Clinical Trials Directory

Trials / Completed

CompletedNCT01328548

Zoster Vaccine Response in the Frail Elderly

Immune and Genetic Correlates of Response to Zoster Vaccine in the Frail Elderly: a Pilot Study

Status
Completed
Phase
Study type
Observational
Enrollment
241 (actual)
Sponsor
McMaster University · Academic / Other
Sex
All
Age
80 Years
Healthy volunteers
Accepted

Summary

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.

Detailed description

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

Interventions

TypeNameDescription
DRUGZostavax

Timeline

Start date
2011-05-01
Primary completion
2015-03-01
Completion
2015-03-01
First posted
2011-04-04
Last updated
2018-10-29
Results posted
2017-04-14

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT01328548. Inclusion in this directory is not an endorsement.