Clinical trial NCT01328548: Zoster Vaccine Response in the Frail Elderly
Official title: Immune and Genetic Correlates of Response to Zoster Vaccine in the Frail Elderly: a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Immune System Diseases
Keywords: varicella-zoster virus
vaccine
T-cell
genes
frail elderly
immunosenescence
immune and genetic correlates of response to zoster vaccine in the elderly
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2011-04-04
Enrollment: 241
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly, non-ambulatory residents of nursing homes.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in T-cell Response to the VZV Vaccine in the Frail Elderly
timeFrame: 6 weeks
measure: Assessment of Immune Parameters Compatible With Inflammaging: CD4+/CD8+ Ratio
timeFrame: Baseline
measure: Assessment of Immune Parameters Compatible With Inflammaging: High T Regulatory Cells
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
measure: Assessment of Immune Parameters Compatible With Inflammaging: TEMRA Cells
timeFrame: Baseline
measure: Assessment of Immune Parameters Compatible With Inflammaging: High CD8+CD28CD45RA+T Cells
timeFrame: Baseline
measure: Testing 150 Candidate Immune Response Genes for SNP Analysis
timeFrame: Baseline
measure: Assessment of Immune Parameters Compatible With Inflammaging: CD4 Cell Frequency
timeFrame: Baseline
Locations:
city: Hamilton
country: Canada
facility: Macassa Lodge
state: Ontario
Study officials:
affiliation: McMaster University
name: Mark B. Loeb, FRCPC,MD,MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lelic A, Verschoor CP, Lau VW, Parsons R, Evelegh C, Bowdish DM, Bramson JL, Loeb MB. Immunogenicity of Varicella Vaccine and Immunologic Predictors of Response in a Cohort of Elderly Nursing Home Residents. J Infect Dis. 2016 Dec 15;214(12):1905-1910. doi: 10.1093/infdis/jiw462. Epub 2016 Oct 5.