On June 17, researchers at NIAID will launch an important next step in a study of an experimental vaccine to prevent shingles (also known as herpes zoster, or just "zoster"). In the so-called Phase III trial, the team will study the vaccine's safety and how well it works to prevent the disease.
Dr. Philip Brunell, an internationally renowned pediatrician and expert on the chickenpox virus, will officially open the trial by rolling up his sleeve to become the first person to be immunized with the experimental vaccine. The NIAID study will test a more potent version of the vaccine used to immunize children against the chickenpox virus. Earlier studies have shown the study vaccine to be safe and well tolerated.
At 68, Dr. Brunell believes strongly in the new vaccine's potential. "After almost 40 years of studying varicella-zoster virus," he said, "it is exciting for me to now be involved in testing this vaccine. Zoster, or shingles, is a very significant concern for those of us over 60, as the chance of getting it increases and the condition is often more severe as we grow older."
Shingles is a major health problem in older adults. Any individual has a 20 percent chance of developing it during his or her lifetime. Of the hundreds of thousands of people in the United States who will be diagnosed with shingles this year, most will be over age 60.
Shingles is caused by the same virus, varicella-zoster (VZV), that causes chickenpox. After a person has had chickenpox, VZV remains in the nerve cells by the spinal cord for life but is usually dormant. If it becomes reactivated, however, it can cause shingles. Early symptoms may include an outbreak of rash or blisters - usually on one side of the body or face - burning, tingling or shooting pain. Although skin symptoms may heal within weeks, the pain (called post-herpetic neuralgia) can be intense, severely debilitating and last for years. Other serious complications, such as blindness or hearing loss, may also occur.
As people who have had chickenpox age, their body's ability to suppress the virus is compromised, making them more susceptible to shingles. Once they have had shingles, they seldom have a recurrence, suggesting that the episode boosts immunity which then keeps the virus in check.
"We believe that by boosting the body's immune response with this vaccine - mimicking a naturally occurring case of zoster - shingles and post-herpetic neuralgia may be prevented," said Norberto Emilio Soto, M.D., principal investigator on the study.
The national trial of approximately 20 medical centers is recruiting a total of 37,000 volunteers - 1,800 in the metropolitan Washington, D.C., area - and is funded by the Veterans Administration, Merck & Co., and NIAID.
Volunteers Needed
People are invited to participate in this medical research study if they:
- are age 60 or older;
- have had chickenpox;
- are in good general health--for example, do not have cancer, an
immune deficiency or depressed immunity; and
- have never had shingles.
Those interested in participating or obtaining more information should call 1-800-411-1222. Extra copies of flyers for recruiting study participants, and fact sheets on shingles and the shingles prevention study, may be obtained by calling 1-800-772-5464 ext. 658. Media interested in attending the event on June 17 at the NIH Clinical Center should call the NIAID press office to make arrangements.
NIAID and the Clinical Center are components of the National Institutes of Health (NIH). NIAID conducts and supports research to prevent, diagnose and treat illnesses such as HIV disease and other sexually transmitted diseases, tuberculosis, malaria, asthma and allergies. The Clinical Center conducts clinical research on a wide variety of conditions including cancer, AIDS, mental illness and rare diseases. NIH is an agency of the U.S. Department of Health and Human Services.
Press releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at www.niaid.nih.gov.