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NCT Number: NCT01328548

Zoster Vaccine Response in the Frail Elderly

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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Key information

Conditions

Immune System Diseases Chickenpox DNA Virus Infections Herpesviridae Infections Infections Varicella Zoster Virus Infection Virus Diseases

Age range

80 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Macassa Lodge

Hamilton, Ontario, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zostavax

Drug

Other names: Zoster vaccine

Primary outcomes

  1. Change From Baseline in T-cell Response to the VZV Vaccine in the Frail Elderly

    Time frame: 6 weeks

    As the primary phenotype, we will compare change in Enzyme-linked immunosorbent spot (ELISPOT) from baseline (i.e., pre and post vaccination). A high baseline T cell response will be defined as ELISPOT = >50 spots and a low baseline response will be ELISPOT = <10 spots.

  2. Assessment of Immune Parameters Compatible With Inflammaging: CD4+/CD8+ Ratio

    Time frame: Baseline

    Characterization of T-cell populations will be conducted on whole blood using multi-parametric flow cytometry prior to immunization to characterize the immunological function of circulating T-cells in the nursing home vaccine group.

  3. Assessment of Immune Parameters Compatible With Inflammaging: High T Regulatory Cells

    Time frame: Baseline

    Characterization of T-cell populations will be conducted on whole blood using multi-parametric flow cytometry prior to immunization to characterize the immunological function of circulating T-cells in the nursing home vaccine group.

Other outcomes

  1. Assessment of Immune Parameters Compatible With Inflammaging: TEMRA Cells

    Time frame: Baseline

    Characterization of Tcell populations will be conducted on whole blood using multiparametric flow cytometry prior to immunization to characterize the immunological function of circulating Tcells in each participant.

  2. Assessment of Immune Parameters Compatible With Inflammaging: High CD8+CD28CD45RA+T Cells

    Time frame: Baseline

    Characterization of Tcell populations will be conducted on whole blood using multiparametric flow cytometry prior to immunization to characterize the immunological function of circulating Tcells in each participant.

  3. Testing 150 Candidate Immune Response Genes for SNP Analysis

    Time frame: Baseline

    These will include Tolllike receptors, cytokines, chemokines, chemokine receptors, interferons and interferon receptors. Tolllike receptors: TLR1TLR9 Cytokines: ILI1A, ILI1B, IL1RN, IL4, IL5, IL12B, IL13, CSF2 Chemokines: CCL1CCL3, CCL3L1, CCL4CCL8, CCL11, CCL13, CCL15CCL28, CXCL1CXCL14, CXCL16, CX3CL1 Chemokine receptors: CCR1CCR10, CXCR1CXCR6, CX3CR1, XCR1XCR2 Interferons: IFNA1IFNA2, IFNA4IFNA8, IFNA10, IFNA13, IFNA14, IFNA16IFNA17, IFNA21, IFNB1, IFNB3, IFNG, IFNK, IFNW1 Interferon receptors: IFNAR1, IFNAR2, IFNGR1, IFNGR2

  4. Assessment of Immune Parameters Compatible With Inflammaging: CD4 Cell Frequency

    Time frame: Baseline

    Characterization of T-cell populations will be conducted on whole blood using multi-parametric flow cytometry prior to immunization to characterize the immunological function of circulating T-cells in the nursing home vaccine group.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Apr 4, 2011
Registry last updated
Oct 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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