This trial is active, not recruiting.

Conditions immunosenescence, shingles
Treatment varicella zoster virus vaccine (zostavax)
Phase phase 1
Sponsor University of Colorado, Denver
Collaborator National Institute on Aging (NIA)
Start date November 2010
End date November 2014
Trial size 33 participants
Trial identifier NCT01262300, 10-0189


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 we will determine the immunological response to the vaccine in this older, frail population, as well as the association between vitamin D and immunological outcomes.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention
Varicella Zoster Virus vaccine (Zostavax), single dose X 1 injection 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.
varicella zoster virus vaccine (zostavax)
Single 0.65 mL subcutaneous injection of the live, attenuated VZV zoster vaccine (Zostavax; Merck, Whitehouse Station, NJ).

Primary Outcomes

VZV-specific cell mediated immunity, as measured by the interferon-γ ELISPOT assay
time frame: 3 weeks post-vaccination

Secondary Outcomes

VZV-gpELISA to measure the VZV-specific antibody concentration
time frame: 3 weeks post-vaccination
VZV-specific effector and memory T cells
time frame: 3 weeks post-vaccination
-specific cell mediated immunity, as measured by the responder cell frequency assay
time frame: 3 weeks post-vaccination

Eligibility Criteria

Male or female participants at least 60 years old.

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.

Additional Information

Official title Vitamin D Supplementation And Varicella Zoster Virus Vaccine Responsiveness In Older Nursing Home Residents
Principal investigator Adit A Ginde, MD, MPH
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Colorado, Denver.