The National Institutes of Allergy and Infectious Disease (NAID) seeks volunteers for a study of a vaccine to prevent shingles and to lessen the problems it causes.
The Shingles Prevention Study (SPS) is a major clinical research study aimed at preventing shingles and shingles-associated pain in otherwise healthy older Americans. This nationwide trial of an experimental vaccine is being conducted by the Department of Veterans Affairs in scientific collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and Merck & Co.
Each year, 600,000 to one million Americans are diagnosed with shingles. Anyone who has had chickenpox is at risk for shingles, though people over age 50 are at greatest risk. Once chickenpox resolves, the virus that caused it (called varicella-zoster virus, or VZV) retreats to nerve cells along the spinal cord, where it remains for life, usually dormant. As people age, their body's immunity to VZV wanes and the virus can then reactivate in the form of shingles. This process can also happen at any age as an effect of certain diseases or medications.
Typically, an episode of shingles begins with an unusual skin sensation itching, burning, pain, or sensitivity. A rash of fluid-filled blisters then develops, accompanied by pain that can be severe. The rash usually heals within several weeks, but 20 percent of shingles patients experience nerve pain that persists for months or even years and that can be so intense it interferes with simple activities of daily living. Other serious complications such as blindness may develop, especially if shingles occurs on the face.
Although there are medications that can ease some of the symptoms of shingles, they must be started early to be effective and they have little ability to prevent prolonged shingles pain. During the next 30 years, as the baby boom generation ages and joins the ranks of senior citizens, the need for a shingles vaccine will grow.
The vaccine being studied in the Shingles Prevention Study is a more potent form of the same vaccine routinely given to children to prevent chickenpox. Studies show that the vaccine used in this study can boost immunity to VZV. The goals of the SPS are to study how well the vaccine works to prevent shingles and to continue assessing its safety.
The study needs volunteers who are age 60 or older, generally healthy, and have NOT had shingles.
For more information about the study, please call: 1-800-411-1222. Extensive information can be found on the NIH shingles Web site http://www.niaid.nih.gov/shingles.
Information For Patients About the Shingles Prevention Study
The same virus that causes chickenpox in children causes shingles
later in life. The virus, called varicella-zoster, remains inactive
in the body after chickenpox has healed. If the virus becomes
active again it will cause shingles. The National Institute of
Allergy and Infectious Diseases (NIAID) is currently testing
a shingles vaccine in clinical trials at the National Institutes
of Health (NIH) Clinical Center in Bethesda, Maryland. Subjects
will receive either the experimental vaccine or the placebo.
For more information, call 1-800-411-1222.
How do I know if I am getting the vaccine or the placebo?
The shingles study is a double-blind study, meaning that
neither you nor your doctor will know which injection you are
receiving. You are selected to receive either one or the other
strictly by chance. At the end of the study you will be told
if you received the placebo or vaccine. If you were given the
placebo and the vaccine was found to be successful, you will
be offered the shingles vaccine at no charge at the conclusion
of the study.
What is the vaccine made of?
The NIH study will use a vaccine similar to that used to immunize
children against the chickenpox virus. The difference is that
the experimental vaccine will contain more of the weakened virus.
Can the vaccine be harmful to me?
Some people who have received the vaccine have had some
discomfort around the area of injection. In a small percentage
of people the vaccine may produce a low-grade fever. A detailed
description of possible side effects is included in the informed
consent form used in the study. Full time staff members are also
available to answer questions.
Is there anything I will have to do?
We will want to hear from you every month. A toll free
800 number will be provided to you when you come in to receive
the vaccine. When you call the number you will be asked a series
of questions which you can answer directly over the telephone
through a voice activated system. The information you provide
us is vital to the study outcome. Your responses will be monitored
and will help us determine if the vaccine is successful.
Will I get shingles if I receive the vaccine?
There is a chance the vaccine will not work for you.
If you think you are developing shingles it is very important
that you contact the study coordinator immediately. We will need
to examine you and run some tests. You will be given medication
and treatment at no charge. If you have shingles, you will need
to be seen by the doctor more frequently.