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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Collection of lesion samples and blood sampling from subjects aged >=50 years with clinically diagnosed herpes zoster |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Herpes zoster sampling procedure for VZV PCR | Procedure | Four types of HZ lesions will be collected (Swabs of vesicles, Swabs of papules, Swabs of crusts and Crusts), 3 replicates of each. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of VZV DNA copies per clinical sample collected. | At the time of the clinical diagnosis of HZ (Month 0). | |
| Number of HSV DNA copies per clinical sample collected. | At the time of the clinical diagnosis of HZ (Month 0). | |
| Number of actin DNA copies per clinical sample collected. | At the time of the clinical diagnosis of HZ (Month 0). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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German male or female patients aged 50 years or older who are clinically diagnosed with HZ by the investigator including the presence of a typical HZ rash.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Hamburg | Free and Hanseatic City of Hamburg | 22143 | Germany | ||
| GSK Investigational Site |
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| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| D002644 | Chickenpox |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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lesion samples
| Blood sampling | Procedure | Two blood samples taken, the first at the time of HZ diagnosis and the second one month later. |
|
| At Months 0 and 1. |
| Anti-gE Ab concentrations. | At Months 0 and 1. |
| Anti-VZV Ab concentrations. | At Months 0 and 1. |
| Frequencies of gE-specific memory B cells. | At Months 0 and 1. |
| Frequencies of VZV-specific memory B cells. | At Months 0 and 1. |
| Occurrence of all SAEs. | During the whole study period. |
| Husum |
| Schleswig-Holstein |
| 25813 |
| Germany |
| GSK Investigational Site | Kiel | Schleswig-Holstein | 24148 | Germany |
| D007239 | Infections |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |