VZV PCR Sampling Validation Study

NCT00501670 | Completed

• 1 other identifier: 109999
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 3

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.

Conditions

Herpes Zoster

Keywords

Herpes zoster; PCR; Varicella zoster Virus (VZV); Shingles; GSK Biologicals

Outcome Measures

Primary Outcomes (3)

• 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).

Secondary Outcomes (7)

• 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.

  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.

Study Arms (1)

Group A

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

Procedure: Herpes zoster sampling procedure for VZV PCR; Procedure: Blood sampling

Interventions

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.

Group A

Blood sampling PROCEDURE

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

Group A

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Hamburg, Hamburg, 22143, Germany

Location

GSK Investigational Site

Husum, Schleswig-Holstein, 25813, Germany

Location

GSK Investigational Site

Kiel, Schleswig-Holstein, 24148, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

lesion samples

MeSH Terms

Conditions

Herpes Zoster; Chickenpox

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2007
• First Posted: July 16, 2007
• Study Start: August 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: January 13, 2014

Record last verified: 2014-01

Locations

DE (3)