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NCT Number: NCT01262300

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

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Colorado Denver

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Varicella Zoster Virus Vaccine (Zostavax)

Biological

Single 0.65 mL subcutaneous injection of the live, attenuated VZV zoster vaccine (Zostavax; Merck, Whitehouse Station, NJ).

Primary outcomes

  1. VZV-specific cell mediated immunity, as measured by the interferon-γ ELISPOT assay

    Time frame: 3 weeks post-vaccination

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Merck Sharp & Dohme LLC
  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Dec 17, 2010
Registry last updated
Jun 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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