VZV PCR Sampling Validation Study

NCT ID: NCT00501670

Last Updated: 2014-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

41 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-08-31

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Herpes Zoster

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A

Collection of lesion samples and blood sampling from subjects aged \>=50 years with clinically diagnosed herpes zoster

Herpes zoster sampling procedure for VZV PCR

Intervention Type PROCEDURE

Four types of HZ lesions will be collected (Swabs of vesicles, Swabs of papules, Swabs of crusts and Crusts), 3 replicates of each.

Blood sampling

Intervention Type PROCEDURE

Two blood samples taken, the first at the time of HZ diagnosis and the second one month later.

Interventions

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Herpes zoster sampling procedure for VZV PCR

Four types of HZ lesions will be collected (Swabs of vesicles, Swabs of papules, Swabs of crusts and Crusts), 3 replicates of each.

Intervention Type PROCEDURE

Blood sampling

Two blood samples taken, the first at the time of HZ diagnosis and the second one month later.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Hamburg, City state of Hamburg, Germany

Site Status

GSK Investigational Site

Husum, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Kiel, Schleswig-Holstein, Germany

Site Status

Countries

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Germany

Other Identifiers

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109999

Identifier Type: -

Identifier Source: org_study_id

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