Herpes ZosterNCT00501670
VZV PCR Sampling Validation Study
An observational study of Herpes Zoster, run by GlaxoSmithKline at 3 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- Herpes zoster sampling procedure for VZV PCR and Blood sampling
- Type of treatment
- Surgery or procedure
- How many people
- 41 participants
- Where
- 3 sitesGermany
- Study dates
- Aug 2007to Dec 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 22143
GSK Investigational Site
Husum, Schleswig-Holstein, 25813
GSK Investigational Site
Kiel, Schleswig-Holstein, 24148
About this study
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
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.
Read the 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.
- Conditions
- Herpes Zoster
- Being tested
- Herpes zoster sampling procedure for VZV PCR, Blood sampling
- Keywords
- Herpes zoster, PCR, Varicella zoster Virus (VZV), Shingles, GSK Biologicals
- Medical subject headings
- Herpes Zoster, Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herpes zoster sampling procedure for VZV PCRProcedure or surgery
Four types of HZ lesions will be collected (Swabs of vesicles, Swabs of papules, Swabs of crusts and Crusts), 3 replicates of each.
Blood samplingProcedure or surgery
Two blood samples taken, the first at the time of HZ diagnosis and the second one month later.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Collection of lesion samples and blood sampling from subjects aged >=50 years with clinically diagnosed herpes zoster Receives: Procedure: Herpes zoster sampling procedure for VZV PCR; Procedure: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of VZV DNA copies per clinical sample collected.
Measured: At the time of the clinical diagnosis of HZ (Month 0).
Number of HSV DNA copies per clinical sample collected.
Measured: At the time of the clinical diagnosis of HZ (Month 0).
Number of actin DNA copies per clinical sample collected.
Measured: 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.
Measured: 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.
Measured: At Months 0 and 1.
Anti-gE Ab concentrations.
Measured: At Months 0 and 1.
Anti-VZV Ab concentrations.
Measured: At Months 0 and 1.
Frequencies of gE-specific memory B cells.
Measured: At Months 0 and 1.
Frequencies of VZV-specific memory B cells.
Measured: At Months 0 and 1.
Occurrence of all SAEs.
Measured: During the whole study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2007 (estimated)
- Study startAug 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00501670
- Sponsor's protocol ID
- 109999
- Status last verified
- Jan 2014
- First submitted
- 28 Jun 2007
- Last updated
- 13 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00501670
- Acronym / sponsor ID
- 109999
- Conditions
- Herpes Zoster
- Keywords
- Herpes zoster, PCR, Varicella zoster Virus (VZV), Shingles, GSK Biologicals
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 16 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Procedure: Herpes zoster sampling procedure for VZV PCR, Procedure: Blood samplingCollection of lesion samples and blood sampling from subjects aged >=50 years with clinically diagnosed herpes zoster |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Herpes zoster sampling procedure for VZV PCRFour types of HZ lesions will be collected (Swabs of vesicles, Swabs of papules, Swabs of crusts and Crusts), 3 replicates of each. | Procedure or surgery | Group A |
| Blood samplingTwo blood samples taken, the first at the time of HZ diagnosis and the second one month later. | Procedure or surgery | Group A |
Primary outcome
Number of VZV DNA copies per clinical sample collected.
Time frame: At the time of the clinical diagnosis of HZ (Month 0).
Number of HSV DNA copies per clinical sample collected.
Time frame: At the time of the clinical diagnosis of HZ (Month 0).
Number of actin DNA copies per clinical sample collected.
Time frame: At the time of the clinical diagnosis of HZ (Month 0).
7 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.
Time frame: 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.
Time frame: At Months 0 and 1.
Anti-gE Ab concentrations.
Time frame: At Months 0 and 1.
Anti-VZV Ab concentrations.
Time frame: At Months 0 and 1.
Frequencies of gE-specific memory B cells.
Time frame: At Months 0 and 1.
Frequencies of VZV-specific memory B cells.
Time frame: At Months 0 and 1.
Occurrence of all SAEs.
Time frame: During the whole study period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Herpes Zoster, run by GlaxoSmithKline at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of VZV DNA copies per clinical sample collected. (time frame: At the time of the clinical diagnosis of HZ (Month 0).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2014; AzTrials last refreshed its copy on 28 Oct 2026.