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:
University of Colorado, Denver
Collaborators:
Mucosal and Vaccine Research Colorado
Merck
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
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Purpose
Objectives
- 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.
- 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.
- 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
- At baseline, higher serum 25(OH)D levels will be associated with higher levels of VZV-specific cell-mediated immunity (cross-sectional).
- 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.
- 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
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 May 21, 2013