NCT01262300

Vitamin D Supplementation And Varicella Zoster Virus Vaccine Responsiveness In Older Long-Term Care Residents

Vitamin D Supplementation And Varicella Zoster Virus Vaccine Responsiveness In Older Nursing Home Residents

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Objectives 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. 2. 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. 3. 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. Hypotheses 1. At baseline, higher serum 25(OH)D levels will be associated with higher levels of VZV-specific cell-mediated immunity (cross-sectional). 2. 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. 3. 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.

Conditions

• Immunosenescence
• Shingles

Interventions

Type	Name	Description
BIOLOGICAL	Varicella Zoster Virus Vaccine (Zostavax)	Single 0.65 mL subcutaneous injection of the live, attenuated VZV zoster vaccine (Zostavax; Merck, Whitehouse Station, NJ).

Timeline

• Start date: 2010-11-01
• Primary completion: 2014-01-23
• Completion: 2014-01-23
• First posted: 2010-12-17
• Last updated: 2021-06-25

Locations

1 site across 1 country: United States