VZV PCR Sampling Validation Study

Completed

• Conditions: Herpes Zoster
• Interventions: Procedure: Herpes zoster sampling procedure for VZV PCR; Procedure: Blood sampling

• Registration Number: NCT00501670
• Lead Sponsor: GlaxoSmithKline

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2007-06-28
• Study First Submitted QC: 2007-07-13
• Study First Posted: 2007-07-16
• Study Start: 2007-08
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-09
• Last Update Posted: 2014-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• Clinically diagnosed with herpes zoster by the investigator including the presence of a typical herpes zoster rash.
• A male or female aged 50 years or older at the time of the subject's enrolment.
• Written informed consent obtained from the subject.
• Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.

Exclusion Criteria

• Any malignancy for which the subject is receiving active treatment, or any haematological malignancy.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccination, including corticosteroids, except inhaled and topical steroids are allowed.
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
• Previous vaccination against herpes zoster.
• Confirmed or suspected immunosuppression, based on medical history or physical examination (no laboratory testing required).
• A family history of congenital or hereditary immunodeficiency.
• History of or chronic alcohol or drug abuse.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A	Herpes zoster sampling procedure for VZV PCR	Collection of lesion samples and blood sampling from subjects aged \>=50 years with clinically diagnosed herpes zoster
Group A	Blood sampling	Collection of lesion samples and blood sampling from subjects aged \>=50 years with clinically diagnosed herpes zoster

Primary Outcome Measures

Name	Time	Method
Number of HSV DNA copies per clinical sample collected.	At the time of the clinical diagnosis of HZ (Month 0).
Number of VZV 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).

Secondary Outcome Measures

Name	Time	Method
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.
Anti-VZV Ab concentrations.	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.
Anti-gE Ab concentrations.	At Months 0 and 1.
Frequencies of gE-specific memory B cells.	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.	At Months 0 and 1.

Trial Locations

Locations (1)

GSK Investigational Site; 🇩🇪 Hamburg, Germany