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Randomized Controlled Trial
, 197 Suppl 2 (Suppl 2), S228-36

Vaccination Against Herpes Zoster and Postherpetic Neuralgia

Collaborators, Affiliations
Randomized Controlled Trial

Vaccination Against Herpes Zoster and Postherpetic Neuralgia

Michael N Oxman et al. J Infect Dis.

Abstract

Background: Herpes zoster (HZ) and postherpetic neuralgia (PHN) cause significant morbidity in older adults. The incidence and severity of HZ and PHN increase with age in association with an age-related decline in varicella-zoster virus (VZV)-specific cell-mediated immunity (VZV-CMI). VZV vaccines can boost VZV-CMI. Therefore, we tested the hypothesis that VZV vaccination would protect older adults against HZ and PHN.

Methods: We enrolled 38,546 adults > or =60 years of age in a randomized, double-blind, placebo-controlled trial of an investigational HZ vaccine and actively followed subjects for the development of HZ. The primary end point was the burden of illness due to HZ (HZ BOI), a composite measure of the incidence, severity, and duration of pain and discomfort caused by HZ. The secondary end point was the incidence of PHN.

Results: Subject retention was >95%. HZ vaccine reduced the HZ BOI by 61.1% (95% confidence interval [CI], 51.1%-69.1%; P<.001) and reduced the incidence of PHN by 66.5% (95% CI, 47.5%-79.2%; P<.001). The incidence of HZ was also reduced by 51.3% (95% CI, 44.2%-57.6%; P<.001). HZ vaccine was well tolerated; injection site reactions were generally mild. HZ vaccine neither caused nor induced HZ.

Conclusion: The Shingles Prevention Study demonstrated that HZ vaccine significantly reduced the morbidity due to HZ and PHN in older adults.

Figures

Figure 1
Figure 1
Herpes Zoster (HZ) Severity-of-Illness Score. This is an example of the HZ Severity-of-Illness Score for a hypothetical subject with HZ. The HZ Severity-of-Illness Score is defined as the area under the curve of Zoster Brief Pain Inventory (ZBPI) “worst pain in the last 24 h” scores over time during the 182-day period after HZ rash onset.
Figure 2
Figure 2
Diagrams illustrating the behavior of the herpes zoster (HZ) Burden of Illness (HZ BOI) under 3 different theoretical circumstances. A, Behavior of the HZ BOI if the HZ vaccine were to reduce the incidence but not the severity of HZ, in which case there would be fewer cases of HZ in the vaccine recipients than in the placebo recipients, but the cases of HZ in the vaccine recipients would have, on average, HZ Severity-of-Illness Scores comparable to those of the cases in placebo recipients. B, Behavior of the HZ BOI if the HZ vaccine were to reduce the severity but not the incidence of HZ, in which case there would be just as many cases of HZ in the vaccine recipients as in the placebo recipients, but the cases of HZ in the vaccine recipients would have, on average, lower HZ Severity-of-Illness Scores than those in the placebo recipients. C, Behavior of the HZ BOI if the HZ vaccine were to reduce both the incidence and the severity of HZ, in which case there would be fewer cases of HZ in the vaccine recipients then in the placebo recipients, and the cases of HZ in the vaccine recipients would have, on average, lower HZ Severity-of-Illness Scores than those in the placebo recipients. In all 3 situations, the HZ BOI would be lower in the vaccine recipients than in the placebo recipients. The figures shown for the HZ Severity-of-Illness Scores and for the HZ BOI are for purposes of illustration only.
Figure 3
Figure 3
Herpes zoster (HZ) vaccine efficacy for the HZ Burden of Illness (HZ BOI). The primary end point of the Shingles Prevention Study was the HZ BOI, a severity-by-duration measure of the total pain and discomfort associated with HZ in the population of study subjects. For each confirmed case of HZ, responses to the “worst pain in the last 24 ” question in the Zoster Brief Pain Inventory were used to calculate an HZ Severity-of-Illness Score, defined as the area under the curve of HZ pain and discomfort plotted against time during the 182-day period after the onset of HZ rash. Subjects with HZ had HZ Severity-of-Illness Scores ranging from 0 to 1813. Increasing HZ Severity-of-Illness Scores are highly correlated with a decrease in the health-related quality of life and in functional status of older adults [44]. An HZ Severity-of-Illness Score of 0 was recorded for subjects in whom HZ did not develop during the study period. The HZ BOI Score represents the average HZ Severity-of-Illness Score among all subjects in the vaccine or placebo groups; it was calculated as the sum of the HZ Severity-of-Illness Scores of all members of a group divided by the total no. of subjects in the group. The figure is based on data published in [18].
Figure 4
Figure 4
Herpes zoster (HZ) vaccine efficacy for the incidence of postherpetic neuralgia (PHN). HZ vaccine significantly reduced the incidence of PHN, by approximately two-thirds, in all subjects and in both age strata. It is important to note that this reduction is among all subjects and not just those with HZ. The figure is based on data published in [18].
Figure 5
Figure 5
Herpes zoster (HZ) vaccine efficacy for the incidence of HZ. HZ vaccine significantly reduced the overall incidence of HZ, by 51.3%, although vaccine efficacy for the incidence of HZ was reduced substantially in subjects ⩾70 years of age. The figure is based on data published in [18].

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