Zoster Vaccine Response in the Frail Elderly

Immune System Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01328548
• Other study ID #: 09-450
• Status: Completed
• Start date: May 2011
• Est. completion date: March 2015

Study information

• Verified date: October 2018
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 80 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Immune System Diseases

Intervention

Drug:
• Zostavax

Locations

Country	Name	City	State
Canada	Macassa Lodge	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessment of Immune Parameters Compatible With Inflammaging: TEMRA Cells	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.	Baseline
Other	Assessment of Immune Parameters Compatible With Inflammaging: High CD8+CD28CD45RA+T Cells	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.	Baseline
Other	Testing 150 Candidate Immune Response Genes for SNP Analysis	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	Baseline
Other	Assessment of Immune Parameters Compatible With Inflammaging: CD4 Cell Frequency	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
Primary	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
Primary	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
Primary	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