Zoster Vaccine Response in the Frail Elderly

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

241 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2015-03-31

Brief Summary

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This study is being done to evaluate the zoster vaccine response in the nursing home elderly (80 years or older). As the immune system ages, the response to vaccines is not always as strong as in younger people. Previous zoster vaccine studies have excluded nursing home residents so the vaccine effect in this population is not known. Furthermore, the immune and genetic reasons as to why the vaccine works well in some people but not in others are also unknown. The goal of this study is to evaluate why some immune systems respond well to the vaccine and why others do not.

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Detailed Description

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Deleterious changes in immunity that occur with aging are known as immunosenescence. Such changes, particularly in adaptive immunity, may lead to an impaired vaccine response in the elderly. Characterizing the immune determinants and the genetic basis for vaccine response in the frail elderly is a practical approach to better our understanding of immunosenescence. Data on genetic determinants to immunization are sparse, furthermore, to the best of our knowledge, none exist in the elderly. In this pilot study, we propose studying the immune response to the herpes zoster vaccine and the underlying genetic determinants of the immune response in elderly residents of nursing homes.

The three specific aims of this study are to generate data in order to 1) assess the T-cell response to the varicella-zoster virus (VZV) vaccine in the frail elderly; 2) assess whether immune (T-cell) phenotypes are associated with a response; 3) test the association between immune response genotype sets and T-cell response. We hypothesize that response to the VZV vaccine in elderly nonambulatory nursing home residents is a function of characteristic T-cell immune phenotypes prior to vaccination and that there are immune genetic polymorphisms associated with the response. This study will allow us to generate preliminary data and establish feasibility in order to address these questions fully in a larger population in a subsequent grant application.

Conditions

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Immune System Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Nursing Home Elderly Cases

Non-ambulatory nursing home residents \>= 80 years old will be vaccinated with the zoster vaccine and provide baseline and post-vaccination blood samples. We will assess differences in genotype frequencies between participants with high and low RCF and ELISPOT responses using a candidate gene approach with SNPs (single nucleotide polymorphisms). A case will be considered failure to mount a high response.

Zostavax

Intervention Type DRUG

Nursing Home Elderly Controls

Non-ambulatory nursing home residents \>= 80 years old will be vaccinated with the zoster vaccine and provide baseline and post-vaccination blood samples. We will assess differences in genotype frequencies between participants with high and low RCF and ELISPOT responses using a candidate gene approach with SNPs. A control will be a participant who mounted an adequate response as defined in primary outcomes.

Zostavax

Intervention Type DRUG

Community dwelling seniors

Community dwelling seniors ages 60-75 will be enrolled as a control group for the laboratory testing. They will be vaccinated and will provide pre- and post-vaccination blood. If nursing home residents do not show a response it is important to know that it is not a failure of the laboratory's measurement of immunogenicity.

Zostavax

Intervention Type DRUG

Interventions

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Zostavax

Intervention Type DRUG

Other Intervention Names

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Zoster vaccine

Eligibility Criteria

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Inclusion Criteria

* nursing home resident
* greater than or equal to 80 years old
* non-ambulatory

Exclusion Criteria

* less than 80 years old
* ambulatory
* taking immunosuppressive medication
* history of primary or acquired immuno-deficiency states including leukemia, other malignant neoplasms affecting the bone marrow or lymphatic system, and AIDS
* active untreated tuberculosis
* previous receipt of varicella vaccine
* residents expected to expire within 30 days, in the opinion of the most responsible physician
* residents planning to move nursing homes within the year
* temporary residents

Minimum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes