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

This study is currently recruiting participants. (see Contacts and Locations)
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

December 15, 2010
November 20, 2012
November 2010
August 2014   (final data collection date for primary outcome measure)
VZV-specific cell mediated immunity, as measured by the interferon-γ ELISPOT assay [ Time Frame: 3 weeks post-vaccination ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01262300 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Vitamin D Supplementation And Varicella Zoster Virus Vaccine Responsiveness In Older Long-Term Care Residents
Not Provided

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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Immunosenescence
  • Shingles
Biological: Varicella Zoster Virus Vaccine (Zostavax)
Single 0.65 mL subcutaneous injection of the live, attenuated VZV zoster vaccine (Zostavax; Merck, Whitehouse Station, NJ).
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.
Intervention: Biological: Varicella Zoster Virus Vaccine (Zostavax)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
December 2014
August 2014   (final data collection date for primary outcome measure)

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.

Both
60 Years and older
No
Contact: Adit A Ginde, MD, MPH 720-848-6777 adit.ginde@ucdenver.edu
United States
 
NCT01262300
10-0189
No
University of Colorado, Denver
University of Colorado, Denver
  • National Institute on Aging (NIA)
  • Mucosal and Vaccine Research Colorado
  • Merck Sharp & Dohme Corp.
Principal Investigator: Adit A Ginde, MD, MPH University of Colorado, Denver
University of Colorado, Denver
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP