NIAID Launches Major Step in Trial of Experimental Shingles Vaccine
On June 17, researchers at NIAID will join in a landmark study of an experimental vaccine to prevent shingles (also known as herpes zoster, or just "zoster"). In this Phase 3 trial, which is called the Shingles Prevention Study, 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 roll up his sleeve to become the first person to be immunized in the trial at the NIAID site. More than 1,000 people have been immunized so far at 20 other collaborating centers. The study is a Department of Veterans Affairs (VA) cooperative study representing a scientific collaboration between the VA, NIAID, and Merck & Co., Inc., the vaccine’s producer. It tests 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 says, "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," says Norberto Emilio Soto, M.D., NIAID's participating investigator on the study.
The national trial at 21 medical centers is recruiting a total of 37,000 volunteers, including 1,800 in the metropolitan Washington, D.C., area.
Volunteers Needed
People are invited to participate in this medical research study if they:
- are age 60 or older;
- have had chickenpox or have lived in the United States for the past 30 years;
- are in good general health – for example, do not have cancer, an immune deficiency, or depressed immunity; and
- have never had shingles.
Anyone interested in participating in the Shingles Prevention Study or obtaining further information should call toll-free 1-877-841-6251. The national chairman of the study is Michael N. Oxman, M.D., professor of medicine at the University of California at San Diego and staff physician at the VA Medical Center at San Diego, who may be contacted at 1-858-552-8585, extension 4638.
NIAID is a component 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. 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 http://www.niaid.nih.gov. For more information on vaccine research, please visit the NIAID vaccines publications page.
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