillance. In Moscow,
another set of frozen vials stand guarded by police around the clock.
Since 9/11, many fear smallpox as the next biological warfare agent.
This raises serious questions: How secure are the facilities in
Atlanta and Moscow? In the event of a terrorist attack, will U.S.
health officials be prepared for action?
of Mad Cow Morning News
Smallpox vaccination policies in the event of a
biological attack have become a hot topic. The year 1972 marked
the last vaccination of children against smallpox in the United
States. Citizens under 30 (half the population) have never received
vaccinations. For those vaccinated, it is uncertain how long immunity
lasts. The available quantity of smallpox vaccine is inadequate
for the entire U.S. population and no manufacturers are currently
equipped to produce smallpox vaccine in large quantities. Frozen
for over thirty years, the current vaccine's viability was uncertain.
smallpox vaccine study examined the two frozen stocks of vaccine that
the federal government possesses. One stock, known as Dryvas, has
been stored at the Centers for Disease Control in Atlanta. Aventis,
the other stock, was created for the military but never tested due
to the eradication of smallpox in the 70's. The goal of the study
was to determine if the Dryvas vaccine is safe and if both Aventis
and Dryvas can be diluted without compromising their effectiveness.
If diluted to a one-tenth solution, existing stocks of vaccine could
protect the entire nation.
by Dana Johnson
To qualify for the study, I first had to pass a
physical. It consisted of the typical routine: height, weight, blood
pressure, temperature, blood and urine samples. During the physical
examination, Kathryn Edwards, the professor of pediatrics who headed
up the study, asked me to take my shoes and socks off. Surprised,
I complied. She surveyed on my hands, feet, arms or legs for any
skin disorders, explaining that individuals with an existing skin
condition such as dermatitis, impetigo or shingles are at greater
risk when receiving the smallpox vaccine.
On vaccination day I gave
another blood sample, and, along with the other women, provided a
urine sample for a pregnancy test. The participants all congregated
in a lunch break room. We finished filling out the consent forms,
and nervously waited. Individuals left when called by name and then
trickled back, bandages on their arms. When called to get my inoculation
I entered a small, closed-in room with a nurse and Dr. Edwards. Colorful
children's posters hung on the walls. The nurse used a computer to
randomly assign the vaccine stock for me to receive. No one in the
room knew which stock or dilution of the virus I received and against
which my body’s immune system would soon be waging war.
One, two, three, four, five..." Edwards counted
aloud while jabbing a pronged needle in my left upper arm. At first,
it felt like a pinprick but by the count of nine it began to hurt.
I listened to her steady counting, begging for the end to come quickly.
Unlike any vaccine I had received before, Dr. Edwards rubbed the
clear liquid on my skin instead of injecting it into the blood stream.
The fifteen punctures were to ensure proper interaction between
my body and the vaccine.
The July air hung heavy
with humidity when I stepped outside Vanderbilt's Medical Center North.
I clutched in my hand a diary card, care instructions, bandage change
kit and digital thermometer. Every day I must record my temperature,
symptoms and any medications taken. Most importantly, I must take
caution not to contaminate myself or others.
by Dana Johnson
One of the biggest surprises I got was the public
reaction. Strangers would come up to me on the street to ask, "What
happened to your arm?" One stranger went so far as to actually
poke the bandage, which was not only embarrassing, but quite painful.
The bandage was quite visible when
I wore short sleeves. The bright white non-stick gauze patch was 1.5
inches square and stood out against my summer-toned skin. The clear,
slightly larger, waterproof plastic sheet covering the gauze brought
more attention by its sheen. Underneath the bandage, the vaccine was
reacting with my skin. My body responded by forming a blister. The
blister and the fluids in it contain the live virus. I couldn't remove
the bandage, even for showers, because if any fluid transferred to
another location the virus would spread.
by Dana Johnson
A week after the vaccination, my arm began to hurt: Not just at the
inoculation site, but my entire shoulder. Shooting, burning pains
traveled across my shoulder, back and neck. The pain hit intensely
and unpredictably, producing headaches. For the first time I began
to doubt my decision to participate in the study. Though informed
of possible pain, soreness, redness and swelling at the vaccination
site, the intensity of the effects surprised me. But it was too late
to turn back.
On each of my return
visits to the clinic, a nurse removed the bandage to measure and photograph
the blister underneath. Air against my skin felt wonderful, my skin
begged to breathe underneath the shiny plastic bandage. But within
a couple minutes they sent me on my way, arm covered again. Occasionally
blood was drawn to examine antibody levels, which is the only method
to determine if the vaccine dilution was strong enough to cause my
body to react. About two weeks after the vaccination, all pain and
headaches subsided. My blister began the process of scabbing, and
with each visit I hoped the scab had fallen off. Only then could my
bandage be removed permanently.
Fourteen months after my immunization I now have
a dime-sized scar on my left shoulder, antibodies in my blood and
$375 in the bank. Three small blisters resulted in an asymmetrical
scar the deep red shade of skin healing itself. Instead of being
asked about the patch on my arm, people now ask me about the scar.
Discussing the personal choice I made with strangers
is still awkward. Many don't understand my decision, and I struggle
to explain. But I finally figured out what to tell them. Medical
researchers do all they can with animal subjects, but without human
volunteers, they cannot bring new medicines and vaccines to market.
November, President Bush approved preemptive smallpox vaccination
of one million U.S. military personnel and civilian medical workers.
My involvement in the study helped to make these vaccinations as
safe as possible. Though I experienced pain and discomfort, in the
long run, science and society gained some valuable knowledge. That
is worth the inconvenience of strangers stopping me on the street.
debate carries Vanderbilt voices
tests smallpox vaccine to protect nation
to participate in NIH-funded bioterrorism defense consortium