Zoster Vaccine Response in the Frail Elderly
25. oktober 2018 oppdatert av: McMaster University
Immune and Genetic Correlates of Response to Zoster Vaccine in the Frail Elderly: a Pilot Study
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.
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Faktiske)
241
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Ontario
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Hamilton, Ontario, Canada
- Macassa Lodge
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
80 år og eldre (Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Elderly, non-ambulatory residents of nursing homes.
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
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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.
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Andre navn:
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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.
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Andre navn:
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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.
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Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Change From Baseline in T-cell Response to the VZV Vaccine in the Frail Elderly
Tidsramme: 6 weeks
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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.
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6 weeks
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Assessment of Immune Parameters Compatible With Inflammaging: CD4+/CD8+ Ratio
Tidsramme: Baseline
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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.
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Baseline
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Assessment of Immune Parameters Compatible With Inflammaging: High T Regulatory Cells
Tidsramme: Baseline
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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.
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Baseline
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Assessment of Immune Parameters Compatible With Inflammaging: TEMRA Cells
Tidsramme: Baseline
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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.
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Baseline
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Assessment of Immune Parameters Compatible With Inflammaging: High CD8+CD28CD45RA+T Cells
Tidsramme: Baseline
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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.
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Baseline
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Testing 150 Candidate Immune Response Genes for SNP Analysis
Tidsramme: Baseline
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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
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Baseline
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Assessment of Immune Parameters Compatible With Inflammaging: CD4 Cell Frequency
Tidsramme: Baseline
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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.
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Baseline
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Samarbeidspartnere og etterforskere
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Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Mark B. Loeb, FRCPC,MD,MSc, McMaster University
Publikasjoner og nyttige lenker
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mai 2011
Primær fullføring (Faktiske)
1. mars 2015
Studiet fullført (Faktiske)
1. mars 2015
Datoer for studieregistrering
Først innsendt
15. mars 2011
Først innsendt som oppfylte QC-kriteriene
1. april 2011
Først lagt ut (Anslag)
4. april 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
29. oktober 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. oktober 2018
Sist bekreftet
1. oktober 2018
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 09-450
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