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NCT Number: NCT00501670

VZV PCR Sampling Validation Study

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.

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Key information

Conditions

Herpes Zoster Chickenpox DNA Virus Infections Herpesviridae Infections Infections Varicella Zoster Virus Infection Virus Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site, Hamburg, Free and Hanseatic City of Hamburg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

blood sampling

Procedure

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

Primary outcomes

  1. Number of VZV DNA copies per clinical sample collected.

    Time frame: At the time of the clinical diagnosis of HZ (Month 0).

  2. Number of HSV DNA copies per clinical sample collected.

    Time frame: At the time of the clinical diagnosis of HZ (Month 0).

  3. Number of actin DNA copies per clinical sample collected.

    Time frame: At the time of the clinical diagnosis of HZ (Month 0).

Secondary outcomes

  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 gE.

    Time frame: At Months 0 and 1.

  2. 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.

  3. Anti-gE Ab concentrations.

    Time frame: At Months 0 and 1.

  4. Anti-VZV Ab concentrations.

    Time frame: At Months 0 and 1.

  5. Frequencies of gE-specific memory B cells.

    Time frame: At Months 0 and 1.

  6. Frequencies of VZV-specific memory B cells.

    Time frame: At Months 0 and 1.

  7. Occurrence of all SAEs.

    Time frame: During the whole study period.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jul 16, 2007
Registry last updated
Jan 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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