Impact of Frailty on Immune Response to Varicella-Zoster Vaccination in Community-dwelling Older Adults; Pilot study
- Conditions
- Not Applicable
- Registration Number
- KCT0001807
- Lead Sponsor
- Seoul National University Bundang Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 69
Adults 65 years of age and older. Have given written informed consent prior to enrollment.
No history of herpes zoster within 5 years, no current history of immune suppression (e.g. malignancy or neoplastic disease, corticosteroid therapy).
No immunosuppression resulting from disease (e.g. malignancy, HIV infection), corticosteroids (except intermittent topical or inhaled corticosteroid = greater than 800mcg/day beclomethasone dipropionate or equivalent) or other immunosuppressive/cytotoxic therapy (cancer chemotherapy or organ transplantation).
No active neoplastic disease (except local skin cancer or prostate cancer that are stable in the absence of immunosuppressive/cytotoxic therapy).
No prior receipt of varicella vaccine.
No allergic sensitivity to neomycin.
No history of anaphylactoid reaction to gelatin.
No significant underlying illness that would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival to less than 6 months).
No receipt of any other immunizations within one month before study vaccination (2 weeks in the case of inactivated influenza vaccines or other non-replicating immunization products) or scheduled within 6 weeks after study vaccination.
No currently receiving antiviral therapy. No intercurrent illness (e.g. urinary tract infection, influenza) that might interfere with the interpretation of the study.
No subjects unlikely to adhere to protocol follow-up.
No subjects involved in a conflicting (vaccine) clinical trial.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference of immunogenicity will be compared according to the frailty status.
- Secondary Outcome Measures
Name Time Method Difference of antibody response according to the age group will be assessed.;Difference of immunogenicity will be compared according to the baseline cytokine level.