N/A
Completed N=241
Zoster Vaccine Response in the Frail Elderly
Immune System Diseases
Source: ClinicalTrials.gov NCT01328548 ↗
Enrolled (actual)
241
Serious AEs
1.2%
Results posted
Apr 2017
Primary outcomePrimary: Change From Baseline in T-cell Response to the VZV Vaccine in the Frail Elderly — 50.17; 78.17; 83.22; 120.56 Spot Forming Units per 10^6 PBMC
Summary
This study is being done to evaluate the zoster vaccine response in the nursing home elderly (80 years or older). As the immune system ages, the response to vaccines is not always as strong as in younger people. Previous zoster vaccine studies have excluded nursing home residents so the vaccine effect in this population is not known. Furthermore, the immune and genetic reasons as to why the vaccine works well in some people but not in others are also unknown. The goal of this study is to evaluate why some immune systems respond well to the vaccine and why others do not.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in T-cell Response to the VZV Vaccine in the Frail Elderly |
50.17; 78.17; 83.22; 120.56 | — |
| PRIMARY Assessment of Immune Parameters Compatible With Inflammaging: CD4+/CD8+ Ratio |
3.06 | — |
| PRIMARY Assessment of Immune Parameters Compatible With Inflammaging: High T Regulatory Cells |
2.23 | — |
Eligibility Criteria
Inclusion Criteria
- nursing home resident
- greater than or equal to 80 years old
- non-ambulatory
Exclusion Criteria
- less than 80 years old
- ambulatory
- taking immunosuppressive medication
- history of primary or acquired immuno-deficiency states including leukemia, other malignant neoplasms affecting the bone marrow or lymphatic system, and AIDS
- active untreated tuberculosis
- previous receipt of varicella vaccine
- residents expected to expire within 30 days, in the opinion of the most responsible physician
- residents planning to move nursing homes within the year
- temporary residents
Data sourced from ClinicalTrials.gov (NCT01328548). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.