Shingles vaccine trial enters phase III at CC

The 11th floor day hospital was host to history on Thursday, June 17, when Dr. Philip Brunell of NIAID rolled up his sleeve to become the first to be immunized with an experimental vaccine to prevent shingles.

"I've been working on this problem for about 40 years," said Dr. Brunell, an internationally renowned pediatrician and expert on the varicella-zoster virus, the virus that causes chickenpox. "I have a very personal interest in this because zoster is much more common in older Americans and I include myself amongst them. With the hope that this vaccine will prevent or modify shingles, I am going to be the first to roll up my sleeve here at the NIH and get this vaccine."

Herpes zoster, commonly known as shingles, strikes about 500,000 .Americans every year. Caused by the same virus that causes chickenpox, it is characterized by a rash or blisters and extreme pain.

The clinical trial has progressed successfully and, with the immunization of Dr. Brunell, has entered phase III. This advanced stage of trial will further test the vaccine's safety and verify its ability to prevent the disease.

"This is an infection that occurs mostly in older Americans and, as our population ages, the likelihood that we will get shingles also increases," said Dr. Stephen Straus, chief of the laboratory of clinical investigation at NIAID.

Overall, people have a 20 percent chance of developing shingles in their lifetime. After a bout of chickenpox, the virus lies dormant in nerve tissue. The virus may reactivate, causing shingles later in life.

"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 Dr. Norberto Emilio Soto, principal investigator on the study.

The CC is one of 22 sites across the United States participating in this large-scale study, which allows all eligible Americans to participate.

The trial is unique in size. The research team hopes to vaccinate a total of 37,000 healthy people over age 60 at the sites, with the goal of preventing shingles through this vaccination. Locally, the CC hopes to recruit 1,800 volunteers.

"I think this is the largest vaccine study ever mounted in the United States," said Dr. Straus. "I think this is the largest study for the prevention of infectious disease ever done, and it's one of the largest studies ever done for the older population."

Irvin Cohen, a shingles sufferer, looked on as Dr. Brunell was vaccinated.

"I must say, I wouldn't wish the incident of shingles on my worst enemy because for the better part of two weeks, I was absolutely miserable," he said. "The discomfort is so intense at times that you almost wish that you don't wake up in the morning, and anything that can be done to mitigate that is certainly going to be appreciated, especially by the older population."

The NIAID experimental shingles vaccine research team is looking for healthy adults, ages 60 and over who have had chickenpox and never had shingles. Study participants will be required to make one outpatient visit to the CC, followed by monthly phone calls via a toll-free number for up to 5 years.

"We have assembled here at NIH a wonderful team of physicians and nurses who will be carrying out the study, and the success now depends on people over age 60 joining us and participating in this simple study," said Dr. Straus.

For more information about the study, please call the Clinical Center Patient Recruitment and Public Liaison Office at 1-800-411-1222. (by Bonnie Flock)


 

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