Zoster Vaccine Response in the Frail Elderly

McMaster University

Status: Completed

Conditions: Immune System Diseases

Treatments: Drug: Zostavax

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01328548

09-450

Details and patient eligibility

About

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.

Full 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.

Enrollment: 241 patients

Sex: All

Ages: 80+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

241 participants in 3 patient groups

Nursing Home Elderly Cases

Description:

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.

Treatment:

Drug: Zostavax

Nursing Home Elderly Controls

Description:

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.

Treatment:

Drug: Zostavax

Community dwelling seniors

Description:

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.

Treatment:

Drug: Zostavax