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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01262300
Recruitment Status : Active, not recruiting
First Posted : December 17, 2010
Last Update Posted : December 1, 2017
Information provided by (Responsible Party):

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:


  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.


  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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
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 : November 2010
Primary Completion Date : November 2014
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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).

Outcome Measures

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

Secondary Outcome Measures :
  1. VZV-gpELISA to measure the VZV-specific antibody concentration [ Time Frame: 3 weeks post-vaccination ]
  2. VZV-specific effector and memory T cells [ Time Frame: 3 weeks post-vaccination ]
  3. -specific cell mediated immunity, as measured by the responder cell frequency assay [ Time Frame: 3 weeks post-vaccination ]

Eligibility Criteria

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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.
Contacts and Locations

Information from the National Library of Medicine

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
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

A randomized controlled trial of high dose vitamin D in older long-term care residents (NCT01102374)

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01262300     History of Changes
Other Study ID Numbers: 10-0189
K23AG040708 ( U.S. NIH Grant/Contract )
First Posted: December 17, 2010    Key Record Dates
Last Update Posted: December 1, 2017
Last Verified: November 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