Zoster Vaccine Response in the Frail Elderly
25 oktober 2018 uppdaterad 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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
241
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Ontario
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Hamilton, Ontario, Kanada
- Macassa Lodge
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
80 år och äldre (Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Elderly, non-ambulatory residents of nursing homes.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / 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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Andra namn:
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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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Andra namn:
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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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Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Change From Baseline in T-cell Response to the VZV Vaccine in the Frail Elderly
Tidsram: 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
Tidsram: 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
Tidsram: 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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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Assessment of Immune Parameters Compatible With Inflammaging: TEMRA Cells
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Mark B. Loeb, FRCPC,MD,MSc, McMaster University
Publikationer och användbara länkar
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 maj 2011
Primärt slutförande (Faktisk)
1 mars 2015
Avslutad studie (Faktisk)
1 mars 2015
Studieregistreringsdatum
Först inskickad
15 mars 2011
Först inskickad som uppfyllde QC-kriterierna
1 april 2011
Första postat (Uppskatta)
4 april 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
29 oktober 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
25 oktober 2018
Senast verifierad
1 oktober 2018
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 09-450
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