NCT01328548

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
241

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2011

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 4, 2011

Completed
27 days until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

April 14, 2017

Completed
Last Updated

October 29, 2018

Status Verified

October 1, 2018

Enrollment Period

3.8 years

First QC Date

March 15, 2011

Results QC Date

March 3, 2016

Last Update Submit

October 25, 2018

Conditions

Immune System Diseases

Keywords

varicella-zoster virusvaccineT-cellgenesfrail elderlyimmunosenescenceimmune and genetic correlates of response to zoster vaccine in the elderly

Outcome Measures

Primary Outcomes (3)

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

    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.

    6 weeks

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

    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.

    Baseline

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

    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.

    Baseline

Other Outcomes (4)

  • Assessment of Immune Parameters Compatible With Inflammaging: TEMRA Cells

    Baseline

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

    Baseline

  • Testing 150 Candidate Immune Response Genes for SNP Analysis

    Baseline

  • +1 more other outcomes

Study Arms (3)

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

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

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

Interventions

ZostavaxDRUG
Also known as: Zoster vaccine
Community dwelling seniorsNursing Home Elderly CasesNursing Home Elderly Controls

Eligibility Criteria

Age80 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elderly, non-ambulatory residents of nursing homes.

You may qualify if:

  • nursing home resident
  • greater than or equal to 80 years old
  • non-ambulatory

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Macassa Lodge

Hamilton, Ontario, Canada

Location

Related Publications (1)

  • 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.

    PMID: 27707807DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Retained specimens include DNA and blood cells.

MeSH Terms

Conditions

Immune System DiseasesChickenpox

Interventions

Herpes Zoster Vaccine

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Chickenpox VaccineHerpesvirus VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Results Point of Contact

Title
Dr. Mark Loeb
Organization
McMaster University
loebm@mcmaster.ca
905 515 9140

Study Officials

  • Mark B. Loeb, FRCPC,MD,MSc

    McMaster University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2011

First Posted

April 4, 2011

Study Start

May 1, 2011

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

October 29, 2018

Results First Posted

April 14, 2017

Record last verified: 2018-10

Locations

CA(1)