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| ID | Type | Description | Link |
|---|---|---|---|
| K23AG040708 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| Merck Sharp & Dohme LLC | INDUSTRY |
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This is an ancillary study to a randomized controlled trial of high dose vitamin D in older long-term care residents (NCT01102374). In this study, a subset of trial subjects will receive the zoster vaccine and the investigators will determine the immunological response to the vaccine in this older, frail population, as well as the association between vitamin D and immunological outcomes.
Objectives
Hypotheses
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VZV vaccine | Experimental | Varicella Zoster Virus vaccine (Zostavax), single dose X 1 injection All subjects in this trial will receive the VZV vaccine. The Investigators will primarily compare immune responses in those that are receiving high dose vs. standard dose vitamin D supplementation and those that have high and low 25-hydroxyvitamin D levels. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varicella Zoster Virus Vaccine (Zostavax) | Biological | Single 0.65 mL subcutaneous injection of the live, attenuated VZV zoster vaccine (Zostavax; Merck, Whitehouse Station, NJ). |
| Measure | Description | Time Frame |
|---|---|---|
| VZV-specific cell mediated immunity, as measured by the interferon-γ ELISPOT assay | 3 weeks post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| VZV-gpELISA to measure the VZV-specific antibody concentration | 3 weeks post-vaccination | |
| VZV-specific effector and memory T cells | 3 weeks post-vaccination | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adit A Ginde, MD, MPH | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | A randomized controlled trial of high dose vitamin D in older long-term care residents (NCT01102374) |
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| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| D002644 | Chickenpox |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D053061 | Herpes Zoster Vaccine |
| ID | Term |
|---|---|
| D019433 | Chickenpox Vaccine |
| D022283 | Herpesvirus Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
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| -specific cell mediated immunity, as measured by the responder cell frequency assay |
| 3 weeks post-vaccination |
| D007239 | Infections |
| D001688 |
| Biological Products |
| D045424 | Complex Mixtures |