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Incidence and mortality of melanoma (skin cancer) in the United
States have risen steeply from 1969 to 1999.
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In one of the largest adult vaccine clinical trials ever,
researchers have found that an experimental vaccine against
shingles (zoster vaccine) prevented about half of cases of
shingles--a painful nerve and skin infection--and
dramatically reduced its severity and complications in
vaccinated persons who got the disease. The findings appear
in the June 2 issue of The New England Journal of Medicine.
The Shingles Prevention Study, conducted over 5 ?-years, was led
by the Department of Veterans Affairs (VA) and carried out in
collaboration with the National Institute of Allergy and Infectious
Diseases (NIAID), part of the National Institutes of Health (NIH),
and Merck & Co., Inc. (Whitehouse Station, NJ).
"This is very promising news for older persons," says Stephen E.
Straus, M.D., an infectious diseases specialist at NIAID and
Director of the NIH National Center for Complementary and
Alternative Medicine, who participated in the design, oversight and
conduct of the trial. "These striking results indicate for the first
time that we can use a vaccine to prevent shingles, one of the most
common and debilitating illnesses of aging. And among vaccine
recipients who did get shingles, the episodes generally were far
milder than they otherwise would have been."
"For some people, shingles can result in months or even years of
misery," comments study leader Michael N. Oxman, M.D., an infectious
disease specialist at the San Diego VA Healthcare System and the
University of California, San Diego.
Shingles, also known as herpes zoster, is caused by reactivation
of the virus that causes chickenpox. Once chickenpox infection has
run its course, the virus is not eliminated; rather, it retreats to
clusters of sensory nerve cells usually located near the spinal
cord, where the virus persists in a dormant state. As immunity
weakens with advancing age, the virus can reactivate, multiply in
and damage sensory nerve cells to cause pain. It then migrates to
the skin, causing the blistering rash of shingles.
Generally, shingles first manifests as pain, itching or tingling
in an area of skin on one side of the body or face. Then a painful
blistering rash develops in that same area of skin; the rash can
take two to four weeks to heal.
Anyone who has had chickenpox--which includes most adults in the
United States--could develop shingles, though not all will. The two
major risk factors are increasing age and declining immunity. Half
of all people who live to age 85 will get the disease. Experts
estimate more than a million new cases of shingles occur in the
United States each year.
The trial was conducted at 22 study sites nationwide, including
16 VA medical centers and six clinical research sites outside the VA
system coordinated through NIAID. Between November 1998 and
September 2001, the multicenter research team enrolled more than
38,500 men and women age 60 or older into the study. Half of the
participants received a single injection of the zoster vaccine--a
live, weakened form of varicella-zoster virus, the virus responsible
for chickenpox; the other half received a placebo vaccine. Neither
the researchers nor the participants knew who received vaccine and
who received placebo until after the study was over. The zoster
vaccine used in the study, manufactured by Merck, is a new, more
potent version of the chickenpox vaccine used to prevent chickenpox
in millions of American children every year since 1995. The zoster
vaccine was developed specifically for study in older adults.
During an average of more than three years of follow-up, the
vaccine reduced the incidence of shingles by 51 percent: 642 cases
of shingles occurred among those in the placebo group compared with
only 315 in the vaccinated group. Among all vaccine recipients, the
total burden of pain and discomfort due to shingles was 61 percent
lower than in placebo recipients. Moreover, the zoster vaccine
reduced the incidence of postherpetic neuralgia (PHN)--a form of
chronic nerve pain that is the most common serious complication of
shingles--by two-thirds compared with placebo. The vaccine was well
tolerated, with the rates of serious adverse events low and local
reactions at the vaccination site generally mild.
"As people live longer, and the proportion of older people in our
population increases, it is highly likely that the prevalence of
shingles will increase. A preventive shingles vaccine would be an
enormous boon for the health and quality of life of seniors," says
Anthony S. Fauci, M.D., NIAID director. "We are extremely gratified
that this public-private partnership has led to these exciting
results, which have the potential to greatly benefit seniors in
years to come."
Approximately 12 percent of older people with shingles experience
pain lasting for 3 months or longer (the definition of PHN used in
the study). As people age, however, shingles-associated nerve pain
increases in frequency and severity. This complication may occur in
nearly one-third of persons with shingles who are 60 years of age or
older.
Patients with PHN often describe the pain as burning, throbbing,
aching, stabbing or shooting, and it can cause both physical and
emotional suffering. What can be most distressing and debilitating,
according to these patients, is that at least 90 percent of them
have allodynia--pain caused by something that ordinarily is not
painful, such as clothing touching the skin, or a cool breeze.
Simply dressing and having a shirt touch the side of the body that
is affected can be excruciating.
Postherpetic neuralgia is difficult to treat. Antiviral
medications can speed the healing of shingles and reduce the
severity of nerve damage caused by the disease, but only if these
medications are used within 72 hours of the first sign of a shingles
rash. Thus, it is important for people to recognize the symptoms of
shingles and get to a doctor quickly. Antiviral medications do not
help relieve PHN once it has begun.
The researchers emphasize that the zoster vaccine was tested only
as a preventive therapy and is not intended as a treatment for those
who already have shingles or postherpetic neuralgia. On April 25,
Merck announced that it had submitted a license application to the
Food and Drug Administration for the zoster vaccine. If approved for
use, the research team estimates the vaccine could prevent 250,000
cases of shingles that occur in the United States each year and
significantly reduce the severity of the disease in another 250,000
cases annually.
The study was funded by the VA and by Merck, which supplied the
vaccine and placebo. The James R. and Jesse V. Scott Fund for
Shingles Research provided additional funds.
###
NIAID is a component of the National Institutes of Health, an
agency of the U.S. Department of Health and Human Services. NIAID
supports basic and applied research to prevent, diagnose and treat
infectious diseases such as HIV/AIDS and other sexually transmitted
infections, influenza, tuberculosis, malaria and illness from
potential agents of bioterrorism. NIAID also supports research on
transplantation and immune-related illnesses, including autoimmune
disorders, asthma and allergies.
Reference: MN Oxman et al. A vaccine to prevent herpes zoster and
postherpetic neuralgia in older adults. The New England Journal of
Medicine 352(22):2271-84 (2005).
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