Vitamin D Supplementation And Varicella Zoster Virus Vaccine Responsiveness In Older Long-Term Care Residents
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|ClinicalTrials.gov Identifier: NCT01262300|
Recruitment Status : Active, not recruiting
First Posted : December 17, 2010
Last Update Posted : June 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Immunosenescence Shingles||Biological: Varicella Zoster Virus Vaccine (Zostavax)||Phase 1|
- To determine the increase in Varicella-zoster virus (VZV)-specific cell-mediated immune response from pre-zoster vaccination to 3 weeks post-vaccination in nursing home residents after 4 months of high dose vs. standard dose vitamin D3 supplementation.
- In the same participants as Aim 1, to measure the association between pre-zoster vaccination 25-hydroxyvitamin D [25(OH)D] levels and the increase in VZV-specific cell-mediated immune response from pre- vaccination to 3 weeks post-vaccination.
- Characterize the phenotypic and functional VZV-specific T cell responses to Zostavax, including memory, effector, Th1/Th2, and homing receptor-bearing T cells in the high compared to low ELISPOT responders.
- At baseline, higher serum 25(OH)D levels will be associated with higher levels of VZV-specific cell-mediated immunity (cross-sectional).
- At baseline, higher serum 25(OH)D levels, independent of vitamin D supplementation dose, will be associated with greater increases in VZV-specific cell-mediated immune responses to Zostavax, as measured by the interferon (IFN)-γ ELISPOT assay.
- Compared to standard dose, high dose vitamin D3 supplementation will enhance VZV-specific cell-mediated immune response to vaccination independent of baseline serum 25(OH)D levels.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Vitamin D Supplementation And Varicella Zoster Virus Vaccine Responsiveness In Older Nursing Home Residents|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||November 2014|
|Estimated Study Completion Date :||December 2020|
Experimental: VZV vaccine
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.
Biological: Varicella Zoster Virus Vaccine (Zostavax)
Single 0.65 mL subcutaneous injection of the live, attenuated VZV zoster vaccine (Zostavax; Merck, Whitehouse Station, NJ).
- VZV-specific cell mediated immunity, as measured by the interferon-γ ELISPOT assay [ Time Frame: 3 weeks post-vaccination ]
- VZV-gpELISA to measure the VZV-specific antibody concentration [ Time Frame: 3 weeks post-vaccination ]
- VZV-specific effector and memory T cells [ Time Frame: 3 weeks post-vaccination ]
- -specific cell mediated immunity, as measured by the responder cell frequency assay [ Time Frame: 3 weeks post-vaccination ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01262300
|United States, Colorado|
|University of Colorado Denver|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Adit A Ginde, MD, MPH||University of Colorado, Denver|