Trial Outcomes & Findings for Detection and Characterisation of Varicella Zoster Virus From Dermal Lesions of Chickenpox-infected Patients (NCT NCT00127608)
NCT ID: NCT00127608
Last Updated: 2019-02-04
Results Overview
The estimated means of the viral load in log10 values for each storage condition (dry and liquid) and each type of sample are presented with 95% confidence intervals
COMPLETED
PHASE3
36 participants
At Visit 1 (Day 0)
2019-02-04
Participant Flow
Similar numbers of subjects presenting with different varicella rash intensities were enrolled: * Severe: more than 150 lesions on multiple parts of the body; rash is mostly vesicular * Moderate: 51 to 150 lesions; rash is vesicular and/or maculopapular * Mild: 1-50 lesions; rash is maculopapular rather than vesicular
Out of 503 samples collected, 6 were not received from the investigator and 12 were insufficient samples. Hence only 485 samples were tested by Q-PCR. All 13 samples from 1 subject were VZV DNA negative, suggesting the subject did not have varicella. Therefore, this subject was not included in the final analyses and hence not completed.
Unit of analysis: samples
Participant milestones
| Measure |
Varicella Group
Subjects aged between 0 and 16 years of age, with clinically-diagnosed primary varicella disease.
|
|---|---|
|
Overall Study
STARTED
|
36 503
|
|
Overall Study
COMPLETED
|
35 472
|
|
Overall Study
NOT COMPLETED
|
1 31
|
Reasons for withdrawal
| Measure |
Varicella Group
Subjects aged between 0 and 16 years of age, with clinically-diagnosed primary varicella disease.
|
|---|---|
|
Overall Study
VZV DNA negative
|
1
|
Baseline Characteristics
Detection and Characterisation of Varicella Zoster Virus From Dermal Lesions of Chickenpox-infected Patients
Baseline characteristics by cohort
| Measure |
Varicella Group
n=36 Participants
Subjects aged between 0 and 16 years of age, with clinically-diagnosed primary varicella disease.
|
|---|---|
|
Age, Continuous
|
5.33 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Visit 1 (Day 0)Population: One subject who was Varicella Zoster Virus (VZV) deoxyribonucleic acid (DNA)-negative in all samples taken, was considered not to have varicella and was not included in the analyses.
The estimated means of the viral load in log10 values for each storage condition (dry and liquid) and each type of sample are presented with 95% confidence intervals
Outcome measures
| Measure |
Varicella Group
n=472 samples
Subjects aged between 0 and 16 years of age, with clinically-diagnosed primary varicella disease.
|
|---|---|
|
Viral Load: Number of Varicella Zoster Virus (VZV) Deoxyribonucleic Acid (DNA) Copies Per Clinical Sample
Vesicle fluid (dry storage)
|
6.49 VZV genome copies per sample
Interval 4.58 to 7.58
|
|
Viral Load: Number of Varicella Zoster Virus (VZV) Deoxyribonucleic Acid (DNA) Copies Per Clinical Sample
Vesicle swab (dry storage)
|
6.46 VZV genome copies per sample
Interval 4.64 to 7.69
|
|
Viral Load: Number of Varicella Zoster Virus (VZV) Deoxyribonucleic Acid (DNA) Copies Per Clinical Sample
Papule swab (dry storage)
|
6.07 VZV genome copies per sample
Interval 3.93 to 7.43
|
|
Viral Load: Number of Varicella Zoster Virus (VZV) Deoxyribonucleic Acid (DNA) Copies Per Clinical Sample
Crust (dry storage)
|
6.02 VZV genome copies per sample
Interval 4.21 to 7.47
|
|
Viral Load: Number of Varicella Zoster Virus (VZV) Deoxyribonucleic Acid (DNA) Copies Per Clinical Sample
Vesicle fluid (liquid storage)
|
6.98 VZV genome copies per sample
Interval 5.74 to 7.91
|
|
Viral Load: Number of Varicella Zoster Virus (VZV) Deoxyribonucleic Acid (DNA) Copies Per Clinical Sample
Vesicle swab (liquid storage)
|
6.98 VZV genome copies per sample
Interval 5.62 to 7.99
|
|
Viral Load: Number of Varicella Zoster Virus (VZV) Deoxyribonucleic Acid (DNA) Copies Per Clinical Sample
Papule swab (liquid storage)
|
6.09 VZV genome copies per sample
Interval 5.03 to 8.21
|
|
Viral Load: Number of Varicella Zoster Virus (VZV) Deoxyribonucleic Acid (DNA) Copies Per Clinical Sample
Crust (liquid storage)
|
7.08 VZV genome copies per sample
Interval 4.98 to 8.1
|
|
Viral Load: Number of Varicella Zoster Virus (VZV) Deoxyribonucleic Acid (DNA) Copies Per Clinical Sample
Throat swab (liquid storage)
|
4.78 VZV genome copies per sample
Interval 2.93 to 7.15
|
PRIMARY outcome
Timeframe: At Visit 1 (Day 0)Population: Only VZV DNA-positive samples were considered in this analysis.
The estimated viral load was calculated by quantitative polymerase chain reaction assay (Q-PCR) in log10, as a mean number of viral copies per sample by storage conditions (dry, liquid). As throat swabs were not stored dry and the number of crust samples was lower than that of papules and vesicles, this analysis was done only on data from vesicle fluid, vesicle swabs and papule swabs.
Outcome measures
| Measure |
Varicella Group
n=383 samples
Subjects aged between 0 and 16 years of age, with clinically-diagnosed primary varicella disease.
|
|---|---|
|
Viral Load: Number of Varicella Zoster Virus (VZV) Deoxyribonucleic Acid (DNA) Copies Per Clinical Sample by Storage Condition (Dry, Liquid)
Dry storage
|
6.34 VZV genome copies per sample
Interval 6.18 to 6.5
|
|
Viral Load: Number of Varicella Zoster Virus (VZV) Deoxyribonucleic Acid (DNA) Copies Per Clinical Sample by Storage Condition (Dry, Liquid)
Liquid storage
|
6.82 VZV genome copies per sample
Interval 6.67 to 6.98
|
PRIMARY outcome
Timeframe: At Visit 1 (Day 0)Population: Only VZV DNA-positive samples were considered in this analysis.
The estimated viral load was calculated by quantitative polymerase chain reaction assay (Q-PCR) in log10, as a mean number of viral copies per sample by sample types (papule swab, vesicle fluid and vesicle swab). As throat swabs were not stored dry and the number of crust samples was lower than that of papules and vesicles, this analysis was done only on data from vesicle fluid, vesicle swabs and papule swabs.
Outcome measures
| Measure |
Varicella Group
n=383 samples
Subjects aged between 0 and 16 years of age, with clinically-diagnosed primary varicella disease.
|
|---|---|
|
Estimated Mean Viral Load (in log10) by Sample Types (Papule Swab, Vesicle Fluid and Vesicle Swab)
Papule swab (Dry or Liquid storage)
|
6.29 VZV genome copies per sample
Interval 6.1 to 6.48
|
|
Estimated Mean Viral Load (in log10) by Sample Types (Papule Swab, Vesicle Fluid and Vesicle Swab)
Vesicle fluid (Dry or Liquid storage)
|
6.74 VZV genome copies per sample
Interval 6.54 to 6.92
|
|
Estimated Mean Viral Load (in log10) by Sample Types (Papule Swab, Vesicle Fluid and Vesicle Swab)
Vesicle swab (Dry or Liquid storage)
|
6.72 VZV genome copies per sample
Interval 6.52 to 6.92
|
Adverse Events
Varicella Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER