ImmunosenescencePhase 1NCT01262300
Vitamin D Supplementation And Varicella Zoster Virus Vaccine Responsiveness In Older Long-Term Care Residents
A Phase 1 study testing Varicella Zoster Virus Vaccine (Zostavax) in people with Immunosenescence and Shingles, run by University of Colorado, Denver at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Immunosenescence, Shingles
- What is being tested?
- Varicella Zoster Virus Vaccine (Zostavax)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to 23 Jan 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 60 years;
- Residing in a long-term care facility;
- Have not yet received VZV vaccine
Who cannot join
- 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);
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- 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;
- known allergy to gelatin, neomycin, or any other component of the vaccine.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
Official title: Vitamin D Supplementation And Varicella Zoster Virus Vaccine Responsiveness In Older Nursing Home Residents
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.
Read the detailed description
Objectives
- 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.
- 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.
- Conditions
- Immunosenescence, Shingles
- Being tested
- Varicella Zoster Virus Vaccine (Zostavax)
- Keywords
- Immunosenescence, Shingles, Vitamin D, Varicella Zoster Virus, Vaccine, Immune Response, Geriatrics
- Medical subject headings
- Herpes Zoster, Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Varicella Zoster Virus Vaccine (Zostavax)Biological
Single 0.65 mL subcutaneous injection of the live, attenuated VZV zoster vaccine (Zostavax; Merck, Whitehouse Station, NJ).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Varicella Zoster Virus Vaccine (Zostavax) |
What is being measured
The primary outcome is the main question the study is designed to answer.
VZV-specific cell mediated immunity, as measured by the interferon-γ ELISPOT assay
Measured: 3 weeks post-vaccination
Secondary outcomes (3)
VZV-gpELISA to measure the VZV-specific antibody concentration
Measured: 3 weeks post-vaccination
VZV-specific effector and memory T cells
Measured: 3 weeks post-vaccination
-specific cell mediated immunity, as measured by the responder cell frequency assay
Measured: 3 weeks post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study startNov 2010
- Primary completion23 Jan 2014
- Study completion23 Jan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ImmunosenescenceStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Adit A Ginde, MD, MPH, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01262300
- Sponsor's protocol ID
- 10-0189
- Other IDs
- K23AG040708
- Status last verified
- Jun 2021
- First submitted
- 15 Dec 2010
- Last updated
- 25 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
A randomized controlled trial of high dose vitamin D in older long-term care residents (NCT01102374)
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Supplementation And Varicella Zoster Virus Vaccine Responsiveness In Older Nursing Home Residents
- ClinicalTrials.gov ID
- NCT01262300
- Acronym / sponsor ID
- 10-0189
- Conditions
- Immunosenescence, Shingles
- Keywords
- Immunosenescence, Shingles, Vitamin D, Varicella Zoster Virus, Vaccine, Immune Response, Geriatrics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Merck Sharp & Dohme LLC
- Study start
- Nov 2010
- Primary completion
- 23 Jan 2014 (actual)
- Study completion
- 23 Jan 2014 (actual)
- First posted
- 17 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VZV vaccine | Experimental | Biological: Varicella Zoster Virus Vaccine (Zostavax)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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged ≥ 60 years;
- Residing in a long-term care facility;
- Have not yet received VZV vaccine
Key exclusion criteria (16 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Varicella Zoster Virus Vaccine (Zostavax)Single 0.65 mL subcutaneous injection of the live, attenuated VZV zoster vaccine (Zostavax; Merck, Whitehouse Station, NJ). | Biological | VZV vaccine |
Primary outcome
VZV-specific cell mediated immunity, as measured by the interferon-γ ELISPOT assay
Time frame: 3 weeks post-vaccination
3 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2021.
- BackgroundA randomized controlled trial of high dose vitamin D in older long-term care residents (NCT01102374)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adit A Ginde, MD, MPH principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Varicella Zoster Virus Vaccine (Zostavax) in people with Immunosenescence and Shingles, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VZV-specific cell mediated immunity, as measured by the interferon-γ ELISPOT assay (time frame: 3 weeks post-vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01262300, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2021.