Safety, tolerability, and immunogenicity of zoster vaccine in subjects with a history of herpes zoster.
ABSTRACT Prior clinical studies of zoster vaccine enrolled subjects without a history of herpes zoster (HZ), so there are limited data on safety and immunogenicity in vaccinees with a prior history of HZ. This study was conducted to evaluate the safety and immunogenicity of zoster vaccine recipients who had a prior episode of HZ.
A total of 101 subjects > or = 50 years of age with a prior history of HZ were enrolled. They were stratified by number of years since their HZ (5 to 9 years and > or = 10 years, in an approximate 2:1 ratio), and randomized 1:1 to one of two vaccination groups. On day 1, Group I was administered zoster vaccine and Group II received placebo. At week 4, Group I received placebo and Group II received zoster vaccine. Subjects were followed for adverse experiences (AEs), exposure to varicella or HZ, and development of any varicella/varicella-like or HZ/HZ-like rashes, for 28 days after each injection. Blood samples were obtained prior to study injection on day 1 and week 4, and at week 8. Serum was assessed for varicella-zoster virus (VZV) antibody concentration by glycoprotein enzyme-linked immunosorbent assay.
No serious AEs were reported within the 28-day safety follow-up period following any vaccination. Although a higher percentage of subjects reported injection-site AEs after receiving zoster vaccine than did placebo recipients, the proportion of subjects reporting systemic clinical AEs was similar in both groups. Zoster vaccine induced a VZV antibody response at 4 weeks post-vaccination. The estimated geometric mean titer (GMT) ratio (vaccine/placebo) was 2.07 (95% CI: 1.48, 2.88). The geometric mean fold-rise (GMFR) from prevaccination to week 4 post-vaccination was 2.1 in zoster vaccine recipients, versus 1.0 in placebo recipients.
In HZ history-positive adults > or = 50 years of age, zoster vaccine: (1) was well tolerated; and (2) significantly boosted the level of VZV antibody from baseline to 4 weeks post-vaccination as measured by GMT and GMFR. These data support the Advisory Committee on Immunization Practices' recommendation for routine zoster vaccination for all immunocompetent persons >/=60 years of age irrespective of HZ history.
- SourceAvailable from: Joshua Michel
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- "They range from the chronically ill residents of nursing home/assisted-living institutions, to the communitydwellers who are highly functional despite history of chronic diseases and/or concurrent clinical conditions  . Many older adults retain the capacity to mount vigorous immune responses as exemplified by their protection from the 2009 pandemic H1N1 influenza [18- 20], and by the indicated efficacy of the varicella zoster vaccine  . There is also mounting evidence that age may no longer be considered a barrier for organ transplantation from the perspective of either the recipient or the donor   . "
ABSTRACT: Studies comparing chronologically "young" versus "old" humans document age-related decline of classical immunological functions. However, older adults aged ≥65 years have very heterogeneous health phenotypes. A significant number of them are functionally independent and are surviving well into their 8(th)-11(th) decade life, observations indicating that aging or old age is not synonymous with immune incompetence. While there are dramatic age-related changes in the immune system, not all of these changes may be considered detrimental. Here, we review evidences for novel immunologic processes that become elaborated with advancing age that complement preserved classical immune functions and promote immune homeostasis later in life. We propose that elaboration such of late life immunologic properties is indicative of beneficial immune remodeling that is an integral component of successful aging, an emerging physiologic construct associated with similar age-related physiologic adaptations underlying maintenance of physical and cognitive function. We suggest that a systems approach integrating immune, physical, and cognitive functions, rather than a strict immunodeficiency-minded approach, will be key towards innovations in clinical interventions to better promote protective immunity and functional independence among the elderly.02/2012; 3(1):34-50.
- Clinical and vaccine Immunology: CVI 10/2009; 16(9):1381; author reply 1381-2. DOI:10.1128/CVI.00338-08 · 2.37 Impact Factor
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ABSTRACT: There is a strong correlation between the incidence of herpes zoster (HZ) and increasing age, with a marked rise in incidence from approximately the age of 50-60 years. The lifetime risk is approximately 25% and the disease is associated with acute and sometimes persistent pain, which substantially reduces the day-to-day functioning and quality of life of affected individuals, particularly older adults. The disease most commonly occurs as a result of an age-related decline in cell-mediated immunity. A live attenuated zoster vaccine has been developed to boost the varicella-zoster virus-specific cell-mediated immunity of older adults and, via this mechanism, protect the individual against HZ and its complications. Evidence that the vaccine is effective in older patients comes from the pivotal Shingles Prevention Study. This was a randomized, double-blind, placebo-controlled trial involving approximately 40,000 adults aged 60 years or more. The HZ vaccinated group had a 51% lower incidence of HZ, a 67% reduction in postherpetic neuralgia (defined as pain rated at three or more on a scale ranging from zero [no pain] to ten [pain as bad as you can imagine], persisting or occurring 3 months or more after rash onset), and a 61% lower burden of illness (a composite measure of the incidence, severity and duration of pain and discomfort caused by HZ), indicating that the vaccine decreased both the incidence of HZ and the average severity of HZ in vaccinees who developed HZ. Moreover, there was a 73% reduction in the number of cases of HZ with severe and long-lasting pain. Overall, the vaccine was well-tolerated with the most common adverse events being mild injection site reactions and headache. A continuation trial from the Shingles Prevention Study involving over 14,000 patients approximately 7000 in the HZ vaccine and placebo groups) confirmed that the efficacy of vaccination against HZ is durable through 7 years in terms of a significantly reduced incidence of HZ, a reduced incidence of postherpetic neuralgia and a markedly lower burden of illness. Although significant improvements have been made, available treatment options are only partially effective, and once postherpetic neuralgia is established, management is difficult. Therefore, the introduction of the zoster vaccine is a promising strategy to reduce morbidity associated with HZ, a particular concern in older adults.Expert Review of Vaccines 03/2010; 9(3 Suppl):31-5. DOI:10.1586/erv.10.32 · 4.22 Impact Factor