Last updated: 11/03/2018 10:43:03
VZV PCR sampling validation study
GSK study ID
109999
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
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
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of VZV DNA copies per clinical sample collected.
Timeframe: At the time of the clinical diagnosis of HZ (Month 0).
Number of HSV DNA copies per clinical sample collected.
Timeframe: At the time of the clinical diagnosis of HZ (Month 0).
Number of actin DNA copies per clinical sample collected.
Timeframe: At the time of the clinical diagnosis of HZ (Month 0).
Secondary outcomes:
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.
Timeframe: 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.
Timeframe: At Months 0 and 1.
Anti-gE Ab concentrations.
Timeframe: At Months 0 and 1.
Anti-VZV Ab concentrations.
Timeframe: At Months 0 and 1.
Frequencies of gE-specific memory B cells.
Timeframe: At Months 0 and 1.
Frequencies of VZV-specific memory B cells.
Timeframe: At Months 0 and 1.
Occurrence of all SAEs.
Timeframe: During the whole study period.
Interventions:
Procedure/surgery: Herpes zoster sampling procedure for VZV PCR
Procedure/surgery: Blood sampling
Enrollment:
41
Observational study model:
Case-Only
Primary completion date:
2007-21-12
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Herpes Zoster
Product
GSK1437173A, GSK324332A
Collaborators
Not applicable
Study date(s)
August 2007 to December 2007
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
50+ years
Accepts healthy volunteers
No
- 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.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Clinically diagnosed with herpes zoster by the investigator including the presence of a typical herpes zoster rash.
Exclusion criteria:
- 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.
Any malignancy for which the subject is receiving active treatment, or any haematological malignancy.
Trial location(s)
Location
GSK Investigational Site
Kiel, Schleswig-Holstein, Germany, 24148
Status
Study Complete
Location
GSK Investigational Site
Husum, Schleswig-Holstein, Germany, 25813
Status
Terminated/Withdrawn
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Finalized
Actual primary completion date
2007-21-12
Actual study completion date
2007-21-12
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website