VZV PCR Sampling Validation Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00501670
First received: June 28, 2007
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Herpes Zoster
Procedure: Herpes zoster sampling procedure for VZV PCR
Procedure: Blood sampling

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of VZV DNA copies per clinical sample collected. [ Time Frame: At the time of the clinical diagnosis of HZ (Month 0). ] [ Designated as safety issue: No ]
  • Number of HSV DNA copies per clinical sample collected. [ Time Frame: At the time of the clinical diagnosis of HZ (Month 0). ] [ Designated as safety issue: No ]
  • Number of actin DNA copies per clinical sample collected. [ Time Frame: At the time of the clinical diagnosis of HZ (Month 0). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: At Months 0 and 1. ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: At Months 0 and 1. ] [ Designated as safety issue: No ]
  • Anti-gE Ab concentrations. [ Time Frame: At Months 0 and 1. ] [ Designated as safety issue: No ]
  • Anti-VZV Ab concentrations. [ Time Frame: At Months 0 and 1. ] [ Designated as safety issue: No ]
  • Frequencies of gE-specific memory B cells. [ Time Frame: At Months 0 and 1. ] [ Designated as safety issue: No ]
  • Frequencies of VZV-specific memory B cells. [ Time Frame: At Months 0 and 1. ] [ Designated as safety issue: No ]
  • Occurrence of all SAEs. [ Time Frame: During the whole study period. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

lesion samples


Enrollment: 41
Study Start Date: August 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Four types of HZ lesions will be collected (Swabs of vesicles, Swabs of papules, Swabs of crusts and Crusts), 3 replicates of each.
Procedure: Blood sampling
Two blood samples taken, the first at the time of HZ diagnosis and the second one month later.

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00501670

Locations
Germany
GSK Investigational Site
Husum, Schleswig-Holstein, Germany, 25813
GSK Investigational Site
Kiel, Schleswig-Holstein, Germany, 24148
GSK Investigational Site
Hamburg, Germany, 22143
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00501670     History of Changes
Other Study ID Numbers: 109999
Study First Received: June 28, 2007
Last Updated: January 9, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by GlaxoSmithKline:
Herpes zoster
PCR
Varicella zoster Virus (VZV)
Shingles
GSK Biologicals

Additional relevant MeSH terms:
Herpes Zoster
DNA Virus Infections
Herpesviridae Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 30, 2014