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- Ensaio Clínico NCT01328548
Zoster Vaccine Response in the Frail Elderly
Immune and Genetic Correlates of Response to Zoster Vaccine in the Frail Elderly: a Pilot Study
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Ontario
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Hamilton, Ontario, Canadá
- Macassa Lodge
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
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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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Outros nomes:
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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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Outros nomes:
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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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Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Change From Baseline in T-cell Response to the VZV Vaccine in the Frail Elderly
Prazo: 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
Prazo: 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
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Assessment of Immune Parameters Compatible With Inflammaging: TEMRA Cells
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Mark B. Loeb, FRCPC,MD,MSc, McMaster University
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 09-450
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