Varicella
Conditions
Brief summary
This study is conducted in order to collect clinical samples from patients who are diagnosed of having chickenpox infection. The results of this study will provide basic scientific information about chickenpox disease.
Detailed description
The study involves NO therapeutic or prophylactic treatment nor further observation of the patients. There is no product to be tested in this study.
Interventions
PROCEDURECollection of clinical samples
The following samples were obtained from each subject: * Vesicle fluid (VF) and vesicle swabs (VS) from four vesicles (for a total of eight samples) * Papule swabs (PS) from four papules * Crusts from two lesions * One throat swab (TS) Up to 15 samples were to be obtained for each subject, when possible. VFs, VSs, PSs, and crusts were either stored dry or in liquid medium. TS samples were stored in liquid medium. After extraction of DNA, samples were tested for the presence of varicella virus using a Quantitative Polymerase Chain Reaction (Q-PCR) technique.
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 16 Years
Healthy volunteers
No
Inclusion criteria
Pediatric patients who are diagnosed of having varicella and are presenting varicella dermal lesions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Viral Load: Number of Varicella Zoster Virus (VZV) Deoxyribonucleic Acid (DNA) Copies Per Clinical Sample | At Visit 1 (Day 0) | 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 |
| Viral Load: Number of Varicella Zoster Virus (VZV) Deoxyribonucleic Acid (DNA) Copies Per Clinical Sample by Storage Condition (Dry, Liquid) | At Visit 1 (Day 0) | 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. |
| Estimated Mean Viral Load (in log10) by Sample Types (Papule Swab, Vesicle Fluid and Vesicle Swab) | At Visit 1 (Day 0) | 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. |
Countries
Czechia
Participant flow
Recruitment details
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
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Varicella Group Subjects aged between 0 and 16 years of age, with clinically-diagnosed primary varicella disease. | 36 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | VZV DNA negative | 1 |
Baseline characteristics
| Characteristic | Varicella Group |
|---|---|
| Age, Continuous | 5.33 Years |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Estimated Mean Viral Load (in log10) by Sample Types (Papule Swab, Vesicle Fluid and Vesicle Swab)
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.
Time frame: At Visit 1 (Day 0)
Population: Only VZV DNA-positive samples were considered in this analysis.
| Arm | Measure | Group | Value (LOG_MEAN) |
|---|---|---|---|
| Varicella Group | 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 |
| Varicella Group | 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 |
| Varicella Group | 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 |
p-value: 0.003895% CI: [-0.769, -0.1213]ANOVA
p-value: 0.00695% CI: [-0.7605, -0.1035]ANOVA
p-value: 0.995295% CI: [-0.3171, 0.3435]ANOVA
Comparison: Geometric mean ratio of viral load (Papule swab over Vesicle fluid)95% CI: [0.17, 0.76]ANOVA
Comparison: Geometric mean ratio of viral load (Papule swab over Vesicle swab)95% CI: [0.17, 0.79]ANOVA
Comparison: Geometric mean ratio of viral load (Vesicle fluid over Vesicle swab)95% CI: [0.48, 2.21]ANOVA
Primary
Viral Load: Number of Varicella Zoster Virus (VZV) Deoxyribonucleic Acid (DNA) Copies Per Clinical Sample
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
Time frame: 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.
| Arm | Measure | Group | Value (LOG_MEAN) |
|---|---|---|---|
| Varicella Group | 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 |
| Varicella Group | 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 |
| Varicella Group | 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 |
| Varicella Group | 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 |
| Varicella Group | 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 |
| Varicella Group | 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 |
| Varicella Group | 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 |
| Varicella Group | 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 |
| Varicella Group | 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 |
Primary
Viral Load: Number of Varicella Zoster Virus (VZV) Deoxyribonucleic Acid (DNA) Copies Per Clinical Sample by Storage Condition (Dry, Liquid)
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.
Time frame: At Visit 1 (Day 0)
Population: Only VZV DNA-positive samples were considered in this analysis.
| Arm | Measure | Group | Value (LOG_MEAN) |
|---|---|---|---|
| Varicella Group | 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 |
| Varicella Group | 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 |
p-value: <0.0001ANOVA