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

NCT01262300 | Completed Phase 1

• 2 other identifiers: 10-0189K23AG040708
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Immunosenescence; Shingles

Keywords

Immunosenescence; Shingles; Vitamin D; Varicella Zoster Virus; Vaccine; Immune Response; Geriatrics

Outcome Measures

Primary Outcomes (1)

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

  3 weeks post-vaccination

Secondary Outcomes (3)

• VZV-gpELISA to measure the VZV-specific antibody concentration

  3 weeks post-vaccination

• VZV-specific effector and memory T cells

  3 weeks post-vaccination

• -specific cell mediated immunity, as measured by the responder cell frequency assay

  3 weeks post-vaccination

Study Arms (1)

VZV vaccine

EXPERIMENTAL

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)

Interventions

Varicella Zoster Virus Vaccine (Zostavax) BIOLOGICAL

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

VZV vaccine

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥ 60 years;
• Residing in a long-term care facility;
• Have not yet received VZV vaccine

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute on Aging (NIA): collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

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

  BACKGROUND

MeSH Terms

Conditions

Herpes Zoster; Chickenpox

Interventions

Herpes Zoster Vaccine

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Chickenpox Vaccine; Herpesvirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Adit A Ginde, MD, MPH

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2010
• First Posted: December 17, 2010
• Study Start: November 1, 2010
• Primary Completion: January 23, 2014
• Study Completion: January 23, 2014
• Last Updated: June 25, 2021

Record last verified: 2021-06

Locations

US (1)