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Zostavax (Zoster Vaccine Live) - Summary

 
 



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).


See all Zostavax indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Zostavax (Zoster Vaccine Live)

Varicella-zoster virus-specific antibody responses in 50-59-year-old recipients of zoster vaccine. [2013]
Prevaccination and 6-week postvaccination samples from the immunogenicity substudy (n = 2269) of the zoster vaccine (ZV) efficacy trial (N = 22 439) in 50-59-year-old subjects were examined for varicella-zoster virus-specific antibody responses to vaccination...

Major depressive disorder and immunity to varicella-zoster virus in the elderly. [2011.05]
Major depressive disorder has been associated with activation of inflammatory processes as well as with reductions in innate, adaptive and non-specific immune responses. The objective of this study was to evaluate the association between major depression and a disease-relevant immunologic response, namely varicella-zoster virus (VZV)-specific immunity, in elderly adults...

Concomitant administration of zoster and pneumococcal vaccines in adults >/=60 years old. [2010.11]
This study evaluated safety & immunogenicity of ZOSTAVAX(R) (zoster vaccine: ZV) administered concomitantly versus nonconcomitantly with PNEUMOVAX(R) 23 (pneumococcal vaccine: PPV23)... When administered concomitantly, ZV & PPV23 vaccines were generally well tolerated.

Effect of a zoster vaccine on herpes zoster-related interference with functional status and health-related quality-of-life measures in older adults. [2010.09]
OBJECTIVE: To determine the efficacy of a zoster vaccine on herpes zoster (HR)-related interference with activities of daily living (ADLs) and health-related quality of life (HRQL)... CONCLUSIONS: Zoster vaccine reduced the burden of HZ-related interference with ADLs in the population of vaccinees and in vaccinees who developed HZ. Zoster vaccine reduced the effect of HZ on HRQL in the population of vaccinees but not in vaccinees who developed HZ. (c) 2010, Copyright the Authors. Journal compilation (c) 2010, The American Geriatrics Society.

Safety, tolerability, and immunogenicity of zoster vaccine in subjects with a history of herpes zoster. [2010.06.07]
BACKGROUND: 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... CONCLUSIONS: 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. Copyright 2010 Elsevier Ltd. All rights reserved.

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Clinical Trials Related to Zostavax (Zoster Vaccine Live)

Systems Biology of Zoster Vaccine (ZOSTAVAX´┐Ż) in Young and Elderly [Not yet recruiting]
Vaccination is the most effective way of preventing infectious diseases. Despite the success of vaccines in general, vaccines induce diminished antibody responses and lower protection in the elderly in particular. This could be explained by a defect in the early responses of an ageing immune system. A better understanding of the basic immunological mechanisms that mediate vaccine efficacy is incomplete. Such information is critical and could greatly decrease both the cost and the time to new vaccine development particularly for the geriatric population.

In this trial, the investigators will study the immunologic differences of the FDA approved licensed shingles vaccine between a younger and an older group. Thirty three healthy volunteers between the ages of 25-40 and forty four healthy volunteers between the ages of 60-79 will be enrolled in the study. Each participant in the study will be given one shingles shot. Blood work will be obtained one month before vaccination, on the day of vaccination, one day, three days, seven days, fourteen days, one month, three months and six months after vaccination. Throughout the duration of the study, the participants will be monitored for safety.

Zostavax in Systemic Lupus Erythematosus [Recruiting]
Individuals with systemic lupus erythematosus (SLE, lupus) appear to be at increased risk for the development of shingles, a painful reactivation of the varicella zoster virus that causes chicken pox.

The investigators propose to study the immune response to commercially available Zostavax vaccine (shingles vaccine) in adult patients with SLE who have minimal disease activity and are on mild immunosuppressant medications, and to compare the immune response to that seen in healthy people following vaccination. Acceptable immunosuppressive drugs permitted in the study are those felt to be safe according to Centers for Disease Control guidelines.

Ten healthy people and 10 SLE patients (all over 50 years of age) will be recruited to receive a single, standard dose of Zostavax. Blood samples and physical examination will be performed prior to injection, then 2,6,and 12 weeks following vaccination. All participants will receive active vaccine, there is no placebo group.

ZOSTAVAX´┐Ż in Renal Transplant Patients [Recruiting]
The purpose of this study is to test the safety of a licensed zoster vaccine, ZOSTAVAX« (Zoster Vaccine Live) in 40 subjects, age 18 years or older, with end stage renal (kidney) disease (ESRD) who are scheduled to receive a living donor kidney transplant. ZOSTAVAX« is not licensed for use in immunosuppressed persons and in the United States for individuals less than 60 years of age. Subjects will receive either ZOSTAVAX« vaccine or placebo (inactive substance) 4-12 weeks prior to their kidney transplant. Study procedures include: physical exam, blood samples and documentation of daily temperatures and/or side effects in a diary following vaccination. Participants may be involved in study related procedures for about 15 months.

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.

Immunogenicity and Safety Study of ZOSTAVAX Administered by Intramuscular or Subcutaneous Route to Subjects Aged From 50 Years Old [Recruiting]
PRIMARY OBJECTIVES

Two co-primary objectives are:

- To demonstrate that ZOSTAVAX administered by intramuscular route (IM) is non-inferior

to ZOSTAVAX administered by subcutaneous route (SC)

- To demonstrate that ZOSTAVAX administered by IM route induces an acceptable fold-rise

of varicella zoster virus (VZV) antibody titres from pre to 4-week post-vaccination

SECONDARY OBJECTIVES

Immunogenicity objectives

- To evaluate the immunogenicity as measured by VZV antibody titres at 4 weeks following

ZOSTAVAX administered by IM or SC route

- To evaluate the immune response as measured by a second assay, the VZV Interferon gamma

Enzyme-linked immunospot (ELISPOT) at 4 weeks following ZOSTAVAX administered by IM or SC route

Safety objective

- To describe the safety profile of ZOSTAVAX administered by IM or SC route

more trials >>


Page last updated: 2014-11-30

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