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Trial record 17 of 390 for:    Shingles

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

This study is ongoing, but not recruiting participants.
National Institute on Aging (NIA)
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of Colorado, Denver Identifier:
First received: December 15, 2010
Last updated: January 20, 2017
Last verified: January 2017
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 we 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 Intervention Phase
Biological: Varicella Zoster Virus Vaccine (Zostavax)
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Prevention
Official Title: Vitamin D Supplementation And Varicella Zoster Virus Vaccine Responsiveness In Older Nursing Home Residents

Resource links provided by NLM:

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • VZV-specific cell mediated immunity, as measured by the interferon-γ ELISPOT assay [ Time Frame: 3 weeks post-vaccination ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 33
Study Start Date: November 2010
Estimated Study Completion Date: June 2017
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VZV vaccine

Varicella Zoster Virus vaccine (Zostavax), single dose X 1 injection

All subjects in this trial will receive the VZV vaccine. We 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).

Detailed Description:


  1. To determine the increase in 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.


  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.

Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

1) Aged ≥ 60 years; 2) Residing in a long-term care facility; 3) Have not yet received VZV vaccine

Exclusion Criteria:

1) terminal illness (expected survival <6 months); 2) anticipated discharge within 12 months; 3) unable to take whole or crushed tablets; 4) active cancer, except squamous/basal cell carcinoma; 5) severe malnutrition (body mass index <18 kg/m2); 6) current immunosuppressive medications (including corticosteroids); 7) renal failure (eGFR<15 mL/min/1.73m2); 8) currently taking >800 IU/d vitamin D supplementation; 9) history (or strong family history) of kidney stones; 10) history of sarcoidosis or other granulomatous disorders associated with hypercalcemia; 11) elevated baseline hypercalcemia (albumin-adjusted serum calcium >10.5 mg/dL); 12) serum 25 (OH)D level ≥40 ngl/ml at baseline; 13) inability to provide informed consent and no available healthcare proxy; 14) inability of participant or proxy to speak/understand English. 15) previous receipt of the Zostavax (anticipate <10% of trial; 16) known allergy to gelatin, neomycin, or any other component of the vaccine.

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Please refer to this study by its identifier: NCT01262300

United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
National Institute on Aging (NIA)
Merck Sharp & Dohme Corp.
Principal Investigator: Adit A Ginde, MD, MPH University of Colorado, Denver
  More Information

Responsible Party: University of Colorado, Denver Identifier: NCT01262300     History of Changes
Other Study ID Numbers: 10-0189
Study First Received: December 15, 2010
Last Updated: January 20, 2017

Keywords provided by University of Colorado, Denver:
Vitamin D
Varicella Zoster Virus
Immune Response

Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Vitamin D
Immunologic Factors
Physiological Effects of Drugs
Growth Substances
Bone Density Conservation Agents processed this record on May 25, 2017