VZV PCR Sampling Validation Study

Herpes Zoster Clinical Trial

Official title:

A Non-therapeutic Study to Validate the Sampling Method to Confirm Presence of Varicella-zoster Virus (VZV) DNA by PCR in Clinical Samples From Lesions Collected From Adults (≥50 Years) With Clinically Diagnosed Herpes Zoster

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00501670
• Other study ID #: 109999
• Status: Completed
• Phase: N/A
• First received: June 28, 2007
• Last updated: January 9, 2014
• Start date: August 2007
• Est. completion date: December 2007

Study information

• Verified date: January 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Herpes Zoster

Intervention

Procedure:
• 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.
• Blood sampling
Two blood samples taken, the first at the time of HZ diagnosis and the second one month later.

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Husum	Schleswig-Holstein
Germany	GSK Investigational Site	Kiel	Schleswig-Holstein

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of VZV DNA copies per clinical sample collected.		At the time of the clinical diagnosis of HZ (Month 0).	No
Primary	Number of HSV DNA copies per clinical sample collected.		At the time of the clinical diagnosis of HZ (Month 0).	No
Primary	Number of actin DNA copies per clinical sample collected.		At the time of the clinical diagnosis of HZ (Month 0).	No
Secondary	Frequencies of CD4/CD8 T cells with antigen-specific IFN-g and/or IL-2 and/or TNF-a and/or CD40L secretion/expression to gE.		At Months 0 and 1.	No
Secondary	Frequencies of CD4/CD8 T cells with antigen-specific IFN-g and/or IL-2 and/or TNF-a and/or CD40L secretion/expression to VZV.		At Months 0 and 1.	No
Secondary	Anti-gE Ab concentrations.		At Months 0 and 1.	No
Secondary	Anti-VZV Ab concentrations.		At Months 0 and 1.	No
Secondary	Frequencies of gE-specific memory B cells.		At Months 0 and 1.	No
Secondary	Frequencies of VZV-specific memory B cells.		At Months 0 and 1.	No
Secondary	Occurrence of all SAEs.		During the whole study period.	No