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Zoster Vaccine Response in the Frail Elderly

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ClinicalTrials.gov Identifier: NCT01328548
Recruitment Status : Completed
First Posted : April 4, 2011
Results First Posted : April 14, 2017
Last Update Posted : October 29, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
McMaster University

Study Description
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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.

Condition or disease Intervention/treatment
Immune System Diseases Drug: Zostavax

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.

Study Design
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Study Type : Observational
Actual Enrollment : 241 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Immune and Genetic Correlates of Response to Zoster Vaccine in the Frail Elderly: a Pilot Study
Study Start Date : May 2011
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Shingles

Groups and Cohorts
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Group/Cohort Intervention/treatment
Nursing Home Elderly Cases
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.
 Drug: Zostavax
Other Name: Zoster vaccine
Nursing Home Elderly Controls
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.
 Drug: Zostavax
Other Name: Zoster vaccine
Community dwelling seniors
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.
 Drug: Zostavax
Other Name: Zoster vaccine


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures:
  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.


Biospecimen Retention:   Samples With DNA
Retained specimens include DNA and blood cells.

Eligibility Criteria
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Ages Eligible for Study:   80 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Elderly, non-ambulatory residents of nursing homes.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01328548


Locations
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Canada, Ontario
Macassa Lodge
Hamilton, Ontario, Canada
Sponsors and Collaborators
McMaster University
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Mark B. Loeb, FRCPC,MD,MSc McMaster University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT01328548    
Other Study ID Numbers: 09-450
First Posted: April 4, 2011    Key Record Dates
Results First Posted: April 14, 2017
Last Update Posted: October 29, 2018
Last Verified: October 2018
Keywords provided by McMaster University:
varicella-zoster virus
vaccine
T-cell
genes
 frail elderly
immunosenescence
immune and genetic correlates of response to zoster vaccine in the elderly
Additional relevant MeSH terms:
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Immune System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs