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

Shingles Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01262300
• Other study ID #: 10-0189
• Secondary ID: K23AG040708
• Status: Completed
• Phase: Phase 1
• Start date: November 2010
• Est. completion date: January 23, 2014

Study information

• Verified date: June 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: January 23, 2014
• Est. primary completion date: January 23, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chickenpox
• Herpes Zoster
• Immunosenescence
• Shingles

Intervention

Biological:
• Varicella Zoster Virus Vaccine (Zostavax)
Single 0.65 mL subcutaneous injection of the live, attenuated VZV zoster vaccine (Zostavax; Merck, Whitehouse Station, NJ).

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	Merck Sharp & Dohme Corp., National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VZV-specific cell mediated immunity, as measured by the interferon-? ELISPOT assay		3 weeks post-vaccination
Secondary	VZV-gpELISA to measure the VZV-specific antibody concentration		3 weeks post-vaccination
Secondary	VZV-specific effector and memory T cells		3 weeks post-vaccination
Secondary	-specific cell mediated immunity, as measured by the responder cell frequency assay		3 weeks post-vaccination