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

NCT ID: NCT01262300

Last Updated: 2021-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2014-01-23

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.

Detailed Description

Objectives

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.

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.

Conditions

Immunosenescence; Shingles

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Varicella Zoster Virus Vaccine (Zostavax)

Intervention Type: BIOLOGICAL

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

Interventions

Varicella Zoster Virus Vaccine (Zostavax)

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

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adit A Ginde, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Denver

Aurora, Colorado, United States

Countries

United States

References

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

Reference Type: BACKGROUND

Other Identifiers

K23AG040708

Identifier Type: NIH

Identifier Source: secondary_id

View Link

10-0189

Identifier Type: -

Identifier Source: org_study_id