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When Dr. Norberto Soto sought out people to receive an experimental vaccine for shingles he thought it would be a difficult task. But it wasn’t. Within two years,
Dr. Soto’s team at the Laboratory of Clinical Investigation, National Institute of Allergy and Infectious Diseases recruited 1,741 individuals from the Washington metropolitan area and more than 38,000 people nationwide.
“I don’t think there’s ever been a vaccine study of this magnitude done in older adults at the Clinical Center,” said Dr. Soto, principal investigator for the Shingles Prevention Study. “It’s just really been amazing to be able to enroll this many people.”
The goal of recruiting a large test group was met through a mass media campaign, mailings and community outreach programs that involved going to senior communities to educate residents about the study.
The Patient Recruitment and Public Liaison office reports that the Clinical Center screened 3,515 participants, and referred 3,063 of them to the study team. Of those who were referred, 1,741 were selected to participate in the five-year study. Participants had to be healthy adults over age 60, who have never had shingles.
The Clinical Center was one of 22 recruitment centers nationwide.
The study is being conducted in collaboration with the Department of Veterans Affairs, NIAID and Merck & Company, Inc., the vaccine producer.
An estimated 600,000 to 1 million people develop shingles annually. The disease generally strikes people over the age of 50, but anyone who has had chickenpox is at risk of developing the disease. When a person gets chickenpox the bumps and scarring go away, but the virus causing the chickenpox lies dormant in nerve cells and can be reactivated as a person gets older, causing shingles.
The shingles vaccine is a modified version of the current chickenpox vaccine and is used to boost the immune system to protect people from developing shingles later in life. Shingles produces a painful outbreak on the skin. It usually occurs on one side of the body and a rash of fluid-filled blisters generally form on the face, chest or waist, according to Dr. Soto.
“It can be very painful,” said Rosemary McCown, RN, who along with Marilyn Kelly, RN, MS, served as study coordinators for the trial. “You may get a rash for two to three weeks, but the pain may never go away. It can stay with you the rest of your life.”
Prolonged pain caused by shingles, affects 20 percent of people with the condition. That rate increases to 40 percent in people over the age of 60. Other complications from shingles include irreversible hearing and vision loss, or permanent blind- ness if the disease develops on the face.
“We want to improve the health quality in these individuals,” said Dr. Soto. “Preventive measures and health maintenance is more effective than treating people once they are sick."