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

This study is currently recruiting participants.
Verified November 2012 by University of Colorado, Denver
Sponsor:
Collaborators:
Mucosal and Vaccine Research Colorado
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01262300
First received: December 15, 2010
Last updated: November 20, 2012
Last verified: November 2012
  Purpose

Objectives

  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.

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.

Condition Intervention Phase
Immunosenescence
Shingles
Biological: Varicella Zoster Virus Vaccine (Zostavax)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • VZV-gpELISA to measure the VZV-specific antibody concentration [ Time Frame: 3 weeks post-vaccination ] [ Designated as safety issue: No ]
  • VZV-specific effector and memory T cells [ Time Frame: 3 weeks post-vaccination ] [ Designated as safety issue: No ]
  • -specific cell mediated immunity, as measured by the responder cell frequency assay [ Time Frame: 3 weeks post-vaccination ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: November 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VZV vaccine
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).

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01262300

Contacts
Contact: Adit A Ginde, MD, MPH 720-848-6777 adit.ginde@ucdenver.edu

Locations
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Mucosal and Vaccine Research Colorado
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Adit A Ginde, MD, MPH University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01262300     History of Changes
Other Study ID Numbers: 10-0189
Study First Received: December 15, 2010
Last Updated: November 20, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Vitamin D
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 15, 2014