This study will evaluate and compare various methods for collecting lesion samples from subjects with clinically diagnosed herpes zoster for the laboratory confirmation of herpes zoster. The samples will be tested by polymerase chain reaction (PCR) to detect VZV DNA. Multiple samples from each type of herpes zoster lesion will be collected in order to determine whether the analysis of duplicate samples enhances the sensitivity of VZV DNA detection for the diagnosis of herpes zoster. In addition, blood will be collected for the evaluation of VZV immunity at the time of the initial herpes zoster sample collection (after herpes zoster has been clinically diagnosed) and one month later in order to establish the range of cellular and humoral immune responses during natural herpes zoster in adults ≥50 years old.
This non-prophylactic, non-therapeutic study involves NO treatment of study participants. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study Type
OBSERVATIONAL
Enrollment
41
Four types of HZ lesions will be collected (Swabs of vesicles, Swabs of papules, Swabs of crusts and Crusts), 3 replicates of each.
Two blood samples taken, the first at the time of HZ diagnosis and the second one month later.
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, Germany
GSK Investigational Site
Husum, Schleswig-Holstein, Germany
GSK Investigational Site
Kiel, Schleswig-Holstein, Germany
Number of VZV DNA copies per clinical sample collected.
Time frame: At the time of the clinical diagnosis of HZ (Month 0).
Number of HSV DNA copies per clinical sample collected.
Time frame: At the time of the clinical diagnosis of HZ (Month 0).
Number of actin DNA copies per clinical sample collected.
Time frame: At the time of the clinical diagnosis of HZ (Month 0).
Frequencies of CD4/CD8 T cells with antigen-specific IFN-g and/or IL-2 and/or TNF-α and/or CD40L secretion/expression to gE.
Time frame: At Months 0 and 1.
Frequencies of CD4/CD8 T cells with antigen-specific IFN-g and/or IL-2 and/or TNF-α and/or CD40L secretion/expression to VZV.
Time frame: At Months 0 and 1.
Anti-gE Ab concentrations.
Time frame: At Months 0 and 1.
Anti-VZV Ab concentrations.
Time frame: At Months 0 and 1.
Frequencies of gE-specific memory B cells.
Time frame: At Months 0 and 1.
Frequencies of VZV-specific memory B cells.
Time frame: At Months 0 and 1.
Occurrence of all SAEs.
Time frame: During the whole study period.
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