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Safety of the Vaccine to Prevent Shingles FREE

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The summary below is from the full report titled “Safety of Herpes Zoster Vaccine in the Shingles Prevention Study. A Randomized Trial.” It is in the 4 May 2010 issue of Annals of Internal Medicine (volume 152, pages 545-554). The authors are M.S. Simberkoff, R.D. Arbeit, G.R. Johnson, M.N. Oxman, K.D. Boardman, H.M. Williams, M.J. Levin, K.E. Schmader, L.D. Gelb, S. Keay, K. Neuzil, R.N. Greenberg, M.R. Griffin, L.E. Davis, V.A. Morrison, and P.W. Annunziato, for the Shingles Prevention Study Group.

Ann Intern Med. 2010;152(9):I-20. doi:10.7326/0003-4819-152-9-201005040-00001
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What is the problem and what is known about it so far?

Herpes zoster (also called “shingles”) is a condition in which painful blisters develop on the skin along the path of a nerve. The blisters or rash usually occur in a localized area on one side of the body. Shingles results from infection with the varicella zoster virus, which is the same virus that causes chickenpox. After chickenpox, the virus remains inactive in nerves. Years later, shingles may develop when the virus becomes active during periods of illness or stress. The blisters are a sign that the “reactivated” virus has traveled from the nerves out to the skin.

People usually recover from shingles in a few weeks, but up to one fifth (20%) of people with shingles develop lasting pain in the affected area. This pain is known as “postherpetic neuralgia.” It can be severe and chronic. Shingles and postherpetic neuralgia become more common with older age. A large clinical trial, the Shingles Prevention Study, showed that the herpes zoster virus vaccine reduces the occurrence of shingles in people aged 60 years or older. Some people may not get the vaccine, however, because they fear adverse side effects.

Why did the researchers do this particular study?

To study the safety of the herpes zoster vaccine in older adults.

Who was studied?

38 546 adults older than 60 years who had participated in a large vaccine trial. Most had a history of chickenpox, but none had had shingles. Also, 6616 of the adults took part in a substudy in which they gave detailed information about adverse events.

How was the study done?

The researchers recruited older adults without serious illness or weakened immune systems from 22 academic centers in the United States. Adults were randomly assigned to receive 1 dose of vaccine or placebo. Staff injecting the solution under the skin knew what they were administering, but neither the patients nor the researchers who assessed adverse events were told which patients received vaccine or placebo. The researchers asked patients to report serious adverse events and followed them for about 3 years. About 300 adults from each study center also completed detailed “vaccination report cards.” The cards prompted them to report all adverse events (for example, fever, inoculation-site problems, rashes, worsening or new illnesses) that occurred during the first 42 days after inoculation.

What did the researchers find?

Few and equal numbers of vaccine and placebo recipients in the large trial reported serious adverse events (1.4%). More vaccine recipients (48%) reported inoculation-site side effects, such as redness, swelling, and tenderness, than did placebo recipients (16%). Inoculation-site side effects were more common in persons aged 60 to 69 years than in those older than 70 years.

What were the limitations of the study?

The researchers did not always review medical record data from facilities outside of their own medical centers to confirm the reported serious adverse events. Participants in the substudy were not randomly selected.

What are the implications of the study?

Herpes zoster vaccine causes minor local inoculation-site adverse effects but probably causes no more serious adverse events than does placebo.





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