Overview

This trial is active, not recruiting.

Condition immune system diseases
Sponsor McMaster University
Collaborator Merck Sharp & Dohme Corp.
Start date May 2011
End date December 2015
Trial size 250 participants
Trial identifier NCT01328548, 09-450

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
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 case will be considered failure to mount a high response.
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.
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.

Primary Outcomes

Measure
Change from Baseline in T-cell response to the VZV vaccine in the frail elderly
time frame: 6 weeks
Assessment of immune parameters compatible with inflammaging: CD4+/CD8+ ratio
time frame: Baseline
Assessment of immune parameters compatible with inflammaging: high CD8+CD28-CD45RA+ T cells
time frame: Baseline
Assessment of immune parameters compatible with inflammaging: TEMRA Cells
time frame: Baseline
Assessment of immune parameters compatible with inflammaging: high T regulatory cells
time frame: Baseline
Testing 150 candidate immune response genes for SNP analysis
time frame: Baseline

Eligibility Criteria

Male or female participants at least 80 years old.

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

Additional Information

Official title Immune and Genetic Correlates of Response to Zoster Vaccine in the Frail Elderly: a Pilot Study
Principal investigator Mark B. Loeb, FRCPC,MD,MSc
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by McMaster University.