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

Sponsor

University of Colorado, Denver (Other)

Overall Status

Completed

CT.gov ID

NCT01262300

Collaborator

National Institute on Aging (NIA) (NIH), Merck Sharp & Dohme LLC (Industry)

Enrollment

Location

Arm

38.7

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Immunosenescence Shingles	Biological: Varicella Zoster Virus Vaccine (Zostavax)	Phase 1

Detailed Description

Objectives

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.

Hypotheses

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 Design

Study Type:

Interventional

Actual Enrollment :

33 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Nov 1, 2010

Actual Primary Completion Date :

Jan 23, 2014

Actual Study Completion Date :

Jan 23, 2014

Arms and Interventions

Arm	Intervention/Treatment
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).

Arm

Intervention/Treatment

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).

Outcome Measures

Primary Outcome Measures

VZV-specific cell mediated immunity, as measured by the interferon-γ ELISPOT assay [3 weeks post-vaccination]

Secondary Outcome Measures

VZV-gpELISA to measure the VZV-specific antibody concentration [3 weeks post-vaccination]
VZV-specific effector and memory T cells [3 weeks post-vaccination]
-specific cell mediated immunity, as measured by the responder cell frequency assay [3 weeks post-vaccination]

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Aged ≥ 60 years;
Residing in a long-term care facility;
Have not yet received VZV vaccine

Exclusion Criteria:

terminal illness (expected survival <6 months);
anticipated discharge within 12 months;
unable to take whole or crushed tablets;
active cancer, except squamous/basal cell carcinoma;
severe malnutrition (body mass index <18 kg/m2);
current immunosuppressive medications (including corticosteroids);
renal failure (eGFR<15 mL/min/1.73m2);
currently taking >800 IU/d vitamin D supplementation;
history (or strong family history) of kidney stones;
history of sarcoidosis or other granulomatous disorders associated with hypercalcemia;
elevated baseline hypercalcemia (albumin-adjusted serum calcium >10.5 mg/dL);
serum 25 (OH)D level ≥40 ngl/ml at baseline;
inability to provide informed consent and no available healthcare proxy;
inability of participant or proxy to speak/understand English.
previous receipt of the Zostavax (anticipate <10% of trial;
known allergy to gelatin, neomycin, or any other component of the vaccine.