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VZV PCR Sampling Validation Study

2014-08-27 03:37:22 | BioPortfolio

Summary

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.

Description

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Conditions

Herpes Zoster (Shingles)

Intervention

Blood sampling, Herpes zoster sampling procedure for VZV PCR

Location

GSK Investigational Site
Kiel
Schleswig-Holstein
Germany
24148

Status

Completed

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:37:22-0400

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Medical and Biotech [MESH] Definitions

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