Trial Outcomes & Findings for A Study in Adult Subjects With Chronic Hepatitis B Infection to Support the Development of Immunological Assays (NCT NCT01098006)
NCT ID: NCT01098006
Last Updated: 2020-02-25
Results Overview
The frequency was assessed based on the following range of markers: CD4, CD45RA, ICOS, HLA-DR, PD-1 and anti-Foxp3.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
99 participants
Primary outcome timeframe
At the time of the visit for each subject (i.e., Day 0)
Results posted on
2020-02-25
Participant Flow
The study period (i.e., from study initiation until study completion) was approximately 22 months (i.e., from April-2010 until February-2012). The duration of the study was one day for each subject.
All 99 subjects enrolled in the study were included in the analysis.
Participant milestones
| Measure |
Immune Tolerant Patients Group
Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
|
HBeAg Positive Group
HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
|
Inactive Carriers Group
Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
|
HBeAg Negative Group
HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
11
|
60
|
21
|
|
Overall Study
COMPLETED
|
7
|
11
|
60
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study in Adult Subjects With Chronic Hepatitis B Infection to Support the Development of Immunological Assays
Baseline characteristics by cohort
| Measure |
Immune Tolerant Patients Group
n=7 Participants
Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
|
HBeAg Positive Group
n=11 Participants
HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
|
Inactive Carriers Group
n=60 Participants
Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
|
HBeAg Negative Group
n=21 Participants
HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
26.4 Years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
34.0 Years
STANDARD_DEVIATION 14.2 • n=7 Participants
|
36.9 Years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
39.7 Years
STANDARD_DEVIATION 15.1 • n=4 Participants
|
36.43 Years
STANDARD_DEVIATION 11.19 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
62 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Geographic Ancestry · African heritage/African American
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Geographic Ancestry · Asian-Central/South Asian heritage
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Geographic Ancestry · Asian-East Asian heritage
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Geographic Ancestry · White-Arabic/North African heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Geographic Ancestry · White-Caucasian/European heritage
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Geographic Ancestry · Other: Kazakstan
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Geographic Ancestry · Other: Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: At the time of the visit for each subject (i.e., Day 0)Population: The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.
The frequency was assessed based on the following range of markers: CD4, CD45RA, ICOS, HLA-DR, PD-1 and anti-Foxp3.
Outcome measures
| Measure |
Immune Tolerant Patients Group
n=4 Participants
Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
|
HBeAg Positive Group
n=10 Participants
HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
|
Inactive Carriers Group
n=56 Participants
Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
|
HBeAg Negative Group
n=19 Participants
HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
|
|---|---|---|---|---|
|
Frequency of Cluster of Differentiation 4 (CD4) + Forkhead Box p3 (Foxp3) + Expressing CD45RA and/or Human Leucocyte Antigen DR Complex (HLA-DR) and/or Inducible T Cell Co-stimulator (ICOS) and/or PD1
CD4+FOXP3+
|
5.025 Treg cells/million cells
Interval 4.53 to 5.295
|
6.275 Treg cells/million cells
Interval 5.07 to 6.51
|
4.185 Treg cells/million cells
Interval 3.39 to 6.16
|
4.93 Treg cells/million cells
Interval 4.0 to 6.16
|
|
Frequency of Cluster of Differentiation 4 (CD4) + Forkhead Box p3 (Foxp3) + Expressing CD45RA and/or Human Leucocyte Antigen DR Complex (HLA-DR) and/or Inducible T Cell Co-stimulator (ICOS) and/or PD1
CD4+FOXP3+CD45RA+
|
16.7 Treg cells/million cells
Interval 8.53 to 28.9
|
16 Treg cells/million cells
Interval 9.79 to 29.1
|
18 Treg cells/million cells
Interval 14.4 to 29.25
|
16.2 Treg cells/million cells
Interval 10.4 to 25.4
|
|
Frequency of Cluster of Differentiation 4 (CD4) + Forkhead Box p3 (Foxp3) + Expressing CD45RA and/or Human Leucocyte Antigen DR Complex (HLA-DR) and/or Inducible T Cell Co-stimulator (ICOS) and/or PD1
CD4+FOXP3+CD45RA+HLADR+ICOS+PD1-
|
0.1299 Treg cells/million cells
Interval 0.0785 to 1.769
|
0.0702 Treg cells/million cells
Interval 0.0001 to 0.122
|
0.1755 Treg cells/million cells
Interval 0.07 to 0.3
|
0.113 Treg cells/million cells
Interval 0.0001 to 0.261
|
|
Frequency of Cluster of Differentiation 4 (CD4) + Forkhead Box p3 (Foxp3) + Expressing CD45RA and/or Human Leucocyte Antigen DR Complex (HLA-DR) and/or Inducible T Cell Co-stimulator (ICOS) and/or PD1
CD4+FOXP3+CD45RA+HLADR+ICOS-PD1+
|
0.1191 Treg cells/million cells
Interval 0.0001 to 0.2565
|
0.119 Treg cells/million cells
Interval 0.0747 to 0.134
|
0.0762 Treg cells/million cells
Interval 0.03 to 0.189
|
0.0885 Treg cells/million cells
Interval 0.0001 to 0.158
|
|
Frequency of Cluster of Differentiation 4 (CD4) + Forkhead Box p3 (Foxp3) + Expressing CD45RA and/or Human Leucocyte Antigen DR Complex (HLA-DR) and/or Inducible T Cell Co-stimulator (ICOS) and/or PD1
CD4+FOXP3+CD45RA+HLADR+ICOS-PD1-
|
0.9705 Treg cells/million cells
Interval 0.1534 to 1.95
|
0.2905 Treg cells/million cells
Interval 0.21 to 0.528
|
0.51 Treg cells/million cells
Interval 0.232 to 0.902
|
0.388 Treg cells/million cells
Interval 0.09 to 0.567
|
|
Frequency of Cluster of Differentiation 4 (CD4) + Forkhead Box p3 (Foxp3) + Expressing CD45RA and/or Human Leucocyte Antigen DR Complex (HLA-DR) and/or Inducible T Cell Co-stimulator (ICOS) and/or PD1
CD4+FOXP3+CD45RA+HLADR-ICOS+PD1+
|
0.1836 Treg cells/million cells
Interval 0.0001 to 0.4805
|
0.0637 Treg cells/million cells
Interval 0.0001 to 0.112
|
0.106 Treg cells/million cells
Interval 0.0339 to 0.227
|
0.092 Treg cells/million cells
Interval 0.0675 to 0.3
|
|
Frequency of Cluster of Differentiation 4 (CD4) + Forkhead Box p3 (Foxp3) + Expressing CD45RA and/or Human Leucocyte Antigen DR Complex (HLA-DR) and/or Inducible T Cell Co-stimulator (ICOS) and/or PD1
CD4+FOXP3+CD45RA+HLADR-ICOS+PD1-
|
0.3915 Treg cells/million cells
Interval 0.1665 to 0.9885
|
0.356 Treg cells/million cells
Interval 0.0747 to 0.725
|
0.74 Treg cells/million cells
Interval 0.244 to 1.43
|
0.3185 Treg cells/million cells
Interval 0.151 to 0.68
|
|
Frequency of Cluster of Differentiation 4 (CD4) + Forkhead Box p3 (Foxp3) + Expressing CD45RA and/or Human Leucocyte Antigen DR Complex (HLA-DR) and/or Inducible T Cell Co-stimulator (ICOS) and/or PD1
CD4+FOXP3+CD45RA+HLADR-ICOS-PD1+
|
0.0723 Treg cells/million cells
Interval 0.0327 to 0.1541
|
0.1245 Treg cells/million cells
Interval 0.0001 to 0.18
|
0.0972 Treg cells/million cells
Interval 0.0001 to 0.182
|
0.138 Treg cells/million cells
Interval 0.07 to 0.358
|
|
Frequency of Cluster of Differentiation 4 (CD4) + Forkhead Box p3 (Foxp3) + Expressing CD45RA and/or Human Leucocyte Antigen DR Complex (HLA-DR) and/or Inducible T Cell Co-stimulator (ICOS) and/or PD1
CD4+FOXP3+CD45RA+HLADR-ICOS-PD1-
|
14.8 Treg cells/million cells
Interval 7.605 to 23.3
|
14.2 Treg cells/million cells
Interval 8.82 to 27.9
|
15.985 Treg cells/million cells
Interval 12.7 to 24.85
|
14.6 Treg cells/million cells
Interval 9.04 to 21.7
|
|
Frequency of Cluster of Differentiation 4 (CD4) + Forkhead Box p3 (Foxp3) + Expressing CD45RA and/or Human Leucocyte Antigen DR Complex (HLA-DR) and/or Inducible T Cell Co-stimulator (ICOS) and/or PD1
CD4+FOXP3+CD45RA-HLADR+ICOS+PD1+
|
0.629 Treg cells/million cells
Interval 0.1209 to 1.27
|
2.48 Treg cells/million cells
Interval 1.21 to 3.42
|
1.85 Treg cells/million cells
Interval 0.937 to 2.93
|
2.03 Treg cells/million cells
Interval 1.22 to 4.61
|
|
Frequency of Cluster of Differentiation 4 (CD4) + Forkhead Box p3 (Foxp3) + Expressing CD45RA and/or Human Leucocyte Antigen DR Complex (HLA-DR) and/or Inducible T Cell Co-stimulator (ICOS) and/or PD1
CD4+FOXP3+CD45RA-HLADR+ICOS+PD1-
|
18.8 Treg cells/million cells
Interval 7.58 to 27.7
|
13.35 Treg cells/million cells
Interval 9.41 to 20.7
|
17.15 Treg cells/million cells
Interval 11.15 to 24.0
|
14.86 Treg cells/million cells
Interval 9.81 to 19.4
|
|
Frequency of Cluster of Differentiation 4 (CD4) + Forkhead Box p3 (Foxp3) + Expressing CD45RA and/or Human Leucocyte Antigen DR Complex (HLA-DR) and/or Inducible T Cell Co-stimulator (ICOS) and/or PD1
CD4+FOXP3+CD45RA-HLADR+ICOS-PD1+
|
0.5645 Treg cells/million cells
Interval 0.0596 to 2.92
|
0.478 Treg cells/million cells
Interval 0.234 to 1.57
|
0.651 Treg cells/million cells
Interval 0.177 to 0.944
|
1.03 Treg cells/million cells
Interval 0.49 to 2.64
|
|
Frequency of Cluster of Differentiation 4 (CD4) + Forkhead Box p3 (Foxp3) + Expressing CD45RA and/or Human Leucocyte Antigen DR Complex (HLA-DR) and/or Inducible T Cell Co-stimulator (ICOS) and/or PD1
CD4+FOXP3+CD45RA-HLADR+ICOS-PD1-
|
18.7 Treg cells/million cells
Interval 7.21 to 29.4
|
5.065 Treg cells/million cells
Interval 3.31 to 10.4
|
7.16 Treg cells/million cells
Interval 4.72 to 12.7
|
11.6 Treg cells/million cells
Interval 4.37 to 23.04
|
|
Frequency of Cluster of Differentiation 4 (CD4) + Forkhead Box p3 (Foxp3) + Expressing CD45RA and/or Human Leucocyte Antigen DR Complex (HLA-DR) and/or Inducible T Cell Co-stimulator (ICOS) and/or PD1
CD4+FOXP3+CD45RA-HLADR-ICOS+PD1+
|
0.6269 Treg cells/million cells
Interval 0.0815 to 1.82
|
1.285 Treg cells/million cells
Interval 0.844 to 2.17
|
1.26 Treg cells/million cells
Interval 0.8 to 2.14
|
1.96 Treg cells/million cells
Interval 0.859 to 3.43
|
|
Frequency of Cluster of Differentiation 4 (CD4) + Forkhead Box p3 (Foxp3) + Expressing CD45RA and/or Human Leucocyte Antigen DR Complex (HLA-DR) and/or Inducible T Cell Co-stimulator (ICOS) and/or PD1
CD4+FOXP3+CD45RA-HLADR-ICOS+PD1-
|
6.39 Treg cells/million cells
Interval 3.48 to 8.345
|
9.66 Treg cells/million cells
Interval 4.71 to 22.1
|
10.57 Treg cells/million cells
Interval 5.955 to 16.035
|
9.79 Treg cells/million cells
Interval 6.84 to 14.4
|
|
Frequency of Cluster of Differentiation 4 (CD4) + Forkhead Box p3 (Foxp3) + Expressing CD45RA and/or Human Leucocyte Antigen DR Complex (HLA-DR) and/or Inducible T Cell Co-stimulator (ICOS) and/or PD1
CD4+FOXP3+CD45RA-HLADR-ICOS-PD1+
|
0.7075 Treg cells/million cells
Interval 0.2181 to 6.6895
|
2.07 Treg cells/million cells
Interval 1.43 to 3.45
|
1.815 Treg cells/million cells
Interval 0.51 to 2.88
|
3.28 Treg cells/million cells
Interval 1.77 to 4.67
|
|
Frequency of Cluster of Differentiation 4 (CD4) + Forkhead Box p3 (Foxp3) + Expressing CD45RA and/or Human Leucocyte Antigen DR Complex (HLA-DR) and/or Inducible T Cell Co-stimulator (ICOS) and/or PD1
CD4+FOXP3+CD45RA-HLADR-ICOS-PD1-
|
27.85 Treg cells/million cells
Interval 21.35 to 44.5
|
36.8 Treg cells/million cells
Interval 23.5 to 41.9
|
29.85 Treg cells/million cells
Interval 24.065 to 38.4
|
33.2 Treg cells/million cells
Interval 22.1 to 36.4
|
|
Frequency of Cluster of Differentiation 4 (CD4) + Forkhead Box p3 (Foxp3) + Expressing CD45RA and/or Human Leucocyte Antigen DR Complex (HLA-DR) and/or Inducible T Cell Co-stimulator (ICOS) and/or PD1
CD4+FOXP3+HLADR+
|
45.4 Treg cells/million cells
Interval 25.025 to 56.0
|
25.75 Treg cells/million cells
Interval 20.5 to 35.5
|
31.65 Treg cells/million cells
Interval 24.1 to 40.0
|
36.6 Treg cells/million cells
Interval 19.5 to 47.94
|
|
Frequency of Cluster of Differentiation 4 (CD4) + Forkhead Box p3 (Foxp3) + Expressing CD45RA and/or Human Leucocyte Antigen DR Complex (HLA-DR) and/or Inducible T Cell Co-stimulator (ICOS) and/or PD1
CD4+FOXP3+ICOS+
|
28 Treg cells/million cells
Interval 16.35 to 38.1
|
41.1 Treg cells/million cells
Interval 18.0 to 51.5
|
33.795 Treg cells/million cells
Interval 21.6 to 48.5
|
35.3 Treg cells/million cells
Interval 24.3 to 38.67
|
|
Frequency of Cluster of Differentiation 4 (CD4) + Forkhead Box p3 (Foxp3) + Expressing CD45RA and/or Human Leucocyte Antigen DR Complex (HLA-DR) and/or Inducible T Cell Co-stimulator (ICOS) and/or PD1
CD4+FOXP3+PD1+
|
5.505 Treg cells/million cells
Interval 1.3975 to 13.225
|
8.465 Treg cells/million cells
Interval 7.04 to 12.0
|
6.98 Treg cells/million cells
Interval 3.57 to 10.45
|
9.61 Treg cells/million cells
Interval 7.08 to 17.1
|
|
Frequency of Cluster of Differentiation 4 (CD4) + Forkhead Box p3 (Foxp3) + Expressing CD45RA and/or Human Leucocyte Antigen DR Complex (HLA-DR) and/or Inducible T Cell Co-stimulator (ICOS) and/or PD1
CD4+polypositives FOXP3+CD45RA+HLADR+ICOS+PD1
|
0.1167 Treg cells/million cells
Interval 0.0556 to 0.46
|
0.209 Treg cells/million cells
Interval 0.0804 to 0.36
|
0.1645 Treg cells/million cells
Interval 0.0894 to 0.25
|
0.1935 Treg cells/million cells
Interval 0.0675 to 0.5
|
PRIMARY outcome
Timeframe: At the time of the visit for each subject (i.e., Day 0)Population: The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.
The frequency was assessed based on the following range of markers: CD4, CD45RA, ICOS, HLA-DR, PD-1 and anti-Foxp3.
Outcome measures
| Measure |
Immune Tolerant Patients Group
n=4 Participants
Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
|
HBeAg Positive Group
n=10 Participants
HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
|
Inactive Carriers Group
n=56 Participants
Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
|
HBeAg Negative Group
n=19 Participants
HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
|
|---|---|---|---|---|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or HLADR and/or ICOS and/or PD1
CD4+FOXP3-PD1+
|
14.6 Treg cells/million cells
Interval 10.565 to 18.0
|
9.895 Treg cells/million cells
Interval 9.12 to 21.0
|
14.17 Treg cells/million cells
Interval 8.025 to 40.88
|
20.3 Treg cells/million cells
Interval 13.9 to 59.51
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or HLADR and/or ICOS and/or PD1
CD4+polypositives FOXP3-CD45RA+HLADR+ICOS+PD1
|
0.0998 Treg cells/million cells
Interval 0.0562 to 0.1525
|
0.069 Treg cells/million cells
Interval 0.0394 to 0.148
|
0.0689 Treg cells/million cells
Interval 0.0377 to 0.2355
|
0.0431 Treg cells/million cells
Interval 0.028 to 0.124
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or HLADR and/or ICOS and/or PD1
CD4+FOXP3-
|
94.95 Treg cells/million cells
Interval 94.7 to 95.45
|
93.75 Treg cells/million cells
Interval 93.6 to 94.9
|
95.88 Treg cells/million cells
Interval 93.8 to 96.61
|
95 Treg cells/million cells
Interval 93.8 to 96.0
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or HLADR and/or ICOS and/or PD1
CD4+FOXP3-CD45RA+
|
38.7 Treg cells/million cells
Interval 23.69 to 41.75
|
44.3 Treg cells/million cells
Interval 36.6 to 57.7
|
33.9 Treg cells/million cells
Interval 22.13 to 41.6
|
30.2 Treg cells/million cells
Interval 16.47 to 41.07
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or HLADR and/or ICOS and/or PD1
CD4+FOXP3-CD45RA+HLADR+ICOS+PD1-
|
0.0995 Treg cells/million cells
Interval 0.046 to 0.2155
|
0.1103 Treg cells/million cells
Interval 0.0519 to 0.167
|
0.0853 Treg cells/million cells
Interval 0.0346 to 0.1865
|
0.0297 Treg cells/million cells
Interval 0.004 to 0.115
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or HLADR and/or ICOS and/or PD1
CD4+FOXP3-CD45RA+HLADR+ICOS-PD1+
|
0.2825 Treg cells/million cells
Interval 0.127 to 0.4995
|
0.1695 Treg cells/million cells
Interval 0.123 to 0.369
|
0.267 Treg cells/million cells
Interval 0.109 to 0.983
|
0.232 Treg cells/million cells
Interval 0.147 to 0.857
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or HLADR and/or ICOS and/or PD1
CD4+FOXP3-CD45RA+HLADR+ICOS-PD1-
|
1.53 Treg cells/million cells
Interval 0.7938 to 1.68
|
1.52 Treg cells/million cells
Interval 0.951 to 3.3
|
1.71 Treg cells/million cells
Interval 0.406 to 2.805
|
1.07 Treg cells/million cells
Interval 0.424 to 1.89
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or HLADR and/or ICOS and/or PD1
CD4+FOXP3-CD45RA+HLADR-ICOS+PD1+
|
0.0895 Treg cells/million cells
Interval 0.0265 to 0.346
|
0.0928 Treg cells/million cells
Interval 0.0569 to 0.141
|
0.0873 Treg cells/million cells
Interval 0.0413 to 0.3565
|
0.0976 Treg cells/million cells
Interval 0.0273 to 0.598
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or HLADR and/or ICOS and/or PD1
CD4+FOXP3-CD45RA+HLADR-ICOS+PD1-
|
1.33 Treg cells/million cells
Interval 0.6668 to 3.695
|
1.84 Treg cells/million cells
Interval 0.48 to 3.52
|
0.973 Treg cells/million cells
Interval 0.325 to 2.895
|
0.357 Treg cells/million cells
Interval 0.0525 to 0.957
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or HLADR and/or ICOS and/or PD1
CD4+FOXP3-CD45RA+HLADR-ICOS-PD1+
|
0.174 Treg cells/million cells
Interval 0.1254 to 0.3645
|
0.193 Treg cells/million cells
Interval 0.0875 to 1.15
|
0.2585 Treg cells/million cells
Interval 0.126 to 4.37
|
0.368 Treg cells/million cells
Interval 0.0837 to 12.58
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or HLADR and/or ICOS and/or PD1
CD4+FOXP3-CD45RA+HLADR-ICOS-PD1-
|
32.15 Treg cells/million cells
Interval 18.68 to 38.0
|
36.95 Treg cells/million cells
Interval 32.0 to 54.5
|
23.8 Treg cells/million cells
Interval 10.64 to 31.75
|
14.96 Treg cells/million cells
Interval 4.58 to 26.8
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or HLADR and/or ICOS and/or PD1
CD4+FOXP3-CD45RA-HLADR+ICOS+PD1+
|
1.37 Treg cells/million cells
Interval 0.8255 to 1.935
|
0.995 Treg cells/million cells
Interval 0.469 to 1.54
|
1.026 Treg cells/million cells
Interval 0.3795 to 1.835
|
0.994 Treg cells/million cells
Interval 0.549 to 1.96
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or HLADR and/or ICOS and/or PD1
CD4+FOXP3-CD45RA-HLADR+ICOS+PD1-
|
1.515 Treg cells/million cells
Interval 0.6425 to 2.11
|
0.727 Treg cells/million cells
Interval 0.567 to 0.903
|
0.789 Treg cells/million cells
Interval 0.352 to 1.51
|
0.522 Treg cells/million cells
Interval 0.01 to 1.48
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or HLADR and/or ICOS and/or PD1
CD4+FOXP3-CD45RA-HLADR+ICOS-PD1+
|
1.065 Treg cells/million cells
Interval 0.944 to 1.23
|
0.8265 Treg cells/million cells
Interval 0.59 to 1.28
|
0.8765 Treg cells/million cells
Interval 0.3965 to 2.0
|
1.34 Treg cells/million cells
Interval 0.837 to 2.51
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or HLADR and/or ICOS and/or PD1
CD4+FOXP3-CD45RA-HLADR+ICOS-PD1-
|
1.755 Treg cells/million cells
Interval 1.2135 to 2.83
|
0.979 Treg cells/million cells
Interval 0.571 to 1.52
|
1.32 Treg cells/million cells
Interval 0.591 to 2.805
|
0.989 Treg cells/million cells
Interval 0.07 to 4.27
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or HLADR and/or ICOS and/or PD1
CD4+FOXP3-CD45RA-HLADR-ICOS+PD1+
|
1.935 Treg cells/million cells
Interval 1.34 to 5.78
|
2.28 Treg cells/million cells
Interval 1.04 to 3.28
|
2.485 Treg cells/million cells
Interval 1.17 to 7.05
|
3.02 Treg cells/million cells
Interval 1.66 to 9.15
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or HLADR and/or ICOS and/or PD1
CD4+FOXP3-CD45RA-HLADR-ICOS+PD1-
|
7.985 Treg cells/million cells
Interval 4.65 to 13.555
|
8.835 Treg cells/million cells
Interval 3.38 to 12.0
|
7.965 Treg cells/million cells
Interval 4.25 to 14.0
|
5.95 Treg cells/million cells
Interval 0.11 to 9.55
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or HLADR and/or ICOS and/or PD1
CD4+FOXP3-CD45RA-HLADR-ICOS-PD1+
|
8.21 Treg cells/million cells
Interval 4.49 to 10.285
|
6.2 Treg cells/million cells
Interval 3.88 to 11.8
|
7.385 Treg cells/million cells
Interval 3.62 to 13.25
|
14.1 Treg cells/million cells
Interval 7.07 to 24.5
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or HLADR and/or ICOS and/or PD1
CD4+FOXP3-CD45RA-HLADR-ICOS-PD1-
|
35.6 Treg cells/million cells
Interval 27.95 to 54.7
|
27.95 Treg cells/million cells
Interval 23.4 to 40.8
|
34.8 Treg cells/million cells
Interval 19.6 to 43.425
|
37.7 Treg cells/million cells
Interval 16.8 to 52.6
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or HLADR and/or ICOS and/or PD1
CD4+FOXP3-HLADR+
|
7.845 Treg cells/million cells
Interval 5.62 to 9.685
|
6.22 Treg cells/million cells
Interval 4.4 to 7.11
|
8.66 Treg cells/million cells
Interval 5.26 to 10.95
|
7.65 Treg cells/million cells
Interval 5.92 to 11.9
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or HLADR and/or ICOS and/or PD1
CD4+FOXP3-ICOS+
|
14.6 Treg cells/million cells
Interval 8.77 to 27.3
|
16.95 Treg cells/million cells
Interval 11.1 to 18.5
|
21.03 Treg cells/million cells
Interval 8.915 to 32.525
|
12.2 Treg cells/million cells
Interval 8.85 to 21.34
|
PRIMARY outcome
Timeframe: At the time of the visit for each subject (i.e., Day 0)Population: The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.
The frequency was assessed based on the following range of markers: CD4, CD45RA, GITR, anti-Foxp3 and Ki67.
Outcome measures
| Measure |
Immune Tolerant Patients Group
n=4 Participants
Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
|
HBeAg Positive Group
n=11 Participants
HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
|
Inactive Carriers Group
n=55 Participants
Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
|
HBeAg Negative Group
n=20 Participants
HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
|
|---|---|---|---|---|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or Glucocorticoid-induced Tumor Necrosis Factor Receptor-related Protein (GITR) and/or Proliferation Marker Ki67
CD4+FOXP3+
|
5.335 Treg cells/million cells
Interval 3.875 to 7.105
|
5.82 Treg cells/million cells
Interval 5.62 to 6.8
|
4.68 Treg cells/million cells
Interval 3.77 to 5.97
|
5.37 Treg cells/million cells
Interval 4.18 to 6.24
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or Glucocorticoid-induced Tumor Necrosis Factor Receptor-related Protein (GITR) and/or Proliferation Marker Ki67
CD4+FOXP3+CD45RA+
|
12.85 Treg cells/million cells
Interval 11.2 to 22.2
|
14.8 Treg cells/million cells
Interval 5.9 to 32.8
|
18.2 Treg cells/million cells
Interval 13.6 to 27.34
|
16.5 Treg cells/million cells
Interval 8.58 to 29.3
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or Glucocorticoid-induced Tumor Necrosis Factor Receptor-related Protein (GITR) and/or Proliferation Marker Ki67
CD4+FOXP3+CD45RA+GITR+KI67-
|
0.2955 Treg cells/million cells
Interval 0.0861 to 1.1145
|
0.429 Treg cells/million cells
Interval 0.211 to 0.571
|
0.49 Treg cells/million cells
Interval 0.269 to 0.74
|
0.399 Treg cells/million cells
Interval 0.288 to 0.599
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or Glucocorticoid-induced Tumor Necrosis Factor Receptor-related Protein (GITR) and/or Proliferation Marker Ki67
CD4+FOXP3+CD45RA+GITR-KI67+
|
0.0985 Treg cells/million cells
Interval 0.0663 to 0.218
|
0.2085 Treg cells/million cells
Interval 0.12 to 0.564
|
0.234 Treg cells/million cells
Interval 0.14 to 0.448
|
0.267 Treg cells/million cells
Interval 0.07 to 0.452
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or Glucocorticoid-induced Tumor Necrosis Factor Receptor-related Protein (GITR) and/or Proliferation Marker Ki67
CD4+FOXP3+CD45RA+GITR-KI67-
|
12.55 Treg cells/million cells
Interval 10.75 to 20.55
|
13.8 Treg cells/million cells
Interval 3.9 to 29.9
|
17.7 Treg cells/million cells
Interval 13.1 to 25.7
|
15.4 Treg cells/million cells
Interval 7.34 to 27.93
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or Glucocorticoid-induced Tumor Necrosis Factor Receptor-related Protein (GITR) and/or Proliferation Marker Ki67
CD4+FOXP3+CD45RA-GITR+KI67+
|
9.26 Treg cells/million cells
Interval 7.055 to 11.05
|
8.24 Treg cells/million cells
Interval 4.47 to 10.4
|
8.14 Treg cells/million cells
Interval 6.32 to 11.32
|
7.43 Treg cells/million cells
Interval 5.09 to 9.56
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or Glucocorticoid-induced Tumor Necrosis Factor Receptor-related Protein (GITR) and/or Proliferation Marker Ki67
CD4+FOXP3+CD45RA-GITR+KI67-
|
35.65 Treg cells/million cells
Interval 26.5 to 43.5
|
33.4 Treg cells/million cells
Interval 21.6 to 45.2
|
27.34 Treg cells/million cells
Interval 22.3 to 34.18
|
28.8 Treg cells/million cells
Interval 20.0 to 36.63
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or Glucocorticoid-induced Tumor Necrosis Factor Receptor-related Protein (GITR) and/or Proliferation Marker Ki67
CD4+FOXP3+CD45RA-GITR-KI67+
|
4.84 Treg cells/million cells
Interval 3.44 to 7.11
|
3.66 Treg cells/million cells
Interval 2.58 to 5.58
|
4.69 Treg cells/million cells
Interval 3.88 to 6.77
|
4.27 Treg cells/million cells
Interval 3.67 to 6.19
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or Glucocorticoid-induced Tumor Necrosis Factor Receptor-related Protein (GITR) and/or Proliferation Marker Ki67
CD4+FOXP3+CD45RA-GITR-KI67-
|
30.9 Treg cells/million cells
Interval 22.6 to 45.3
|
32.3 Treg cells/million cells
Interval 24.4 to 36.7
|
37.1 Treg cells/million cells
Interval 28.1 to 42.6
|
41.4 Treg cells/million cells
Interval 36.0 to 47.0
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or Glucocorticoid-induced Tumor Necrosis Factor Receptor-related Protein (GITR) and/or Proliferation Marker Ki67
CD4+FOXP3+GITR+
|
46.4 Treg cells/million cells
Interval 34.95 to 55.0
|
49.1 Treg cells/million cells
Interval 26.5 to 57.4
|
38.5 Treg cells/million cells
Interval 30.51 to 46.0
|
36.9 Treg cells/million cells
Interval 25.6 to 45.6
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or Glucocorticoid-induced Tumor Necrosis Factor Receptor-related Protein (GITR) and/or Proliferation Marker Ki67
CD4+FOXP3+KI67+
|
13.95 Treg cells/million cells
Interval 12.25 to 17.25
|
14.2 Treg cells/million cells
Interval 8.14 to 15.7
|
13.8 Treg cells/million cells
Interval 10.89 to 18.9
|
12.7 Treg cells/million cells
Interval 9.49 to 16.5
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or Glucocorticoid-induced Tumor Necrosis Factor Receptor-related Protein (GITR) and/or Proliferation Marker Ki67
CD4+polypositives FOXP3+CD45RA+GITR+KI67
|
0.2685 Treg cells/million cells
Interval 0.1568 to 0.4415
|
0.1855 Treg cells/million cells
Interval 0.0945 to 0.42
|
0.331 Treg cells/million cells
Interval 0.14 to 0.53
|
0.28 Treg cells/million cells
Interval 0.175 to 0.512
|
PRIMARY outcome
Timeframe: At the time of the visit for each subject (i.e., Day 0)Population: The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.
The frequency was assessed based on the following range of markers: CD4, CD45RA, GITR, anti-Foxp3 and Ki67.
Outcome measures
| Measure |
Immune Tolerant Patients Group
n=4 Participants
Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
|
HBeAg Positive Group
n=11 Participants
HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
|
Inactive Carriers Group
n=55 Participants
Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
|
HBeAg Negative Group
n=20 Participants
HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
|
|---|---|---|---|---|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or GITR and/or Ki67
CD4+FOXP3-
|
94.65 Treg cells/million cells
Interval 92.85 to 96.15
|
94.2 Treg cells/million cells
Interval 93.3 to 94.4
|
95.31 Treg cells/million cells
Interval 94.0 to 96.2
|
94.65 Treg cells/million cells
Interval 93.75 to 95.85
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or GITR and/or Ki67
CD4+FOXP3-CD45RA+
|
45.95 Treg cells/million cells
Interval 42.8 to 49.25
|
42.9 Treg cells/million cells
Interval 29.4 to 56.5
|
34.3 Treg cells/million cells
Interval 26.7 to 44.3
|
33.4 Treg cells/million cells
Interval 24.295 to 43.4
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or GITR and/or Ki67
CD4+FOXP3-CD45RA+GITR+KI67-
|
0.6515 Treg cells/million cells
Interval 0.4665 to 5.7485
|
0.567 Treg cells/million cells
Interval 0.359 to 0.891
|
0.609 Treg cells/million cells
Interval 0.27 to 2.23
|
0.563 Treg cells/million cells
Interval 0.3155 to 1.46
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or GITR and/or Ki67
CD4+FOXP3-CD45RA+GITR-KI67+
|
0.328 Treg cells/million cells
Interval 0.226 to 0.393
|
0.365 Treg cells/million cells
Interval 0.332 to 0.685
|
0.251 Treg cells/million cells
Interval 0.142 to 0.404
|
0.2275 Treg cells/million cells
Interval 0.166 to 0.471
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or GITR and/or Ki67
CD4+FOXP3-CD45RA+GITR-KI67-
|
42.85 Treg cells/million cells
Interval 36.6 to 48.25
|
42.5 Treg cells/million cells
Interval 27.8 to 55.2
|
30.14 Treg cells/million cells
Interval 14.15 to 41.1
|
30.3 Treg cells/million cells
Interval 19.95 to 37.9
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or GITR and/or Ki67
CD4+FOXP3-CD45RA-GITR+KI67+
|
1.0535 Treg cells/million cells
Interval 0.583 to 1.38
|
0.566 Treg cells/million cells
Interval 0.472 to 0.974
|
0.854 Treg cells/million cells
Interval 0.528 to 1.46
|
0.7955 Treg cells/million cells
Interval 0.5645 to 1.27
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or GITR and/or Ki67
CD4+FOXP3-CD45RA-GITR+KI67-
|
13.35 Treg cells/million cells
Interval 8.36 to 19.25
|
12.6 Treg cells/million cells
Interval 4.34 to 15.6
|
12.94 Treg cells/million cells
Interval 7.33 to 16.51
|
13.225 Treg cells/million cells
Interval 9.03 to 14.95
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or GITR and/or Ki67
CD4+FOXP3-CD45RA-GITR-KI67+
|
1.575 Treg cells/million cells
Interval 1.405 to 2.05
|
1.56 Treg cells/million cells
Interval 1.25 to 2.44
|
1.83 Treg cells/million cells
Interval 1.29 to 2.24
|
1.455 Treg cells/million cells
Interval 1.053 to 2.175
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or GITR and/or Ki67
CD4+FOXP3-CD45RA-GITR-KI67-
|
37.5 Treg cells/million cells
Interval 29.1 to 45.8
|
43.7 Treg cells/million cells
Interval 34.3 to 52.6
|
49.1 Treg cells/million cells
Interval 40.7 to 58.5
|
50.9 Treg cells/million cells
Interval 38.55 to 59.655
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or GITR and/or Ki67
CD4+FOXP3-GITR+
|
15.05 Treg cells/million cells
Interval 9.585 to 26.7
|
14 Treg cells/million cells
Interval 5.88 to 17.1
|
15.9 Treg cells/million cells
Interval 8.49 to 19.72
|
15.7 Treg cells/million cells
Interval 10.155 to 17.65
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or GITR and/or Ki67
CD4+FOXP3-KI67+
|
3.18 Treg cells/million cells
Interval 2.47 to 3.98
|
3.42 Treg cells/million cells
Interval 2.32 to 4.0
|
3.32 Treg cells/million cells
Interval 2.43 to 4.57
|
3.28 Treg cells/million cells
Interval 2.06 to 3.76
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or GITR and/or Ki67
CD4+polypositives FOXP3-CD45RA+GITR+KI67
|
0.1275 Treg cells/million cells
Interval 0.0874 to 0.331
|
0.0944 Treg cells/million cells
Interval 0.081 to 0.162
|
0.0945 Treg cells/million cells
Interval 0.049 to 0.202
|
0.0901 Treg cells/million cells
Interval 0.0717 to 0.14
|
PRIMARY outcome
Timeframe: At the time of the visit for each subject (i.e., Day 0)Population: The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.
The frequency was assessed based on the following range of markers: CD4, CD45RA, CCR7, CD62L and anti-Foxp3.
Outcome measures
| Measure |
Immune Tolerant Patients Group
n=4 Participants
Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
|
HBeAg Positive Group
n=11 Participants
HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
|
Inactive Carriers Group
n=57 Participants
Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
|
HBeAg Negative Group
n=19 Participants
HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
|
|---|---|---|---|---|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or, Chemokine (C-C Motif) Receptor 7 (CCR7) and/or CD62L
CD4+FOXP3+
|
4.12 Treg cells/million cells
Interval 3.33 to 5.14
|
5.48 Treg cells/million cells
Interval 4.56 to 6.07
|
4.26 Treg cells/million cells
Interval 3.19 to 6.0
|
4.64 Treg cells/million cells
Interval 2.87 to 5.22
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or, Chemokine (C-C Motif) Receptor 7 (CCR7) and/or CD62L
CD4+FOXP3+CCR7+
|
44.15 Treg cells/million cells
Interval 38.45 to 50.9
|
48.4 Treg cells/million cells
Interval 35.1 to 61.1
|
54.065 Treg cells/million cells
Interval 43.54 to 59.75
|
42.4 Treg cells/million cells
Interval 29.9 to 55.9
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or, Chemokine (C-C Motif) Receptor 7 (CCR7) and/or CD62L
CD4+FOXP3+CCR7+CD45RA+CD62L-
|
0.4295 Treg cells/million cells
Interval 0.1971 to 0.515
|
0.2005 Treg cells/million cells
Interval 0.0747 to 0.366
|
0.11 Treg cells/million cells
Interval 0.0485 to 0.307
|
0.105 Treg cells/million cells
Interval 0.0676 to 0.364
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or, Chemokine (C-C Motif) Receptor 7 (CCR7) and/or CD62L
CD4+FOXP3+CCR7+CD45RA-CD62L+
|
27.85 Treg cells/million cells
Interval 21.45 to 33.35
|
30.1 Treg cells/million cells
Interval 22.6 to 32.6
|
34.66 Treg cells/million cells
Interval 27.24 to 39.24
|
25.65 Treg cells/million cells
Interval 21.4 to 31.7
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or, Chemokine (C-C Motif) Receptor 7 (CCR7) and/or CD62L
CD4+FOXP3+CCR7+CD45RA-CD62L-
|
1.73 Treg cells/million cells
Interval 1.027 to 3.11
|
3.4 Treg cells/million cells
Interval 1.56 to 4.86
|
1.88 Treg cells/million cells
Interval 1.18 to 2.83
|
2.065 Treg cells/million cells
Interval 1.63 to 2.76
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or, Chemokine (C-C Motif) Receptor 7 (CCR7) and/or CD62L
CD4+FOXP3+CCR7-CD45RA+CD62L+
|
0.909 Treg cells/million cells
Interval 0.2809 to 2.32
|
0.522 Treg cells/million cells
Interval 0.224 to 2.14
|
0.59 Treg cells/million cells
Interval 0.315 to 1.13
|
0.8925 Treg cells/million cells
Interval 0.36 to 1.94
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or, Chemokine (C-C Motif) Receptor 7 (CCR7) and/or CD62L
CD4+FOXP3+CCR7-CD45RA+CD62L-
|
0.0502 Treg cells/million cells
Interval 0.022 to 0.0671
|
0.0732 Treg cells/million cells
Interval 0.0249 to 0.142
|
0.0499 Treg cells/million cells
Interval 0.0001 to 0.0805
|
0.075 Treg cells/million cells
Interval 0.0277 to 0.14
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or, Chemokine (C-C Motif) Receptor 7 (CCR7) and/or CD62L
CD4+FOXP3+CCR7-CD45RA-CD62L+
|
43.3 Treg cells/million cells
Interval 34.85 to 51.85
|
36.6 Treg cells/million cells
Interval 31.7 to 43.5
|
37.7 Treg cells/million cells
Interval 32.9 to 44.35
|
42.5 Treg cells/million cells
Interval 32.6 to 56.08
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or, Chemokine (C-C Motif) Receptor 7 (CCR7) and/or CD62L
CD4+FOXP3+CCR7-CD45RA-CD62L-
|
9.6 Treg cells/million cells
Interval 7.19 to 13.9
|
13.2 Treg cells/million cells
Interval 6.19 to 16.8
|
6.56 Treg cells/million cells
Interval 4.805 to 10.06
|
8.985 Treg cells/million cells
Interval 6.93 to 15.9
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or, Chemokine (C-C Motif) Receptor 7 (CCR7) and/or CD62L
CD4+FOXP3+CD45RA+
|
14.8 Treg cells/million cells
Interval 13.5 to 19.65
|
14 Treg cells/million cells
Interval 8.64 to 31.2
|
16.95 Treg cells/million cells
Interval 11.8 to 23.0
|
14.25 Treg cells/million cells
Interval 8.43 to 19.48
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or, Chemokine (C-C Motif) Receptor 7 (CCR7) and/or CD62L
CD4+FOXP3+CD62L+
|
88.55 Treg cells/million cells
Interval 82.7 to 91.05
|
81.5 Treg cells/million cells
Interval 77.7 to 92.2
|
90.85 Treg cells/million cells
Interval 87.005 to 93.45
|
88.2 Treg cells/million cells
Interval 78.3 to 91.2
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or, Chemokine (C-C Motif) Receptor 7 (CCR7) and/or CD62L
CD4+polypositives FOXP3+CCR7+CD45RA+CD62L
|
14.25 Treg cells/million cells
Interval 11.295 to 18.4
|
11.3 Treg cells/million cells
Interval 5.76 to 28.6
|
15.1 Treg cells/million cells
Interval 11.25 to 21.4
|
11.95 Treg cells/million cells
Interval 6.42 to 15.28
|
PRIMARY outcome
Timeframe: At the time of the visit for each subject (i.e., Day 0)Population: The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.
The frequency was assessed based on the following range of markers: CD4, CD45RA, CCR7, CD62L and anti-Foxp3.
Outcome measures
| Measure |
Immune Tolerant Patients Group
n=4 Participants
Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
|
HBeAg Positive Group
n=11 Participants
HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
|
Inactive Carriers Group
n=57 Participants
Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
|
HBeAg Negative Group
n=19 Participants
HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
|
|---|---|---|---|---|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or CCR7 and/or CD62L
CD4+FOXP3-
|
95.9 Treg cells/million cells
Interval 94.85 to 96.7
|
94.4 Treg cells/million cells
Interval 93.9 to 95.4
|
95.73 Treg cells/million cells
Interval 94.0 to 96.8
|
95.4 Treg cells/million cells
Interval 94.8 to 97.1
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or CCR7 and/or CD62L
CD4+FOXP3-CCR7+
|
83.2 Treg cells/million cells
Interval 75.3 to 84.1
|
79.5 Treg cells/million cells
Interval 69.4 to 91.6
|
76.1 Treg cells/million cells
Interval 67.8 to 83.2
|
70.8 Treg cells/million cells
Interval 56.8 to 82.1
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or CCR7 and/or CD62L
CD4+FOXP3-CCR7+CD45RA+CD62L-
|
0.4295 Treg cells/million cells
Interval 0.1966 to 0.6885
|
0.474 Treg cells/million cells
Interval 0.259 to 0.664
|
0.305 Treg cells/million cells
Interval 0.187 to 0.58
|
0.272 Treg cells/million cells
Interval 0.196 to 1.03
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or CCR7 and/or CD62L
CD4+FOXP3-CCR7+CD45RA-CD62L+
|
32.2 Treg cells/million cells
Interval 25.45 to 38.3
|
26.7 Treg cells/million cells
Interval 24.5 to 31.7
|
34.7 Treg cells/million cells
Interval 26.7 to 40.32
|
33.4 Treg cells/million cells
Interval 22.7 to 36.04
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or CCR7 and/or CD62L
CD4+FOXP3-CCR7+CD45RA-CD62L-
|
5.79 Treg cells/million cells
Interval 3.915 to 7.415
|
4.09 Treg cells/million cells
Interval 2.86 to 5.84
|
4.35 Treg cells/million cells
Interval 2.5 to 6.33
|
5.16 Treg cells/million cells
Interval 2.4 to 8.58
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or CCR7 and/or CD62L
CD4+FOXP3-CCR7-CD45RA+CD62L+
|
1.005 Treg cells/million cells
Interval 0.388 to 1.485
|
0.755 Treg cells/million cells
Interval 0.259 to 2.1
|
0.719 Treg cells/million cells
Interval 0.469 to 2.36
|
1.01 Treg cells/million cells
Interval 0.415 to 2.12
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or CCR7 and/or CD62L
CD4+FOXP3-CCR7-CD45RA+CD62L-
|
1.2035 Treg cells/million cells
Interval 0.594 to 2.06
|
1.72 Treg cells/million cells
Interval 0.688 to 2.08
|
0.82 Treg cells/million cells
Interval 0.466 to 1.88
|
0.855 Treg cells/million cells
Interval 0.34 to 1.22
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or CCR7 and/or CD62L
CD4+FOXP3-CCR7-CD45RA-CD62L+
|
7.91 Treg cells/million cells
Interval 7.115 to 11.19
|
6.69 Treg cells/million cells
Interval 3.54 to 9.01
|
8.86 Treg cells/million cells
Interval 7.11 to 12.22
|
10.84 Treg cells/million cells
Interval 5.57 to 16.0
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or CCR7 and/or CD62L
CD4+FOXP3-CCR7-CD45RA-CD62L-
|
7.795 Treg cells/million cells
Interval 6.36 to 11.38
|
9.79 Treg cells/million cells
Interval 5.37 to 14.7
|
10.54 Treg cells/million cells
Interval 7.72 to 15.7
|
15.5 Treg cells/million cells
Interval 6.36 to 18.6
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or CCR7 and/or CD62L
CD4+FOXP3-CD45RA+
|
47.45 Treg cells/million cells
Interval 39.4 to 49.5
|
47.2 Treg cells/million cells
Interval 40.3 to 49.7
|
38.6 Treg cells/million cells
Interval 30.79 to 48.05
|
33.8 Treg cells/million cells
Interval 28.3 to 46.92
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or CCR7 and/or CD62L
CD4+FOXP3-CD62L+
|
83.6 Treg cells/million cells
Interval 81.4 to 85.95
|
85 Treg cells/million cells
Interval 77.1 to 88.7
|
83.6 Treg cells/million cells
Interval 76.4 to 86.3
|
75.3 Treg cells/million cells
Interval 72.0 to 86.0
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or CCR7 and/or CD62L
CD4+polypositives FOXP3-CCR7+CD45RA+CD62L
|
44.45 Treg cells/million cells
Interval 37.85 to 45.65
|
39.7 Treg cells/million cells
Interval 23.4 to 48.2
|
35.56 Treg cells/million cells
Interval 26.4 to 43.2
|
32.1 Treg cells/million cells
Interval 21.6 to 41.29
|
PRIMARY outcome
Timeframe: At the time of the visit for each subject (i.e., Day 0)Population: The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.
The frequency was assessed based on the following range of markers: CD4, CD45RA, CD39, TNFR2 and anti-Foxp3.
Outcome measures
| Measure |
Immune Tolerant Patients Group
n=4 Participants
Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
|
HBeAg Positive Group
n=11 Participants
HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
|
Inactive Carriers Group
n=56 Participants
Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
|
HBeAg Negative Group
n=19 Participants
HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
|
|---|---|---|---|---|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or CD39 and/or Tumor Necrosis Factor Receptor 2 (TNFR2)
CD4+FOXP3+
|
5.375 Treg cells/million cells
Interval 3.745 to 6.185
|
5.68 Treg cells/million cells
Interval 4.84 to 6.32
|
4.415 Treg cells/million cells
Interval 3.195 to 5.995
|
5.32 Treg cells/million cells
Interval 3.98 to 6.85
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or CD39 and/or Tumor Necrosis Factor Receptor 2 (TNFR2)
CD4+FOXP3+CD39+
|
47.25 Treg cells/million cells
Interval 28.4 to 52.3
|
54.7 Treg cells/million cells
Interval 24.1 to 65.5
|
42.2 Treg cells/million cells
Interval 15.2 to 54.8
|
46.9 Treg cells/million cells
Interval 32.9 to 63.79
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or CD39 and/or Tumor Necrosis Factor Receptor 2 (TNFR2)
CD4+FOXP3+CD39+CD45RA+TNFR2-
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0161
|
0.0156 Treg cells/million cells
Interval 0.0001 to 0.112
|
0.0381 Treg cells/million cells
Interval 0.0001 to 0.0706
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0512
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or CD39 and/or Tumor Necrosis Factor Receptor 2 (TNFR2)
CD4+FOXP3+CD39+CD45RA-TNFR2+
|
45.55 Treg cells/million cells
Interval 27.75 to 49.65
|
37.3 Treg cells/million cells
Interval 23.6 to 63.8
|
39.85 Treg cells/million cells
Interval 14.8 to 50.49
|
43.3 Treg cells/million cells
Interval 31.3 to 61.6
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or CD39 and/or Tumor Necrosis Factor Receptor 2 (TNFR2)
CD4+FOXP3+CD39+CD45RA-TNFR2-
|
0.48 Treg cells/million cells
Interval 0.133 to 0.831
|
0.165 Treg cells/million cells
Interval 0.12 to 0.352
|
0.1915 Treg cells/million cells
Interval 0.0977 to 0.6025
|
0.32 Treg cells/million cells
Interval 0.155 to 0.502
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or CD39 and/or Tumor Necrosis Factor Receptor 2 (TNFR2)
CD4+FOXP3+CD39-CD45RA+TNFR2+
|
14.8 Treg cells/million cells
Interval 11.47 to 17.45
|
11 Treg cells/million cells
Interval 8.25 to 24.8
|
17.075 Treg cells/million cells
Interval 12.6 to 21.3
|
13.12 Treg cells/million cells
Interval 6.96 to 18.0
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or CD39 and/or Tumor Necrosis Factor Receptor 2 (TNFR2)
CD4+FOXP3+CD39-CD45RA+TNFR2-
|
1.009 Treg cells/million cells
Interval 0.5365 to 1.325
|
0.7245 Treg cells/million cells
Interval 0.497 to 1.16
|
0.815 Treg cells/million cells
Interval 0.48 to 1.79
|
0.658 Treg cells/million cells
Interval 0.155 to 1.81
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or CD39 and/or Tumor Necrosis Factor Receptor 2 (TNFR2)
CD4+FOXP3+CD39-CD45RA-TNFR2+
|
35.25 Treg cells/million cells
Interval 30.15 to 56.35
|
25.4 Treg cells/million cells
Interval 21.9 to 45.3
|
37.685 Treg cells/million cells
Interval 28.4 to 56.7
|
32.01 Treg cells/million cells
Interval 24.4 to 49.0
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or CD39 and/or Tumor Necrosis Factor Receptor 2 (TNFR2)
CD4+FOXP3+CD39-CD45RA-TNFR2-
|
0.8705 Treg cells/million cells
Interval 0.7215 to 1.256
|
0.6765 Treg cells/million cells
Interval 0.448 to 0.776
|
1.085 Treg cells/million cells
Interval 0.628 to 2.16
|
0.702 Treg cells/million cells
Interval 0.4 to 1.84
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or CD39 and/or Tumor Necrosis Factor Receptor 2 (TNFR2)
CD4+FOXP3+CD45RA+
|
17 Treg cells/million cells
Interval 13.1 to 20.05
|
13.4 Treg cells/million cells
Interval 9.32 to 39.3
|
19.75 Treg cells/million cells
Interval 15.8 to 24.5
|
15.7 Treg cells/million cells
Interval 8.08 to 21.6
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or CD39 and/or Tumor Necrosis Factor Receptor 2 (TNFR2)
CD4+FOXP3+TNFR2+
|
97.7 Treg cells/million cells
Interval 97.15 to 98.0
|
98.4 Treg cells/million cells
Interval 98.0 to 98.6
|
97.25 Treg cells/million cells
Interval 95.7 to 98.6
|
97.9 Treg cells/million cells
Interval 96.2 to 98.9
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or CD39 and/or Tumor Necrosis Factor Receptor 2 (TNFR2)
CD4+pol FOXP3+CD39+CD45RA+TNFR2
|
1.2415 Treg cells/million cells
Interval 0.509 to 1.805
|
1.49 Treg cells/million cells
Interval 1.09 to 2.25
|
1.215 Treg cells/million cells
Interval 0.47 to 2.03
|
0.9295 Treg cells/million cells
Interval 0.593 to 1.35
|
PRIMARY outcome
Timeframe: At the time of the visit for each subject (i.e., Day 0)Population: The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.
The frequency was assessed based on the following range of markers: CD4, CD45RA, CD39, TNFR2 and anti-Foxp3.
Outcome measures
| Measure |
Immune Tolerant Patients Group
n=4 Participants
Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
|
HBeAg Positive Group
n=11 Participants
HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
|
Inactive Carriers Group
n=56 Participants
Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
|
HBeAg Negative Group
n=19 Participants
HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
|
|---|---|---|---|---|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or CD39 and/or TNFR2
CD4+FOXP3-
|
94.65 Treg cells/million cells
Interval 93.8 to 96.3
|
94.3 Treg cells/million cells
Interval 93.7 to 95.2
|
95.585 Treg cells/million cells
Interval 94.0 to 96.8
|
94.7 Treg cells/million cells
Interval 93.2 to 96.0
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or CD39 and/or TNFR2
CD4+FOXP3-CD39+
|
3.395 Treg cells/million cells
Interval 2.82 to 4.625
|
3.93 Treg cells/million cells
Interval 1.55 to 5.16
|
4.015 Treg cells/million cells
Interval 2.135 to 5.34
|
4.83 Treg cells/million cells
Interval 3.7 to 6.05
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or CD39 and/or TNFR2
CD4+FOXP3-CD39+CD45RA+TNFR2-
|
0.828 Treg cells/million cells
Interval 0.4515 to 1.41
|
0.531 Treg cells/million cells
Interval 0.401 to 0.698
|
0.5295 Treg cells/million cells
Interval 0.352 to 0.786
|
0.46 Treg cells/million cells
Interval 0.31 to 0.64
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or CD39 and/or TNFR2
CD4+FOXP3-CD39+CD45RA-TNFR2+
|
1.965 Treg cells/million cells
Interval 0.936 to 2.65
|
2.25 Treg cells/million cells
Interval 0.637 to 2.91
|
2.22 Treg cells/million cells
Interval 0.7095 to 2.9
|
3.24 Treg cells/million cells
Interval 1.85 to 4.15
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or CD39 and/or TNFR2
CD4+FOXP3-CD39+CD45RA-TNFR2-
|
0.6185 Treg cells/million cells
Interval 0.3685 to 0.857
|
0.754 Treg cells/million cells
Interval 0.133 to 0.898
|
0.6635 Treg cells/million cells
Interval 0.2125 to 1.085
|
0.749 Treg cells/million cells
Interval 0.547 to 1.04
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or CD39 and/or TNFR2
CD4+FOXP3-CD39-CD45RA+TNFR2+
|
2.66 Treg cells/million cells
Interval 1.79 to 4.095
|
2.55 Treg cells/million cells
Interval 1.7 to 3.2
|
3.585 Treg cells/million cells
Interval 2.115 to 4.485
|
3.04 Treg cells/million cells
Interval 1.41 to 3.77
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or CD39 and/or TNFR2
CD4+FOXP3-CD39-CD45RA+TNFR2-
|
41.85 Treg cells/million cells
Interval 36.5 to 45.7
|
40.9 Treg cells/million cells
Interval 28.4 to 52.9
|
36.41 Treg cells/million cells
Interval 29.9 to 47.9
|
29.9 Treg cells/million cells
Interval 24.3 to 40.7
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or CD39 and/or TNFR2
CD4+FOXP3-CD39-CD45RA-TNFR2+
|
30.2 Treg cells/million cells
Interval 29.3 to 30.55
|
29.6 Treg cells/million cells
Interval 19.6 to 36.3
|
32.155 Treg cells/million cells
Interval 24.21 to 41.345
|
38.9 Treg cells/million cells
Interval 26.2 to 46.1
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or CD39 and/or TNFR2
CD4+FOXP3-CD39-CD45RA-TNFR2-
|
22.9 Treg cells/million cells
Interval 18.1 to 26.5
|
20 Treg cells/million cells
Interval 16.4 to 23.1
|
21.42 Treg cells/million cells
Interval 18.6 to 25.3
|
20.9 Treg cells/million cells
Interval 17.95 to 25.6
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or CD39 and/or TNFR2
CD4+FOXP3-CD45RA+
|
45.2 Treg cells/million cells
Interval 40.15 to 50.6
|
48 Treg cells/million cells
Interval 39.8 to 55.3
|
41.235 Treg cells/million cells
Interval 33.795 to 52.195
|
33.8 Treg cells/million cells
Interval 25.6 to 47.44
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or CD39 and/or TNFR2
CD4+FOXP3-TNFR2+
|
35.05 Treg cells/million cells
Interval 33.7 to 36.4
|
34.1 Treg cells/million cells
Interval 24.0 to 50.2
|
39.23 Treg cells/million cells
Interval 29.55 to 46.935
|
45.6 Treg cells/million cells
Interval 33.0 to 53.2
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or CD39 and/or TNFR2
CD4+polypositives FOXP3-CD39+CD45RA+TNFR2
|
0.3485 Treg cells/million cells
Interval 0.209 to 0.561
|
0.252 Treg cells/million cells
Interval 0.173 to 0.398
|
0.2795 Treg cells/million cells
Interval 0.221 to 0.472
|
0.336 Treg cells/million cells
Interval 0.244 to 0.478
|
PRIMARY outcome
Timeframe: At the time of the visit for each subject (i.e., Day 0)Population: The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.
The frequency was assessed based on the following range of markers: CD4, CD45RA, CTLA4, OX40 and anti-Foxp3.
Outcome measures
| Measure |
Immune Tolerant Patients Group
n=4 Participants
Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
|
HBeAg Positive Group
n=11 Participants
HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
|
Inactive Carriers Group
n=56 Participants
Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
|
HBeAg Negative Group
n=18 Participants
HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
|
|---|---|---|---|---|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or CTLA4 and/or OX40
CD4+FOXP3+
|
5.555 Treg cells/million cells
Interval 1.8151 to 8.095
|
6.09 Treg cells/million cells
Interval 5.17 to 6.73
|
4.655 Treg cells/million cells
Interval 3.38 to 6.145
|
5.045 Treg cells/million cells
Interval 3.23 to 5.98
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or CTLA4 and/or OX40
CD4+FOXP3+CD45RA+
|
17.8 Treg cells/million cells
Interval 15.8 to 19.7
|
17.4 Treg cells/million cells
Interval 7.16 to 22.8
|
18.5 Treg cells/million cells
Interval 13.01 to 26.3
|
16.6 Treg cells/million cells
Interval 8.81 to 24.5
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or CTLA4 and/or OX40
CD4+FOXP3+CD45RA+CTLA4+OX40-
|
1.5 Treg cells/million cells
Interval 1.25 to 1.66
|
1.75 Treg cells/million cells
Interval 1.24 to 2.63
|
1.32 Treg cells/million cells
Interval 0.47 to 2.35
|
1.09 Treg cells/million cells
Interval 0.74 to 2.4
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or CTLA4 and/or OX40
CD4+FOXP3+CD45RA+CTLA4-OX40+
|
0.107 Treg cells/million cells
Interval 0.0722 to 0.26
|
0.174 Treg cells/million cells
Interval 0.106 to 0.205
|
0.11 Treg cells/million cells
Interval 0.06 to 0.31
|
0.126 Treg cells/million cells
Interval 0.06 to 0.252
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or CTLA4 and/or OX40
CD4+FOXP3+CD45RA+CTLA4-OX40-
|
15.9 Treg cells/million cells
Interval 14.0 to 17.9
|
15.2 Treg cells/million cells
Interval 5.85 to 20.9
|
16.1 Treg cells/million cells
Interval 11.3 to 23.72
|
13.2 Treg cells/million cells
Interval 6.32 to 21.9
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or CTLA4 and/or OX40
CD4+FOXP3+CD45RA-CTLA4+OX40+
|
1.73 Treg cells/million cells
Interval 1.3 to 2.53
|
2.08 Treg cells/million cells
Interval 1.22 to 4.04
|
1.345 Treg cells/million cells
Interval 0.631 to 2.13
|
2.38 Treg cells/million cells
Interval 0.84 to 4.15
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or CTLA4 and/or OX40
CD4+FOXP3+CD45RA-CTLA4+OX40-
|
28.4 Treg cells/million cells
Interval 25.0 to 30.4
|
41 Treg cells/million cells
Interval 26.5 to 47.4
|
24.5 Treg cells/million cells
Interval 15.9 to 38.3
|
31.7 Treg cells/million cells
Interval 28.08 to 39.1
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or CTLA4 and/or OX40
CD4+FOXP3+CD45RA-CTLA4-OX40+
|
8.16 Treg cells/million cells
Interval 6.28 to 11.9
|
1.915 Treg cells/million cells
Interval 0.872 to 3.26
|
1.515 Treg cells/million cells
Interval 0.62 to 2.54
|
1.39 Treg cells/million cells
Interval 0.586 to 1.98
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or CTLA4 and/or OX40
CD4+FOXP3+CD45RA-CTLA4-OX40-
|
43.9 Treg cells/million cells
Interval 39.5 to 47.5
|
42 Treg cells/million cells
Interval 26.4 to 47.3
|
47.9 Treg cells/million cells
Interval 39.5 to 56.2
|
38.1 Treg cells/million cells
Interval 32.6 to 49.3
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or CTLA4 and/or OX40
CD4+FOXP3+CTLA4+
|
31.8 Treg cells/million cells
Interval 27.9 to 34.6
|
45 Treg cells/million cells
Interval 31.8 to 53.5
|
27.5 Treg cells/million cells
Interval 17.64 to 40.9
|
39.3 Treg cells/million cells
Interval 32.1 to 51.2
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or CTLA4 and/or OX40
CD4+FOXP3+OX40+
|
10.1 Treg cells/million cells
Interval 8.15 to 14.7
|
5.15 Treg cells/million cells
Interval 2.68 to 6.51
|
3.66 Treg cells/million cells
Interval 1.72 to 6.15
|
3.94 Treg cells/million cells
Interval 2.16 to 7.55
|
|
Frequency of CD4+Foxp3+ Expressing CD45RA and/or CTLA4 and/or OX40
CD4+polypositives FOXP3+CD45RA+CTLA4+OX40
|
0.188 Treg cells/million cells
Interval 0.0722 to 0.364
|
0.118 Treg cells/million cells
Interval 0.0709 to 0.381
|
0.19 Treg cells/million cells
Interval 0.0322 to 0.37
|
0.283 Treg cells/million cells
Interval 0.0993 to 0.503
|
PRIMARY outcome
Timeframe: At the time of the visit for each subject (i.e., Day 0)Population: The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.
The frequency was assessed based on the following range of markers: CD4, CD45RA, CTLA4, OX40 and anti-Foxp3.
Outcome measures
| Measure |
Immune Tolerant Patients Group
n=4 Participants
Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
|
HBeAg Positive Group
n=11 Participants
HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
|
Inactive Carriers Group
n=56 Participants
Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
|
HBeAg Negative Group
n=18 Participants
HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
|
|---|---|---|---|---|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or CTLA4 and/or OX40
CD4+FOXP3-CTLA4+
|
3.825 Treg cells/million cells
Interval 2.92 to 52.015
|
2.34 Treg cells/million cells
Interval 2.13 to 3.62
|
3.4 Treg cells/million cells
Interval 2.14 to 4.52
|
3.55 Treg cells/million cells
Interval 2.0 to 6.47
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or CTLA4 and/or OX40
CD4+FOXP3-
|
94.45 Treg cells/million cells
Interval 91.9 to 98.2
|
93.9 Treg cells/million cells
Interval 93.3 to 94.8
|
95.395 Treg cells/million cells
Interval 93.85 to 96.645
|
94.95 Treg cells/million cells
Interval 94.0 to 96.8
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or CTLA4 and/or OX40
CD4+FOXP3-CD45RA+
|
45.2 Treg cells/million cells
Interval 19.455 to 52.1
|
46.4 Treg cells/million cells
Interval 37.1 to 53.0
|
36.05 Treg cells/million cells
Interval 24.055 to 46.25
|
31.55 Treg cells/million cells
Interval 22.2 to 38.9
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or CTLA4 and/or OX40
CD4+FOXP3-CD45RA+CTLA4+OX40-
|
0.2755 Treg cells/million cells
Interval 0.0746 to 0.411
|
0.263 Treg cells/million cells
Interval 0.212 to 0.456
|
0.2505 Treg cells/million cells
Interval 0.0902 to 0.4915
|
0.265 Treg cells/million cells
Interval 0.0806 to 0.475
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or CTLA4 and/or OX40
CD4+FOXP3-CD45RA+CTLA4-OX40+
|
0.1715 Treg cells/million cells
Interval 0.0816 to 0.1975
|
0.287 Treg cells/million cells
Interval 0.128 to 0.488
|
0.1645 Treg cells/million cells
Interval 0.0503 to 0.5495
|
0.243 Treg cells/million cells
Interval 0.11 to 0.519
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or CTLA4 and/or OX40
CD4+FOXP3-CD45RA+CTLA4-OX40-
|
44.55 Treg cells/million cells
Interval 18.9001 to 51.55
|
46 Treg cells/million cells
Interval 36.7 to 52.0
|
34.4 Treg cells/million cells
Interval 23.4 to 44.55
|
25.5 Treg cells/million cells
Interval 18.0 to 35.4
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or CTLA4 and/or OX40
CD4+FOXP3-CD45RA-CTLA4+OX40+
|
0.508 Treg cells/million cells
Interval 0.2425 to 50.0535
|
0.242 Treg cells/million cells
Interval 0.167 to 0.434
|
0.2645 Treg cells/million cells
Interval 0.0736 to 0.619
|
0.6175 Treg cells/million cells
Interval 0.31 to 1.37
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or CTLA4 and/or OX40
CD4+FOXP3-CD45RA-CTLA4+OX40-
|
2.35 Treg cells/million cells
Interval 0.9599 to 2.865
|
1.87 Treg cells/million cells
Interval 1.52 to 2.54
|
2.39 Treg cells/million cells
Interval 1.79 to 3.34
|
1.845 Treg cells/million cells
Interval 1.36 to 3.58
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or CTLA4 and/or OX40
CD4+FOXP3-CD45RA-CTLA4-OX40+
|
3.035 Treg cells/million cells
Interval 1.2051 to 4.495
|
2.48 Treg cells/million cells
Interval 0.763 to 4.36
|
1.78 Treg cells/million cells
Interval 0.603 to 5.855
|
4.015 Treg cells/million cells
Interval 1.71 to 11.3
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or CTLA4 and/or OX40
CD4+FOXP3-CD45RA-CTLA4-OX40-
|
41.25 Treg cells/million cells
Interval 19.5529 to 49.1
|
51.4 Treg cells/million cells
Interval 39.7 to 58.4
|
53.05 Treg cells/million cells
Interval 47.0 to 66.8
|
56.05 Treg cells/million cells
Interval 51.4 to 68.2
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or CTLA4 and/or OX40
CD4+FOXP3-OX40+
|
5.235 Treg cells/million cells
Interval 3.5 to 53.095
|
3.23 Treg cells/million cells
Interval 1.34 to 5.2
|
2.27 Treg cells/million cells
Interval 0.858 to 7.995
|
5.675 Treg cells/million cells
Interval 2.65 to 13.1
|
|
Frequency of CD4+Foxp3- Expressing CD45RA and/or CTLA4 and/or OX40
CD4+polypositives FOXP3-CD45RA+CTLA4+OX40
|
0.0488 Treg cells/million cells
Interval 0.0392 to 0.2813
|
0.0366 Treg cells/million cells
Interval 0.0252 to 0.0662
|
0.0359 Treg cells/million cells
Interval 0.0195 to 0.0803
|
0.0646 Treg cells/million cells
Interval 0.0349 to 0.126
|
PRIMARY outcome
Timeframe: At the time of the visit for each subject (i.e., Day 0)Population: The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.
The frequency was assessed based on the following range of markers: CD4, CD69, LAP and anti-Foxp3.
Outcome measures
| Measure |
Immune Tolerant Patients Group
n=4 Participants
Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
|
HBeAg Positive Group
n=9 Participants
HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
|
Inactive Carriers Group
n=47 Participants
Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
|
HBeAg Negative Group
n=18 Participants
HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
|
|---|---|---|---|---|
|
Frequency of HBs- and HBc-specific CD4+Foxp3+ Expressing CD69 and/or LAP in Fresh Samples
HBc CD4+FOXP3+
|
0.35 Treg cells/million cells
Interval 0.26 to 0.36
|
0.21 Treg cells/million cells
Interval 0.0001 to 0.53
|
0.42 Treg cells/million cells
Interval 0.07 to 0.67
|
0.52 Treg cells/million cells
Interval 0.12 to 0.81
|
|
Frequency of HBs- and HBc-specific CD4+Foxp3+ Expressing CD69 and/or LAP in Fresh Samples
HBc CD4+FOXP3+CD69+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.51 Treg cells/million cells
Interval 0.08 to 1.08
|
0.84 Treg cells/million cells
Interval 0.0001 to 2.8
|
1.0115 Treg cells/million cells
Interval 0.0001 to 1.56
|
|
Frequency of HBs- and HBc-specific CD4+Foxp3+ Expressing CD69 and/or LAP in Fresh Samples
HBc CD4+FOXP3+LAP+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.08
|
0.02 Treg cells/million cells
Interval 0.0001 to 0.087
|
0.04 Treg cells/million cells
Interval 0.0001 to 0.296
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.158
|
|
Frequency of HBs- and HBc-specific CD4+Foxp3+ Expressing CD69 and/or LAP in Fresh Samples
HBc CD4+FOXP3+CD69+LAP+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.072
|
0.082 Treg cells/million cells
Interval 0.0001 to 0.32
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.128
|
|
Frequency of HBs- and HBc-specific CD4+Foxp3+ Expressing CD69 and/or LAP in Fresh Samples
HBc CD4+FOXP3+CD69+LAP-
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.55
|
0.69 Treg cells/million cells
Interval 0.21 to 1.14
|
1.09 Treg cells/million cells
Interval 0.0001 to 2.54
|
0.9815 Treg cells/million cells
Interval 0.0001 to 1.93
|
|
Frequency of HBs- and HBc-specific CD4+Foxp3+ Expressing CD69 and/or LAP in Fresh Samples
HBc CD4+FOXP3+CD69-LAP+
|
0.049 Treg cells/million cells
Interval 0.0001 to 0.597
|
0.002 Treg cells/million cells
Interval 0.0001 to 0.091
|
0.013 Treg cells/million cells
Interval 0.0001 to 0.149
|
0.0086 Treg cells/million cells
Interval 0.0001 to 0.194
|
|
Frequency of HBs- and HBc-specific CD4+Foxp3+ Expressing CD69 and/or LAP in Fresh Samples
HBc CD4+FOXP3+CD69-LAP-
|
0.6 Treg cells/million cells
Interval 0.3 to 1.3
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.1
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.1
|
|
Frequency of HBs- and HBc-specific CD4+Foxp3+ Expressing CD69 and/or LAP in Fresh Samples
HBs CD4+FOXP3+
|
0.305 Treg cells/million cells
Interval 0.0801 to 0.675
|
0.25 Treg cells/million cells
Interval 0.0001 to 0.55
|
0.0101 Treg cells/million cells
Interval 0.0001 to 0.2
|
0.16 Treg cells/million cells
Interval 0.0001 to 0.66
|
|
Frequency of HBs- and HBc-specific CD4+Foxp3+ Expressing CD69 and/or LAP in Fresh Samples
HBs CD4+FOXP3+CD69+
|
2.0101 Treg cells/million cells
Interval 0.0001 to 4.135
|
0.95 Treg cells/million cells
Interval 0.02 to 1.29
|
0.905 Treg cells/million cells
Interval 0.0451 to 1.885
|
0.5315 Treg cells/million cells
Interval 0.0001 to 2.45
|
|
Frequency of HBs- and HBc-specific CD4+Foxp3+ Expressing CD69 and/or LAP in Fresh Samples
HBs CD4+FOXP3+LAP+
|
1.184 Treg cells/million cells
Interval 0.5501 to 1.984
|
0.07 Treg cells/million cells
Interval 0.0001 to 0.641
|
0.107 Treg cells/million cells
Interval 0.0001 to 0.5965
|
0.0476 Treg cells/million cells
Interval 0.0001 to 0.489
|
|
Frequency of HBs- and HBc-specific CD4+Foxp3+ Expressing CD69 and/or LAP in Fresh Samples
HBs CD4+FOXP3+CD69+LAP+
|
0.2201 Treg cells/million cells
Interval 0.0001 to 1.395
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.299
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.149
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.23
|
|
Frequency of HBs- and HBc-specific CD4+Foxp3+ Expressing CD69 and/or LAP in Fresh Samples
HBs CD4+FOXP3+CD69+LAP-
|
1.025 Treg cells/million cells
Interval 0.0751 to 3.055
|
0.65 Treg cells/million cells
Interval 0.34 to 1.31
|
1.01 Treg cells/million cells
Interval 0.4535 to 2.2
|
0.5215 Treg cells/million cells
Interval 0.0001 to 2.16
|
|
Frequency of HBs- and HBc-specific CD4+Foxp3+ Expressing CD69 and/or LAP in Fresh Samples
HBs CD4+FOXP3+CD69-LAP+
|
0.5065 Treg cells/million cells
Interval 0.1731 to 1.064
|
0.033 Treg cells/million cells
Interval 0.0001 to 0.346
|
0.0805 Treg cells/million cells
Interval 0.0001 to 0.392
|
0.1335 Treg cells/million cells
Interval 0.0001 to 0.394
|
|
Frequency of HBs- and HBc-specific CD4+Foxp3+ Expressing CD69 and/or LAP in Fresh Samples
HBs CD4+FOXP3+CD69-LAP-
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.4501
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.1
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0501
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.6
|
PRIMARY outcome
Timeframe: At the time of the visit for each subject (i.e., Day 0)Population: The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.
The frequency was assessed based on the following range of markers: CD4, CD69, LAP and anti-Foxp3.
Outcome measures
| Measure |
Immune Tolerant Patients Group
n=4 Participants
Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
|
HBeAg Positive Group
n=11 Participants
HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
|
Inactive Carriers Group
n=56 Participants
Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
|
HBeAg Negative Group
n=19 Participants
HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
|
|---|---|---|---|---|
|
Frequency of HBs- and HBc-specific CD4+Foxp3- Expressing CD69 and/or LAP in Fresh Samples
HBs CD4+FOXP3-
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0501
|
0.1 Treg cells/million cells
Interval 0.0001 to 0.5
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.35
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of HBs- and HBc-specific CD4+Foxp3- Expressing CD69 and/or LAP in Fresh Samples
HBc CD4+FOXP3-
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.5
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of HBs- and HBc-specific CD4+Foxp3- Expressing CD69 and/or LAP in Fresh Samples
HBc CD4+FOXP3-CD69+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.6246
|
0.16 Treg cells/million cells
Interval 0.0001 to 0.22
|
0.28 Treg cells/million cells
Interval 0.0001 to 1.26
|
0.25 Treg cells/million cells
Interval 0.053 to 0.91
|
|
Frequency of HBs- and HBc-specific CD4+Foxp3- Expressing CD69 and/or LAP in Fresh Samples
HBc CD4+FOXP3-LAP+
|
0.0051 Treg cells/million cells
Interval 0.0001 to 0.05
|
0.02 Treg cells/million cells
Interval 0.0001 to 0.08
|
0.0345 Treg cells/million cells
Interval 0.0001 to 0.147
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.104
|
|
Frequency of HBs- and HBc-specific CD4+Foxp3- Expressing CD69 and/or LAP in Fresh Samples
HBc CD4+FOXP3-CD69+LAP+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.037
|
0.01 Treg cells/million cells
Interval 0.0001 to 0.0515
|
0.0126 Treg cells/million cells
Interval 0.0001 to 0.0373
|
|
Frequency of HBs- and HBc-specific CD4+Foxp3- Expressing CD69 and/or LAP in Fresh Samples
HBc CD4+FOXP3-CD69+LAP-
|
0.33 Treg cells/million cells
Interval 0.1351 to 0.828
|
0.15 Treg cells/million cells
Interval 0.0001 to 0.27
|
0.185 Treg cells/million cells
Interval 0.0001 to 1.245
|
0.279 Treg cells/million cells
Interval 0.078 to 0.94
|
|
Frequency of HBs- and HBc-specific CD4+Foxp3- Expressing CD69 and/or LAP in Fresh Samples
HBc CD4+FOXP3-CD69-LAP+
|
0.0672 Treg cells/million cells
Interval 0.0158 to 0.1165
|
0.025 Treg cells/million cells
Interval 0.0001 to 0.0675
|
0.0165 Treg cells/million cells
Interval 0.0001 to 0.108
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0642
|
|
Frequency of HBs- and HBc-specific CD4+Foxp3- Expressing CD69 and/or LAP in Fresh Samples
HBc CD4+FOXP3-CD69-LAP-
|
0.2501 Treg cells/million cells
Interval 0.0001 to 1.25
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.2
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.1
|
|
Frequency of HBs- and HBc-specific CD4+Foxp3- Expressing CD69 and/or LAP in Fresh Samples
HBs CD4+FOXP3-CD69+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 1.4146
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.068 Treg cells/million cells
Interval 0.0001 to 0.475
|
0.07 Treg cells/million cells
Interval 0.0001 to 0.24
|
|
Frequency of HBs- and HBc-specific CD4+Foxp3- Expressing CD69 and/or LAP in Fresh Samples
HBs CD4+FOXP3-LAP+
|
0.2251 Treg cells/million cells
Interval 0.0001 to 0.555
|
0.0913 Treg cells/million cells
Interval 0.0001 to 0.219
|
0.0993 Treg cells/million cells
Interval 0.0001 to 0.3005
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.328
|
|
Frequency of HBs- and HBc-specific CD4+Foxp3- Expressing CD69 and/or LAP in Fresh Samples
HBs CD4+FOXP3-CD69+LAP+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0309
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.044
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0229
|
0.0057 Treg cells/million cells
Interval 0.0001 to 0.075
|
|
Frequency of HBs- and HBc-specific CD4+Foxp3- Expressing CD69 and/or LAP in Fresh Samples
HBs CD4+FOXP3-CD69+LAP-
|
0.1901 Treg cells/million cells
Interval 0.0001 to 1.573
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.011
|
0.1 Treg cells/million cells
Interval 0.0001 to 0.4465
|
0.087 Treg cells/million cells
Interval 0.0001 to 0.233
|
|
Frequency of HBs- and HBc-specific CD4+Foxp3- Expressing CD69 and/or LAP in Fresh Samples
HBs CD4+FOXP3-CD69-LAP+
|
0.334 Treg cells/million cells
Interval 0.0736 to 0.5597
|
0.173 Treg cells/million cells
Interval 0.0001 to 0.208
|
0.1011 Treg cells/million cells
Interval 0.0001 to 0.2795
|
0.046 Treg cells/million cells
Interval 0.0001 to 0.244
|
|
Frequency of HBs- and HBc-specific CD4+Foxp3- Expressing CD69 and/or LAP in Fresh Samples
HBs CD4+FOXP3-CD69-LAP-
|
0.45 Treg cells/million cells
Interval 0.0501 to 1.0
|
0.1 Treg cells/million cells
Interval 0.0001 to 0.5
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.1
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
PRIMARY outcome
Timeframe: At the time of the visit for each subject (i.e., Day 0)Population: The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.
The frequency was assessed based on the following range of markers: CD4, CD69, LAP and anti-Foxp3.
Outcome measures
| Measure |
Immune Tolerant Patients Group
n=1 Participants
Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
|
HBeAg Positive Group
n=4 Participants
HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
|
Inactive Carriers Group
n=26 Participants
Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
|
HBeAg Negative Group
n=9 Participants
HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
|
|---|---|---|---|---|
|
Frequency of HBc-specific CD4+Foxp3+ Expressing CD69 and/or LAP in Frozen Samples
CD4+FOXP3+CD69+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.2301
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.62
|
0.8 Treg cells/million cells
Interval 0.0001 to 2.2
|
|
Frequency of HBc-specific CD4+Foxp3+ Expressing CD69 and/or LAP in Frozen Samples
CD4+FOXP3+LAP+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.1671
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.067
|
0.29 Treg cells/million cells
Interval 0.0001 to 0.67
|
|
Frequency of HBc-specific CD4+Foxp3+ Expressing CD69 and/or LAP in Frozen Samples
CD4+FOXP3+CD69+LAP+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.1915
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.014
|
0.259 Treg cells/million cells
Interval 0.01 to 0.61
|
|
Frequency of HBc-specific CD4+Foxp3+ Expressing CD69 and/or LAP in Frozen Samples
CD4+FOXP3+CD69+LAP-
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0351
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.67
|
0.2 Treg cells/million cells
Interval 0.0001 to 2.2
|
|
Frequency of HBc-specific CD4+Foxp3+ Expressing CD69 and/or LAP in Frozen Samples
CD4+FOXP3+CD69-LAP+
|
0.74 Treg cells/million cells
Interval 0.74 to 0.74
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.055 Treg cells/million cells
Interval 0.0001 to 0.25
|
0.06 Treg cells/million cells
Interval 0.0001 to 0.274
|
SECONDARY outcome
Timeframe: At the time of the visit for each subject (i.e., Day 0)Population: The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.
The frequency was assessed based on the following range of markers: CD4, CD40-L, IFNg, IL-2 and IL-17. Note: The precision of the measure (i.e., four decimals) of median and inter-quartile range is not sufficient to distinguish between the values median, lower and upper limits of inter-quartile range for some of the data presented within the table below (e.g., median=0.0001 and inter-quartile range=0.0001 to 0.0001).
Outcome measures
| Measure |
Immune Tolerant Patients Group
n=4 Participants
Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
|
HBeAg Positive Group
n=11 Participants
HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
|
Inactive Carriers Group
n=57 Participants
Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
|
HBeAg Negative Group
n=20 Participants
HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
|
|---|---|---|---|---|
|
Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples
HBs CD4+CD40L+IL2-IFNg+IL17-
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples
HBc CD4+CD40L+
|
0.0181 Treg cells/million cells
Interval 0.0056 to 0.0294
|
0.0032 Treg cells/million cells
Interval 0.0001 to 0.0209
|
0.0013 Treg cells/million cells
Interval 0.0001 to 0.0255
|
0.0135 Treg cells/million cells
Interval 0.0001 to 0.0271
|
|
Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples
HBc CD4+IFNg+
|
0.0164 Treg cells/million cells
Interval 0.0001 to 0.038
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples
HBc CD4+IL2+
|
0.0044 Treg cells/million cells
Interval 0.0001 to 0.0255
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0023
|
0.0014 Treg cells/million cells
Interval 0.0001 to 0.012
|
0.0004 Treg cells/million cells
Interval 0.0001 to 0.0066
|
|
Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples
HBc CD4+IL17+
|
0.0128 Treg cells/million cells
Interval 0.0015 to 0.0277
|
0.0025 Treg cells/million cells
Interval 0.0001 to 0.009
|
0.0004 Treg cells/million cells
Interval 0.0001 to 0.0043
|
0.0014 Treg cells/million cells
Interval 0.0001 to 0.0089
|
|
Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples
HBc CD4+CD40L+IL2+IFNg+IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0017
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples
HBc CD4+CD40L+IL2+IFNg+IL17-
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples
HBc CD4+CD40L+IL2-IFNg+IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples
HBc CD4+CD40L+IL2-IFNg+IL17-
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples
HBc CD4+CD40L+IL2+IFNg-IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples
HBc CD4+CD40L+IL2+IFNg-IL17-
|
0.0018 Treg cells/million cells
Interval 0.0007 to 0.003
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0018
|
0.0025 Treg cells/million cells
Interval 0.0001 to 0.0066
|
0.0011 Treg cells/million cells
Interval 0.0001 to 0.0036
|
|
Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples
HBc CD4+CD40L+IL2-IFNg-IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0024
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.002
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples
HBc CD4+CD40L+IL2-IFNg-IL17-
|
0.0158 Treg cells/million cells
Interval 0.0051 to 0.026
|
0.0023 Treg cells/million cells
Interval 0.0001 to 0.0122
|
0.0013 Treg cells/million cells
Interval 0.0001 to 0.0216
|
0.0113 Treg cells/million cells
Interval 0.0001 to 0.0259
|
|
Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples
HBc CD4+CD40L-IL2+IFNg+IL17+
|
0.0038 Treg cells/million cells
Interval 0.0001 to 0.024
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples
HBc CD4+CD40L-IL2+IFNg+IL17-
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0017
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples
HBc CD4+CD40L-IL2-IFNg+IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0088
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples
HBc CD4+CD40L-IL2-IFNg+IL17-
|
0.0023 Treg cells/million cells
Interval 0.0001 to 0.0072
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0006
|
|
Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples
HBc CD4+CD40L-IL2+IFNg-IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0012
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0002
|
|
Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples
HBc CD4+CD40L-IL2+IFNg-IL17-
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0013
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0002
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.002
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0023
|
|
Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples
HBc CD4+CD40L-IL2-IFNg-IL17+
|
0.0006 Treg cells/million cells
Interval 0.0001 to 0.0015
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0018
|
0.0012 Treg cells/million cells
Interval 0.0001 to 0.0054
|
0.0022 Treg cells/million cells
Interval 0.0001 to 0.0036
|
|
Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples
HBs CD4+CD40L+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0051
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0062
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0127
|
0.0053 Treg cells/million cells
Interval 0.0001 to 0.0207
|
|
Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples
HBs CD4+IFNg+
|
0.0011 Treg cells/million cells
Interval 0.0001 to 0.0143
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples
HBs CD4+IL2+
|
0.0049 Treg cells/million cells
Interval 0.0001 to 0.011
|
0.0064 Treg cells/million cells
Interval 0.0001 to 0.0191
|
0.0021 Treg cells/million cells
Interval 0.0001 to 0.0151
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0062
|
|
Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples
HBs CD4+IL17+
|
0.0013 Treg cells/million cells
Interval 0.0001 to 0.0165
|
0.0058 Treg cells/million cells
Interval 0.0001 to 0.0486
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0024
|
0.0002 Treg cells/million cells
Interval 0.0001 to 0.0061
|
|
Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples
HBs CD4+CD40L+IL2+IFNg+IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples
HBs CD4+CD40L+IL2+IFNg+IL17-
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples
HBs CD4+CD40L+IL2-IFNg+IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples
HBs CD4+CD40L+IL2+IFNg-IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0013
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples
HBs CD4+CD40L+IL2+IFNg-IL17-
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0007
|
0.0015 Treg cells/million cells
Interval 0.0001 to 0.0038
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0028
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0021
|
|
Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples
HBs CD4+CD40L+IL2-IFNg-IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0007
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples
HBs CD4+CD40L+IL2-IFNg-IL17-
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0051
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0095
|
0.0041 Treg cells/million cells
Interval 0.0001 to 0.0181
|
|
Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples
HBs CD4+CD40L-IL2+IFNg+IL17+
|
0.0025 Treg cells/million cells
Interval 0.0001 to 0.0075
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples
HBs CD4+CD40L-IL2+IFNg+IL17-
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples
HBs CD4+CD40L-IL2-IFNg+IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0068
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples
HBs CD4+CD40L-IL2-IFNg+IL17-
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0015
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples
HBs CD4+CD40L-IL2+IFNg-IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0036
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.004
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples
HBs CD4+CD40L-IL2+IFNg-IL17-
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0044
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0143
|
0.0017 Treg cells/million cells
Interval 0.0001 to 0.0108
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0035
|
|
Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples
HBs CD4+CD40L-IL2-IFNg-IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0019 Treg cells/million cells
Interval 0.0001 to 0.004
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0021
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.001
|
SECONDARY outcome
Timeframe: At the time of the visit for each subject (i.e., Day 0)Population: The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.
The frequency was assessed based on the following range of markers: CD8, CD40-L, IFNg, IL-2 and IL-17. Note: The precision of the measure (i.e., four decimals) of median and inter-quartile range is not sufficient to distinguish between the values median, lower and upper limits of inter-quartile range for some of the data presented within the table below (e.g., median=0.0001 and inter-quartile range=0.0001 to 0.0001).
Outcome measures
| Measure |
Immune Tolerant Patients Group
n=4 Participants
Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
|
HBeAg Positive Group
n=11 Participants
HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
|
Inactive Carriers Group
n=57 Participants
Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
|
HBeAg Negative Group
n=20 Participants
HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
|
|---|---|---|---|---|
|
Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples
HBc CD8+CD40L+
|
0.004 Treg cells/million cells
Interval 0.002 to 0.0071
|
0.0034 Treg cells/million cells
Interval 0.0001 to 0.0106
|
0.0002 Treg cells/million cells
Interval 0.0001 to 0.0128
|
0.0065 Treg cells/million cells
Interval 0.0001 to 0.0098
|
|
Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples
HBc CD8+IFNg+
|
0.0346 Treg cells/million cells
Interval 0.0197 to 0.0609
|
0.003 Treg cells/million cells
Interval 0.0001 to 0.0117
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0048
|
0.0003 Treg cells/million cells
Interval 0.0001 to 0.0197
|
|
Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples
HBc CD8+IL2+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0053
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0052
|
0.001 Treg cells/million cells
Interval 0.0001 to 0.0101
|
|
Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples
HBc CD8+IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0153
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0345
|
0.0021 Treg cells/million cells
Interval 0.0001 to 0.0523
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0097
|
|
Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples
HBc CD8+CD40L+IL2+IFNg+IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0005
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples
HBc CD8+CD40L+IL2+IFNg+IL17-
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples
HBc CD8+CD40L+IL2-IFNg+IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0016
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples
HBc CD8+CD40L+IL2-IFNg+IL17-
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0017
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples
HBc CD8+CD40L+IL2+IFNg-IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples
HBc CD8+CD40L+IL2+IFNg-IL17-
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0016
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples
HBc CD8+CD40L+IL2-IFNg-IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples
HBc CD8+CD40L+IL2-IFNg-IL17-
|
0.0039 Treg cells/million cells
Interval 0.002 to 0.007
|
0.0052 Treg cells/million cells
Interval 0.0001 to 0.0106
|
0.0002 Treg cells/million cells
Interval 0.0001 to 0.0126
|
0.0066 Treg cells/million cells
Interval 0.0001 to 0.0111
|
|
Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples
HBc CD8+CD40L-IL2+IFNg+IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0005
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0034
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples
HBc CD8+CD40L-IL2+IFNg+IL17-
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0014
|
|
Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples
HBc CD8+CD40L-IL2-IFNg+IL17+
|
0.0034 Treg cells/million cells
Interval 0.0001 to 0.0155
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples
HBc CD8+CD40L-IL2-IFNg+IL17-
|
0.0251 Treg cells/million cells
Interval 0.0115 to 0.0548
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0097
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0048
|
0.0008 Treg cells/million cells
Interval 0.0001 to 0.0113
|
|
Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples
HBc CD8+CD40L-IL2+IFNg-IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.001
|
|
Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples
HBc CD8+CD40L-IL2+IFNg-IL17-
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0035
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0041
|
|
Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples
HBc CD8+CD40L-IL2-IFNg-IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0025
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.004
|
0.0021 Treg cells/million cells
Interval 0.0001 to 0.045
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0044
|
|
Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples
HBs CD8+CD40L+
|
0.0046 Treg cells/million cells
Interval 0.0005 to 0.009
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0057
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0118
|
0.0002 Treg cells/million cells
Interval 0.0001 to 0.0073
|
|
Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples
HBs CD8+IFNg+
|
0.0167 Treg cells/million cells
Interval 0.0087 to 0.0324
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0064
|
0.0027 Treg cells/million cells
Interval 0.0001 to 0.0155
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0117
|
|
Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples
HBs CD8+IL2+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.011
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.031
|
0.0013 Treg cells/million cells
Interval 0.0001 to 0.0066
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0049
|
|
Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples
HBs CD8+IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0158
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0448
|
0.0015 Treg cells/million cells
Interval 0.0001 to 0.0462
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0395
|
|
Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples
HBs CD8+CD40L+IL2+IFNg+IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0026
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples
HBs CD8+CD40L+IL2+IFNg+IL17-
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples
HBs CD8+CD40L+IL2-IFNg+IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples
HBs CD8+CD40L+IL2-IFNg+IL17-
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0019
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples
HBs CD8+CD40L+IL2+IFNg-IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples
HBs CD8+CD40L+IL2+IFNg-IL17-
|
0.0017 Treg cells/million cells
Interval 0.0001 to 0.0074
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0003
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples
HBs CD8+CD40L+IL2-IFNg-IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples
HBs CD8+CD40L+IL2-IFNg-IL17-
|
0.0046 Treg cells/million cells
Interval 0.0005 to 0.0083
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0083
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0106
|
0.0002 Treg cells/million cells
Interval 0.0001 to 0.0038
|
|
Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples
HBs CD8+CD40L-IL2+IFNg+IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0139
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples
HBs CD8+CD40L-IL2+IFNg+IL17-
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples
HBs CD8+CD40L-IL2-IFNg+IL17+
|
0.0016 Treg cells/million cells
Interval 0.0001 to 0.0035
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0038
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples
HBs CD8+CD40L-IL2-IFNg+IL17-
|
0.0126 Treg cells/million cells
Interval 0.0056 to 0.0198
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0067
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0126
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0348
|
|
Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples
HBs CD8+CD40L-IL2+IFNg-IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0019
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0019
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0009
|
|
Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples
HBs CD8+CD40L-IL2+IFNg-IL17-
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0041
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0066
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples
HBs CD8+CD40L-IL2-IFNg-IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.029
|
0.0026 Treg cells/million cells
Interval 0.0001 to 0.0446
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0269
|
SECONDARY outcome
Timeframe: At the time of the visit for each subject (i.e., Day 0)Population: The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.
The frequency was assessed based on the following range of markers: CD4, CD40-L, IFNg, IL-2 and IL-17. Note: The precision of the measure (i.e., four decimals) of median and inter-quartile range is not sufficient to distinguish between the values median, lower and upper limits of inter-quartile range for some of the data presented within the table below (e.g., median=0.0001 and inter-quartile range=0.0001 to 0.0001).
Outcome measures
| Measure |
Immune Tolerant Patients Group
n=2 Participants
Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
|
HBeAg Positive Group
n=7 Participants
HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
|
Inactive Carriers Group
n=40 Participants
Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
|
HBeAg Negative Group
n=11 Participants
HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
|
|---|---|---|---|---|
|
Frequency of CD4+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples
HBc CD4+CD40L+
|
0.0048 Treg cells/million cells
Interval 0.0001 to 0.0095
|
0.108 Treg cells/million cells
Interval 0.0148 to 0.337
|
0.0336 Treg cells/million cells
Interval 0.0001 to 0.2448
|
0.032 Treg cells/million cells
Interval 0.0001 to 0.453
|
|
Frequency of CD4+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples
HBc CD4+IFNg+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0099
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0097
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD4+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples
HBc CD4+IL2+
|
0.0161 Treg cells/million cells
Interval 0.0001 to 0.0321
|
0.0128 Treg cells/million cells
Interval 0.0001 to 0.0486
|
0.0033 Treg cells/million cells
Interval 0.0001 to 0.0245
|
0.0083 Treg cells/million cells
Interval 0.0001 to 0.0368
|
|
Frequency of CD4+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples
HBc CD4+IL17+
|
0.0063 Treg cells/million cells
Interval 0.0001 to 0.0124
|
0.0012 Treg cells/million cells
Interval 0.0001 to 0.0046
|
0.0047 Treg cells/million cells
Interval 0.0002 to 0.0154
|
0.0037 Treg cells/million cells
Interval 0.0007 to 0.0139
|
|
Frequency of CD4+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples
HBc CD4+CD40L+IL2+IFNg+IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD4+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples
HBc CD4+CD40L+IL2+IFNg+IL17-
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD4+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples
HBc CD4+CD40L+IL2-IFNg+IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD4+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples
HBc CD4+CD40L+IL2-IFNg+IL17-
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0014
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0007
|
|
Frequency of CD4+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples
HBc CD4+CD40L+IL2+IFNg-IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD4+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples
HBc CD4+CD40L+IL2+IFNg-IL17-
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0009
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD4+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples
HBc CD4+CD40L+IL2-IFNg-IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD4+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples
HBc CD4+CD40L+IL2-IFNg-IL17-
|
0.0048 Treg cells/million cells
Interval 0.0001 to 0.0095
|
0.105 Treg cells/million cells
Interval 0.0148 to 0.347
|
0.031 Treg cells/million cells
Interval 0.0001 to 0.2438
|
0.031 Treg cells/million cells
Interval 0.0001 to 0.45
|
|
Frequency of CD4+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples
HBc CD4+CD40L-IL2+IFNg+IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD4+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples
HBc CD4+CD40L-IL2+IFNg+IL17-
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0008
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD4+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples
HBc CD4+CD40L-IL2-IFNg+IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD4+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples
HBc CD4+CD40L-IL2-IFNg+IL17-
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0085
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0095
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD4+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples
HBc CD4+CD40L-IL2+IFNg-IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD4+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples
HBc CD4+CD40L-IL2+IFNg-IL17-
|
0.0161 Treg cells/million cells
Interval 0.0001 to 0.0321
|
0.0104 Treg cells/million cells
Interval 0.0001 to 0.0522
|
0.0022 Treg cells/million cells
Interval 0.0001 to 0.0213
|
0.0083 Treg cells/million cells
Interval 0.0001 to 0.0348
|
|
Frequency of CD4+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples
HBc CD4+CD40L-IL2-IFNg-IL17+
|
0.0063 Treg cells/million cells
Interval 0.0001 to 0.0124
|
0.0012 Treg cells/million cells
Interval 0.0001 to 0.0057
|
0.0048 Treg cells/million cells
Interval 0.0001 to 0.0158
|
0.0039 Treg cells/million cells
Interval 0.0007 to 0.0139
|
SECONDARY outcome
Timeframe: At the time of the visit for each subject (i.e., Day 0)Population: The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.
The frequency was assessed based on the following range of markers: CD8, CD40L, IFNg, IL-2 and IL-17. Note: The precision of the measure (i.e., four decimals) of median and inter-quartile range is not sufficient to distinguish between the values median, lower and upper limits of inter-quartile range for some of the data presented within the table below (e.g., median=0.0001 and inter-quartile range=0.0001 to 0.0001).
Outcome measures
| Measure |
Immune Tolerant Patients Group
n=2 Participants
Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
|
HBeAg Positive Group
n=7 Participants
HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
|
Inactive Carriers Group
n=40 Participants
Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
|
HBeAg Negative Group
n=11 Participants
HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
|
|---|---|---|---|---|
|
Frequency of CD8+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples
HBc CD8+CD40L+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0556 Treg cells/million cells
Interval 0.0001 to 0.1472
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0265
|
0.0035 Treg cells/million cells
Interval 0.0001 to 0.0193
|
|
Frequency of CD8+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples
HBc CD8+IFNg+
|
0.0246 Treg cells/million cells
Interval 0.0127 to 0.0365
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0239
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0248
|
0.0002 Treg cells/million cells
Interval 0.0001 to 0.023
|
|
Frequency of CD8+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples
HBc CD8+IL2+
|
0.0448 Treg cells/million cells
Interval 0.0078 to 0.0819
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0195
|
0.0004 Treg cells/million cells
Interval 0.0001 to 0.015
|
0.0042 Treg cells/million cells
Interval 0.0001 to 0.0105
|
|
Frequency of CD8+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples
HBc CD8+IL17+
|
0.1191 Treg cells/million cells
Interval 0.0001 to 0.238
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0768
|
0.0058 Treg cells/million cells
Interval 0.0001 to 0.0716
|
0.0075 Treg cells/million cells
Interval 0.0001 to 0.15
|
|
Frequency of CD8+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples
HBc CD8+CD40L+IL2+IFNg+IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD8+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples
HBc CD8+CD40L+IL2+IFNg+IL17-
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD8+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples
HBc CD8+CD40L+IL2-IFNg+IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD8+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples
HBc CD8+CD40L+IL2-IFNg+IL17-
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD8+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples
HBc CD8+CD40L+IL2+IFNg-IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD8+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples
HBc CD8+CD40L+IL2+IFNg-IL17-
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD8+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples
HBc CD8+CD40L+IL2-IFNg-IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD8+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples
HBc CD8+CD40L+IL2-IFNg-IL17-
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0556 Treg cells/million cells
Interval 0.0001 to 0.1554
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0277
|
0.0035 Treg cells/million cells
Interval 0.0001 to 0.0193
|
|
Frequency of CD8+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples
HBc CD8+CD40L-IL2+IFNg+IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD8+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples
HBc CD8+CD40L-IL2+IFNg+IL17-
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0011
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0012
|
|
Frequency of CD8+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples
HBc CD8+CD40L-IL2-IFNg+IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD8+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples
HBc CD8+CD40L-IL2-IFNg+IL17-
|
0.0246 Treg cells/million cells
Interval 0.0127 to 0.0365
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0227
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0217
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.023
|
|
Frequency of CD8+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples
HBc CD8+CD40L-IL2+IFNg-IL17+
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0001
|
|
Frequency of CD8+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples
HBc CD8+CD40L-IL2+IFNg-IL17-
|
0.0448 Treg cells/million cells
Interval 0.0078 to 0.0819
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0109
|
0.0053 Treg cells/million cells
Interval 0.0001 to 0.0153
|
0.0002 Treg cells/million cells
Interval 0.0001 to 0.0088
|
|
Frequency of CD8+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples
HBc CD8+CD40L-IL2-IFNg-IL17+
|
0.1166 Treg cells/million cells
Interval 0.0001 to 0.233
|
0.0001 Treg cells/million cells
Interval 0.0001 to 0.0768
|
0.0058 Treg cells/million cells
Interval 0.0001 to 0.0761
|
0.0075 Treg cells/million cells
Interval 0.0001 to 0.152
|
Adverse Events
Immune Tolerant Patients Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HBeAg Positive Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Inactive Carriers Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HBeAg Negative Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
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