ZOSTAVAX SUMMARY
ZOSTAVAX is a lyophilized preparation of the Oka/Merck strain of live, attenuated varicella-zoster virus (VZV). ZOSTAVAX, when reconstituted as directed, is a sterile suspension for subcutaneous administration.
ZOSTAVAX is a live attenuated virus vaccine indicated for prevention of herpes zoster (shingles) in individuals 60 years of age and older.
ZOSTAVAX is not indicated for the treatment of zoster or postherpetic neuralgia (PHN).
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NEWS HIGHLIGHTS
Published Studies Related to Zostavax (Zoster Vaccine Live)
Herpes zoster pathogenesis and cell-mediated immunity and immunosenescence. [2009.06]
Herpes zoster, or shingles, is a localized disease characterized by unilateral radicular pain and a vesicular rash limited to the area of skin innervated by a single dorsal root or cranial sensory ganglion. Whereas varicella, or chickenpox, results from primary exogenous varicella-zoster virus (VZV) infection, herpes zoster is caused by reactivation of endogenous VZV that has persisted in latent form within sensory ganglia following an earlier episode of chickenpox...
Comparison of the levels of immunogenicity and safety of Zostavax in adults 50 to 59 years old and in adults 60 years old or older. [2009.05]
Zostavax has been shown to be efficacious in the prevention of herpes zoster and generally well tolerated in clinical trials among subjects 60 years old or older. This prespecified combined analysis from two studies compares the levels of immunogenicity and safety of Zostavax in subjects 50 to 59 years old versus those in subjects >or=60 years old...
A novel vaccine (Zostavax) to prevent herpes zoster. [2008.04]
Varicella-zoster virus is the causal agent of varicella and herpes zoster (HZ) in humans. HZ results from reactivation of latent varicella-zoster virus (VZV) within the sensory ganglia.In this review, the authors will discuss the history of the use of the varicella vaccine in children, and the subsequent development of the new HZ vaccine.
Varicella-zoster virus-specific immune responses in elderly recipients of a herpes zoster vaccine. [2008.03.15]
BACKGROUND: A double-blind, placebo-controlled trial that involved 38,546 subjects > or =60 years old demonstrated efficacy of a high-potency live-attenuated Oka/Merck varicella-zoster virus (VZV) vaccine. The trial included an immunology substudy to determine the relationship of VZV-specific immune responses to vaccination and clinical outcome... CONCLUSIONS: The zoster vaccine induced a significant increase in VZV-CMI and VZV antibody. The magnitude and duration of the boost in VZV-CMI in vaccine recipients and the relationship of this boost to age paralleled the clinical effects of the vaccine observed during the efficacy trial. These findings support the hypothesis that boosting VZV-CMI protects older adults against herpes zoster and postherpetic neuralgia.
Vaccination against Herpes Zoster and Postherpetic Neuralgia. [2008.03.01]
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... CONCLUSION: The Shingles Prevention Study demonstrated that HZ vaccine significantly reduced the morbidity due to HZ and PHN in older adults.
Clinical Trials Related to Zostavax (Zoster Vaccine Live)
Live Zoster Vaccine in HIV-Infected Adults on Antiretroviral Therapy [Recruiting]
Herpes zoster, or shingles, is the result of a viral infection that causes a painful skin
rash, usually in older people or people with suppressed immune systems like those infected
with HIV. The ZOSTAVAX vaccine has been shown to reduce the number of infections and
symptoms of herpes zoster infection in people over the age of 60. The purpose of this study
is to test the safety and tolerability of ZOSTAVAX in HIV-infected adults.
A Study to Evaluate Immunity to Varicella Zoster Virus After Immunization With V212 Vaccine or Zostavax [Recruiting]
A study in two parts to evaluate the responsiveness of various biomarkers of immunity to
Varicella-Zoster Virus following repeated immunizations with heat treated VZV vaccine V212
or with Zostavax.
Safety and Immunogenicity of Zostavax Vaccine in Patients Undergoing Living Donor Kidney Transplantation [Not yet recruiting]
Varicella zoster virus is part of the herpesvirus group and causes chickenpox in exposed
individuals. The majority of the population is seropositive for this virus. Reactivation of
varicella zoster virus occurs in up to 30% of the general population over 60 years old.
Solid organ transplant recipients receive lifelong immunosuppression drugs and are at great
risk of reactivation of all herpesviruses including the varicella zoster virus regardless of
age. The vaccine has been shown to be effective in preventing shingles in the general
population. The investigators' purpose is to determine how well the vaccine works in
patients on renal replacement therapy and post-transplant.
ZOSTAVAX™ in Patients on Chronic/Maintenance Corticosteroids [Recruiting]
The purpose of the study is to determine whether ZOSTAVAX™ is safe, generally well
tolerated, and immunogenic in patients on chronic/maintenance corticosteroids.
Safety & Immunogenicity of GlaxoSmithKline Biologicals' Herpes Zoster Vaccine 1437173A [Recruiting]
The purpose of this observer-blind study is to evaluate the safety and immunogenicity of
GlaxoSmithKline Biologicals' investigational Herpes Zoster vaccine GSK1437173A when
administered as 2 doses or 3 doses to hematopoietic stem cell transplant (HCT) recipients.
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