Trial Outcomes & Findings for Development of Read-outs in Healthy, Hepatitis B Virus Naive Adults Vaccinated With the Hepatitis B Surface Antigen (HBsAg) in Combination With a GlaxoSmithKline (GSK) Biologicals' Adjuvant System (NCT NCT01777295)
NCT ID: NCT01777295
Last Updated: 2019-01-04
Results Overview
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
81 participants
Primary outcome timeframe
At Day -30 prior to placebo administration
Results posted on
2019-01-04
Participant Flow
Participant milestones
| Measure |
HBsAg/AS_1+2 Group
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30; or during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1+2 Group
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180; or during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
41
|
|
Overall Study
COMPLETED
|
36
|
38
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
HBsAg/AS_1+2 Group
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30; or during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1+2 Group
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180; or during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Pregnancy
|
0
|
1
|
|
Overall Study
Personal problem
|
1
|
0
|
|
Overall Study
Investigator call for AEs check
|
1
|
0
|
Baseline Characteristics
Development of Read-outs in Healthy, Hepatitis B Virus Naive Adults Vaccinated With the Hepatitis B Surface Antigen (HBsAg) in Combination With a GlaxoSmithKline (GSK) Biologicals' Adjuvant System
Baseline characteristics by cohort
| Measure |
HBsAg/AS_1+2 Group
n=40 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30; and during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1+2 Group
n=41 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180; and during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.2 Years
STANDARD_DEVIATION 4.1 • n=5 Participants
|
37.5 Years
STANDARD_DEVIATION 5.9 • n=7 Participants
|
38.4 Years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · African Heritage / African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · White - Arabic / North African Heritage
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · White - Caucasian / European Heritage
|
38 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Day -30 prior to placebo administrationPopulation: Analyses were performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=26 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Concentrations of Cytokines and Chemokines - Step 1
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines and Chemokines - Step 1
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines and Chemokines - Step 1
IL-6r
|
26000 pg/mL
Interval 20000.0 to 30000.0
|
22500 pg/mL
Interval 22000.0 to 30000.0
|
|
Concentrations of Cytokines and Chemokines - Step 1
IL-8
|
5.7 pg/mL
Interval 4.2 to 6.6
|
5.1 pg/mL
Interval 3.9 to 5.9
|
|
Concentrations of Cytokines and Chemokines - Step 1
IP-10
|
225 pg/mL
Interval 176.0 to 402.0
|
247.5 pg/mL
Interval 195.0 to 280.0
|
|
Concentrations of Cytokines and Chemokines - Step 1
MCP-1
|
107 pg/mL
Interval 89.0 to 142.0
|
98.5 pg/mL
Interval 83.0 to 117.0
|
|
Concentrations of Cytokines and Chemokines - Step 1
MCP-2
|
18 pg/mL
Interval 13.0 to 25.0
|
19.5 pg/mL
Interval 17.0 to 26.0
|
|
Concentrations of Cytokines and Chemokines - Step 1
MIP-3 alpha
|
25 pg/mL
Interval 11.0 to 32.0
|
18 pg/mL
Interval 11.0 to 28.0
|
|
Concentrations of Cytokines and Chemokines - Step 1
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Concentrations of Cytokines and Chemokines - Step 1
E-selectin
|
6000 pg/mL
Interval 4600.0 to 8300.0
|
6250 pg/mL
Interval 4600.0 to 7800.0
|
|
Concentrations of Cytokines and Chemokines - Step 1
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Concentrations of Cytokines and Chemokines - Step 1
IL-10
|
3.3 pg/mL
Interval 3.3 to 4.5
|
3.3 pg/mL
Interval 3.3 to 4.1
|
|
Concentrations of Cytokines and Chemokines - Step 1
IL-18
|
198 pg/mL
Interval 148.0 to 290.0
|
177 pg/mL
Interval 152.0 to 215.0
|
|
Concentrations of Cytokines and Chemokines - Step 1
IL-2
|
5.9 pg/mL
Interval 5.9 to 7.0
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Concentrations of Cytokines and Chemokines - Step 1
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Concentrations of Cytokines and Chemokines - Step 1
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Concentrations of Cytokines and Chemokines - Step 1
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines and Chemokines - Step 1
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Concentrations of Cytokines and Chemokines - Step 1
MCP-4
|
1230 pg/mL
Interval 1070.0 to 1550.0
|
1170 pg/mL
Interval 1100.0 to 1600.0
|
|
Concentrations of Cytokines and Chemokines - Step 1
MIG
|
513 pg/mL
Interval 354.0 to 682.0
|
435 pg/mL
Interval 285.0 to 674.0
|
|
Concentrations of Cytokines and Chemokines - Step 1
MIP-1 alpha
|
20 pg/mL
Interval 18.0 to 25.0
|
20 pg/mL
Interval 18.0 to 24.0
|
|
Concentrations of Cytokines and Chemokines - Step 1
MIP-1 beta
|
190 pg/mL
Interval 162.0 to 228.0
|
138 pg/mL
Interval 126.0 to 205.0
|
|
Concentrations of Cytokines and Chemokines - Step 1
MPIF-1
|
1600 pg/mL
Interval 1200.0 to 1800.0
|
1450 pg/mL
Interval 1200.0 to 1600.0
|
|
Concentrations of Cytokines and Chemokines - Step 1
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: Post-placebo at Day -30 plus 1.5 HoursPopulation: Analyses were performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=26 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Cytokines and Chemokines Concentrations - Step 1
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Cytokines and Chemokines Concentrations - Step 1
E-selectin
|
5900 pg/mL
Interval 4100.0 to 8500.0
|
6450 pg/mL
Interval 4500.0 to 7600.0
|
|
Cytokines and Chemokines Concentrations - Step 1
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Cytokines and Chemokines Concentrations - Step 1
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines and Chemokines Concentrations - Step 1
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.7
|
3.3 pg/mL
Interval 3.3 to 3.7
|
|
Cytokines and Chemokines Concentrations - Step 1
IL-18
|
172 pg/mL
Interval 141.0 to 225.0
|
179.5 pg/mL
Interval 136.0 to 215.0
|
|
Cytokines and Chemokines Concentrations - Step 1
IL-2
|
5.9 pg/mL
Interval 5.9 to 7.0
|
5.9 pg/mL
Interval 5.9 to 6.3
|
|
Cytokines and Chemokines Concentrations - Step 1
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines and Chemokines Concentrations - Step 1
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Cytokines and Chemokines Concentrations - Step 1
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Cytokines and Chemokines Concentrations - Step 1
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines and Chemokines Concentrations - Step 1
IL-6r
|
26000 pg/mL
Interval 21000.0 to 30000.0
|
22000 pg/mL
Interval 19000.0 to 29000.0
|
|
Cytokines and Chemokines Concentrations - Step 1
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Cytokines and Chemokines Concentrations - Step 1
IL-8
|
4.2 pg/mL
Interval 3.7 to 4.9
|
4.2 pg/mL
Interval 3.2 to 5.3
|
|
Cytokines and Chemokines Concentrations - Step 1
IP-10
|
220 pg/mL
Interval 183.0 to 330.0
|
207 pg/mL
Interval 172.0 to 240.0
|
|
Cytokines and Chemokines Concentrations - Step 1
MCP-1
|
79 pg/mL
Interval 58.0 to 101.0
|
77.5 pg/mL
Interval 63.0 to 96.0
|
|
Cytokines and Chemokines Concentrations - Step 1
MCP-2
|
17 pg/mL
Interval 13.0 to 24.0
|
19 pg/mL
Interval 14.0 to 25.0
|
|
Cytokines and Chemokines Concentrations - Step 1
MCP-4
|
1300 pg/mL
Interval 933.0 to 1480.0
|
1190 pg/mL
Interval 896.0 to 1300.0
|
|
Cytokines and Chemokines Concentrations - Step 1
MIG
|
392 pg/mL
Interval 344.0 to 575.0
|
336 pg/mL
Interval 269.0 to 487.0
|
|
Cytokines and Chemokines Concentrations - Step 1
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 21.0
|
18 pg/mL
Interval 18.0 to 19.0
|
|
Cytokines and Chemokines Concentrations - Step 1
MIP-1 beta
|
141 pg/mL
Interval 108.0 to 191.0
|
124.5 pg/mL
Interval 107.0 to 151.0
|
|
Cytokines and Chemokines Concentrations - Step 1
MIP-3 alpha
|
16 pg/mL
Interval 13.0 to 27.0
|
16 pg/mL
Interval 13.0 to 22.0
|
|
Cytokines and Chemokines Concentrations - Step 1
MPIF-1
|
1500 pg/mL
Interval 1200.0 to 1600.0
|
1400 pg/mL
Interval 1000.0 to 1600.0
|
|
Cytokines and Chemokines Concentrations - Step 1
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: Post-placebo at Day -30 plus 3 HoursPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=26 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Concentrations of Cytokines and Chemokines in Step 1
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines and Chemokines in Step 1
IL-18
|
168 pg/mL
Interval 154.0 to 283.0
|
173 pg/mL
Interval 142.0 to 202.0
|
|
Concentrations of Cytokines and Chemokines in Step 1
E-selectin
|
5600 pg/mL
Interval 3800.0 to 7800.0
|
6300 pg/mL
Interval 4100.0 to 7600.0
|
|
Concentrations of Cytokines and Chemokines in Step 1
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Concentrations of Cytokines and Chemokines in Step 1
IL-10
|
3.3 pg/mL
Interval 3.3 to 4.2
|
3.3 pg/mL
Interval 3.3 to 3.4
|
|
Concentrations of Cytokines and Chemokines in Step 1
IL-2
|
5.9 pg/mL
Interval 5.9 to 7.4
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Concentrations of Cytokines and Chemokines in Step 1
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines and Chemokines in Step 1
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Concentrations of Cytokines and Chemokines in Step 1
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Concentrations of Cytokines and Chemokines in Step 1
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines and Chemokines in Step 1
IL-6r
|
28000 pg/mL
Interval 22000.0 to 34000.0
|
26000 pg/mL
Interval 21000.0 to 33000.0
|
|
Concentrations of Cytokines and Chemokines in Step 1
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Concentrations of Cytokines and Chemokines in Step 1
IL-8
|
4.2 pg/mL
Interval 3.5 to 6.4
|
4 pg/mL
Interval 3.2 to 5.3
|
|
Concentrations of Cytokines and Chemokines in Step 1
IP-10
|
223 pg/mL
Interval 169.0 to 396.0
|
217.5 pg/mL
Interval 175.0 to 251.0
|
|
Concentrations of Cytokines and Chemokines in Step 1
MCP-1
|
79 pg/mL
Interval 65.0 to 92.0
|
64 pg/mL
Interval 48.0 to 104.0
|
|
Concentrations of Cytokines and Chemokines in Step 1
MCP-2
|
21 pg/mL
Interval 14.0 to 27.0
|
20 pg/mL
Interval 18.0 to 23.0
|
|
Concentrations of Cytokines and Chemokines in Step 1
MCP-4
|
1170 pg/mL
Interval 951.0 to 1440.0
|
1175 pg/mL
Interval 1060.0 to 1310.0
|
|
Concentrations of Cytokines and Chemokines in Step 1
MIG
|
439 pg/mL
Interval 347.0 to 558.0
|
343 pg/mL
Interval 285.0 to 504.0
|
|
Concentrations of Cytokines and Chemokines in Step 1
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 21.0
|
18 pg/mL
Interval 18.0 to 21.0
|
|
Concentrations of Cytokines and Chemokines in Step 1
MIP-1 beta
|
163 pg/mL
Interval 120.0 to 199.0
|
127 pg/mL
Interval 112.0 to 147.0
|
|
Concentrations of Cytokines and Chemokines in Step 1
MIP-3 alpha
|
18 pg/mL
Interval 12.0 to 27.0
|
18 pg/mL
Interval 14.0 to 22.0
|
|
Concentrations of Cytokines and Chemokines in Step 1
MPIF-1
|
1600 pg/mL
Interval 1200.0 to 1900.0
|
1300 pg/mL
Interval 1000.0 to 1500.0
|
|
Concentrations of Cytokines and Chemokines in Step 1
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Concentrations of Cytokines and Chemokines in Step 1
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: Post-placebo at Day -30 plus 6 HoursPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=26 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Concentrations of Cytokines and Chemokines During Step 1
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Concentrations of Cytokines and Chemokines During Step 1
IL-18
|
176 pg/mL
Interval 160.0 to 273.0
|
177.5 pg/mL
Interval 132.0 to 233.0
|
|
Concentrations of Cytokines and Chemokines During Step 1
E-selectin
|
5200 pg/mL
Interval 3900.0 to 8300.0
|
6050 pg/mL
Interval 4200.0 to 8100.0
|
|
Concentrations of Cytokines and Chemokines During Step 1
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines and Chemokines During Step 1
IL-10
|
3.3 pg/mL
Interval 3.3 to 4.6
|
3.3 pg/mL
Interval 3.3 to 3.6
|
|
Concentrations of Cytokines and Chemokines During Step 1
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
5.9 pg/mL
Interval 5.9 to 6.0
|
|
Concentrations of Cytokines and Chemokines During Step 1
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines and Chemokines During Step 1
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Concentrations of Cytokines and Chemokines During Step 1
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Concentrations of Cytokines and Chemokines During Step 1
IL-6
|
1.6 pg/mL
Interval 1.6 to 2.0
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines and Chemokines During Step 1
IL-6r
|
27000 pg/mL
Interval 21000.0 to 32000.0
|
24500 pg/mL
Interval 20000.0 to 33000.0
|
|
Concentrations of Cytokines and Chemokines During Step 1
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Concentrations of Cytokines and Chemokines During Step 1
IL-8
|
4.5 pg/mL
Interval 3.7 to 6.0
|
4.5 pg/mL
Interval 3.9 to 5.8
|
|
Concentrations of Cytokines and Chemokines During Step 1
IP-10
|
217 pg/mL
Interval 177.0 to 400.0
|
218 pg/mL
Interval 174.0 to 252.0
|
|
Concentrations of Cytokines and Chemokines During Step 1
MCP-1
|
104 pg/mL
Interval 76.0 to 119.0
|
101 pg/mL
Interval 76.0 to 129.0
|
|
Concentrations of Cytokines and Chemokines During Step 1
MCP-2
|
18 pg/mL
Interval 14.0 to 24.0
|
20.5 pg/mL
Interval 16.0 to 23.0
|
|
Concentrations of Cytokines and Chemokines During Step 1
MCP-4
|
1310 pg/mL
Interval 1030.0 to 1570.0
|
1245 pg/mL
Interval 1110.0 to 1490.0
|
|
Concentrations of Cytokines and Chemokines During Step 1
MIG
|
500 pg/mL
Interval 320.0 to 614.0
|
378 pg/mL
Interval 313.0 to 566.0
|
|
Concentrations of Cytokines and Chemokines During Step 1
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 21.0
|
18 pg/mL
Interval 18.0 to 19.0
|
|
Concentrations of Cytokines and Chemokines During Step 1
MIP-1 beta
|
166 pg/mL
Interval 140.0 to 215.0
|
146 pg/mL
Interval 129.0 to 180.0
|
|
Concentrations of Cytokines and Chemokines During Step 1
MIP-3 alpha
|
21 pg/mL
Interval 15.0 to 26.0
|
20 pg/mL
Interval 15.0 to 24.0
|
|
Concentrations of Cytokines and Chemokines During Step 1
MPIF-1
|
1500 pg/mL
Interval 1200.0 to 1800.0
|
1400 pg/mL
Interval 1100.0 to 1700.0
|
|
Concentrations of Cytokines and Chemokines During Step 1
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Concentrations of Cytokines and Chemokines During Step 1
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: Post-placebo at Day -30 plus 9 HoursPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=26 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Concentrations of Cytokines/Chemokines - Step 1
MCP-1
|
86 pg/mL
Interval 65.0 to 104.0
|
81 pg/mL
Interval 61.0 to 109.0
|
|
Concentrations of Cytokines/Chemokines - Step 1
MIP-1 beta
|
131 pg/mL
Interval 111.0 to 185.0
|
119.5 pg/mL
Interval 102.0 to 134.0
|
|
Concentrations of Cytokines/Chemokines - Step 1
MIP-3 alpha
|
19 pg/mL
Interval 11.0 to 25.0
|
15 pg/mL
Interval 11.0 to 17.0
|
|
Concentrations of Cytokines/Chemokines - Step 1
E-selectin
|
5300 pg/mL
Interval 3600.0 to 7100.0
|
6100 pg/mL
Interval 4600.0 to 7500.0
|
|
Concentrations of Cytokines/Chemokines - Step 1
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Concentrations of Cytokines/Chemokines - Step 1
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines/Chemokines - Step 1
IL-10
|
3.3 pg/mL
Interval 3.3 to 4.8
|
3.3 pg/mL
Interval 3.3 to 3.3
|
|
Concentrations of Cytokines/Chemokines - Step 1
IL-18
|
173 pg/mL
Interval 139.0 to 226.0
|
167.5 pg/mL
Interval 117.0 to 202.0
|
|
Concentrations of Cytokines/Chemokines - Step 1
IL-2
|
5.9 pg/mL
Interval 5.9 to 14.0
|
5.9 pg/mL
Interval 5.9 to 7.2
|
|
Concentrations of Cytokines/Chemokines - Step 1
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines/Chemokines - Step 1
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Concentrations of Cytokines/Chemokines - Step 1
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Concentrations of Cytokines/Chemokines - Step 1
IL-6
|
1.6 pg/mL
Interval 1.6 to 2.7
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines/Chemokines - Step 1
IL-6r
|
24000 pg/mL
Interval 19000.0 to 31000.0
|
26000 pg/mL
Interval 19000.0 to 29000.0
|
|
Concentrations of Cytokines/Chemokines - Step 1
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Concentrations of Cytokines/Chemokines - Step 1
IL-8
|
4.9 pg/mL
Interval 3.7 to 6.9
|
4.5 pg/mL
Interval 3.6 to 5.3
|
|
Concentrations of Cytokines/Chemokines - Step 1
IP-10
|
210 pg/mL
Interval 162.0 to 327.0
|
205.5 pg/mL
Interval 159.0 to 227.0
|
|
Concentrations of Cytokines/Chemokines - Step 1
MCP-2
|
17 pg/mL
Interval 15.0 to 24.0
|
17 pg/mL
Interval 15.0 to 21.0
|
|
Concentrations of Cytokines/Chemokines - Step 1
MCP-4
|
1310 pg/mL
Interval 1050.0 to 1610.0
|
1145 pg/mL
Interval 944.0 to 1400.0
|
|
Concentrations of Cytokines/Chemokines - Step 1
MIG
|
452 pg/mL
Interval 313.0 to 610.0
|
327 pg/mL
Interval 244.0 to 528.0
|
|
Concentrations of Cytokines/Chemokines - Step 1
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 22.0
|
18 pg/mL
Interval 18.0 to 18.0
|
|
Concentrations of Cytokines/Chemokines - Step 1
MPIF-1
|
1400 pg/mL
Interval 1100.0 to 1800.0
|
1200 pg/mL
Interval 1000.0 to 1400.0
|
|
Concentrations of Cytokines/Chemokines - Step 1
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Concentrations of Cytokines/Chemokines - Step 1
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: Post-placebo at Day -30 plus 12 HoursPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=25 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Concentrations of Cytokines/Chemokines in Step 1
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines/Chemokines in Step 1
MCP-2
|
18 pg/mL
Interval 14.0 to 26.0
|
19 pg/mL
Interval 17.0 to 25.0
|
|
Concentrations of Cytokines/Chemokines in Step 1
MPIF-1
|
1400 pg/mL
Interval 1200.0 to 1700.0
|
1300 pg/mL
Interval 1000.0 to 1500.0
|
|
Concentrations of Cytokines/Chemokines in Step 1
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Concentrations of Cytokines/Chemokines in Step 1
E-selectin
|
5200 pg/mL
Interval 3500.0 to 7900.0
|
5600 pg/mL
Interval 4000.0 to 7800.0
|
|
Concentrations of Cytokines/Chemokines in Step 1
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Concentrations of Cytokines/Chemokines in Step 1
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.3
|
3.3 pg/mL
Interval 3.3 to 3.3
|
|
Concentrations of Cytokines/Chemokines in Step 1
IL-18
|
171 pg/mL
Interval 150.0 to 244.0
|
180 pg/mL
Interval 131.0 to 222.0
|
|
Concentrations of Cytokines/Chemokines in Step 1
IL-2
|
5.9 pg/mL
Interval 5.9 to 6.3
|
5.9 pg/mL
Interval 5.9 to 6.3
|
|
Concentrations of Cytokines/Chemokines in Step 1
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines/Chemokines in Step 1
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Concentrations of Cytokines/Chemokines in Step 1
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Concentrations of Cytokines/Chemokines in Step 1
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines/Chemokines in Step 1
IL-6r
|
26000 pg/mL
Interval 21000.0 to 32000.0
|
24000 pg/mL
Interval 21000.0 to 34000.0
|
|
Concentrations of Cytokines/Chemokines in Step 1
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Concentrations of Cytokines/Chemokines in Step 1
IL-8
|
4.6 pg/mL
Interval 3.9 to 5.9
|
4.5 pg/mL
Interval 3.9 to 5.8
|
|
Concentrations of Cytokines/Chemokines in Step 1
IP-10
|
217 pg/mL
Interval 160.0 to 335.0
|
214 pg/mL
Interval 182.0 to 246.0
|
|
Concentrations of Cytokines/Chemokines in Step 1
MCP-1
|
117 pg/mL
Interval 79.0 to 133.0
|
120 pg/mL
Interval 96.0 to 137.0
|
|
Concentrations of Cytokines/Chemokines in Step 1
MCP-4
|
1260 pg/mL
Interval 1000.0 to 1480.0
|
1160 pg/mL
Interval 997.0 to 1480.0
|
|
Concentrations of Cytokines/Chemokines in Step 1
MIG
|
460 pg/mL
Interval 344.0 to 623.0
|
412 pg/mL
Interval 341.0 to 564.0
|
|
Concentrations of Cytokines/Chemokines in Step 1
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 21.0
|
18 pg/mL
Interval 18.0 to 21.0
|
|
Concentrations of Cytokines/Chemokines in Step 1
MIP-1 beta
|
159 pg/mL
Interval 120.0 to 179.0
|
137 pg/mL
Interval 118.0 to 167.0
|
|
Concentrations of Cytokines/Chemokines in Step 1
MIP-3 alpha
|
21 pg/mL
Interval 14.0 to 26.0
|
22 pg/mL
Interval 17.0 to 28.0
|
|
Concentrations of Cytokines/Chemokines in Step 1
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: Post-placebo at Day -30 plus 18 HoursPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=14 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Concentrations of Cytokines/Chemokines During Step 1
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Concentrations of Cytokines/Chemokines During Step 1
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.6
|
3.3 pg/mL
Interval 3.3 to 3.3
|
|
Concentrations of Cytokines/Chemokines During Step 1
IL-18
|
174 pg/mL
Interval 118.0 to 267.0
|
142 pg/mL
Interval 81.0 to 182.0
|
|
Concentrations of Cytokines/Chemokines During Step 1
IP-10
|
243.5 pg/mL
Interval 174.0 to 386.0
|
238 pg/mL
Interval 170.0 to 483.0
|
|
Concentrations of Cytokines/Chemokines During Step 1
MIP-1 beta
|
143.5 pg/mL
Interval 136.0 to 182.0
|
165 pg/mL
Interval 128.0 to 216.0
|
|
Concentrations of Cytokines/Chemokines During Step 1
E-selectin
|
4950 pg/mL
Interval 2900.0 to 6500.0
|
4200 pg/mL
Interval 2700.0 to 6300.0
|
|
Concentrations of Cytokines/Chemokines During Step 1
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines/Chemokines During Step 1
IL-2
|
6 pg/mL
Interval 5.9 to 6.3
|
5.9 pg/mL
Interval 5.9 to 6.0
|
|
Concentrations of Cytokines/Chemokines During Step 1
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines/Chemokines During Step 1
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Concentrations of Cytokines/Chemokines During Step 1
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Concentrations of Cytokines/Chemokines During Step 1
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 2.4
|
|
Concentrations of Cytokines/Chemokines During Step 1
IL-6r
|
21500 pg/mL
Interval 18000.0 to 29000.0
|
21000 pg/mL
Interval 18000.0 to 28000.0
|
|
Concentrations of Cytokines/Chemokines During Step 1
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Concentrations of Cytokines/Chemokines During Step 1
IL-8
|
5.5 pg/mL
Interval 4.6 to 8.2
|
6.1 pg/mL
Interval 4.9 to 7.8
|
|
Concentrations of Cytokines/Chemokines During Step 1
MCP-1
|
98 pg/mL
Interval 76.0 to 119.0
|
109 pg/mL
Interval 79.0 to 132.0
|
|
Concentrations of Cytokines/Chemokines During Step 1
MCP-2
|
18 pg/mL
Interval 12.0 to 26.0
|
17 pg/mL
Interval 16.0 to 27.0
|
|
Concentrations of Cytokines/Chemokines During Step 1
MCP-4
|
1445 pg/mL
Interval 1130.0 to 1640.0
|
1390 pg/mL
Interval 1140.0 to 1710.0
|
|
Concentrations of Cytokines/Chemokines During Step 1
MIG
|
420 pg/mL
Interval 373.0 to 636.0
|
458 pg/mL
Interval 340.0 to 811.0
|
|
Concentrations of Cytokines/Chemokines During Step 1
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 26.0
|
18 pg/mL
Interval 18.0 to 23.0
|
|
Concentrations of Cytokines/Chemokines During Step 1
MIP-3 alpha
|
30 pg/mL
Interval 21.0 to 34.0
|
20 pg/mL
Interval 17.0 to 38.0
|
|
Concentrations of Cytokines/Chemokines During Step 1
MPIF-1
|
1400 pg/mL
Interval 1300.0 to 1700.0
|
1100 pg/mL
Interval 920.0 to 1500.0
|
|
Concentrations of Cytokines/Chemokines During Step 1
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Concentrations of Cytokines/Chemokines During Step 1
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: Post-placebo at Day -29Population: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=26 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Cytokines and Chemokines Concentrations in Step 1
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Cytokines and Chemokines Concentrations in Step 1
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Cytokines and Chemokines Concentrations in Step 1
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.7
|
1.6 pg/mL
Interval 1.6 to 1.7
|
|
Cytokines and Chemokines Concentrations in Step 1
IP-10
|
241 pg/mL
Interval 190.0 to 345.0
|
244.5 pg/mL
Interval 200.0 to 307.0
|
|
Cytokines and Chemokines Concentrations in Step 1
MIP-3 alpha
|
22 pg/mL
Interval 17.0 to 28.0
|
21 pg/mL
Interval 14.0 to 28.0
|
|
Cytokines and Chemokines Concentrations in Step 1
MPIF-1
|
1700 pg/mL
Interval 1200.0 to 1900.0
|
1500 pg/mL
Interval 1100.0 to 1700.0
|
|
Cytokines and Chemokines Concentrations in Step 1
E-selectin
|
5900 pg/mL
Interval 4300.0 to 8500.0
|
6350 pg/mL
Interval 4500.0 to 8600.0
|
|
Cytokines and Chemokines Concentrations in Step 1
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines and Chemokines Concentrations in Step 1
IL-10
|
3.3 pg/mL
Interval 3.3 to 4.5
|
3.3 pg/mL
Interval 3.3 to 3.3
|
|
Cytokines and Chemokines Concentrations in Step 1
IL-18
|
186 pg/mL
Interval 149.0 to 261.0
|
177.5 pg/mL
Interval 136.0 to 242.0
|
|
Cytokines and Chemokines Concentrations in Step 1
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Cytokines and Chemokines Concentrations in Step 1
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines and Chemokines Concentrations in Step 1
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Cytokines and Chemokines Concentrations in Step 1
IL-6r
|
27000 pg/mL
Interval 19000.0 to 35000.0
|
26500 pg/mL
Interval 19000.0 to 31000.0
|
|
Cytokines and Chemokines Concentrations in Step 1
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Cytokines and Chemokines Concentrations in Step 1
IL-8
|
5.4 pg/mL
Interval 3.9 to 6.9
|
5.2 pg/mL
Interval 4.3 to 6.8
|
|
Cytokines and Chemokines Concentrations in Step 1
MCP-1
|
93 pg/mL
Interval 73.0 to 116.0
|
81.5 pg/mL
Interval 66.0 to 104.0
|
|
Cytokines and Chemokines Concentrations in Step 1
MCP-2
|
19 pg/mL
Interval 15.0 to 24.0
|
19 pg/mL
Interval 16.0 to 25.0
|
|
Cytokines and Chemokines Concentrations in Step 1
MCP-4
|
1230 pg/mL
Interval 1070.0 to 1350.0
|
1170 pg/mL
Interval 1020.0 to 1450.0
|
|
Cytokines and Chemokines Concentrations in Step 1
MIG
|
528 pg/mL
Interval 327.0 to 695.0
|
418.5 pg/mL
Interval 352.0 to 721.0
|
|
Cytokines and Chemokines Concentrations in Step 1
MIP-1 alpha
|
19 pg/mL
Interval 18.0 to 24.0
|
18 pg/mL
Interval 18.0 to 21.0
|
|
Cytokines and Chemokines Concentrations in Step 1
MIP-1 beta
|
169 pg/mL
Interval 124.0 to 219.0
|
141.5 pg/mL
Interval 123.0 to 188.0
|
|
Cytokines and Chemokines Concentrations in Step 1
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Cytokines and Chemokines Concentrations in Step 1
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: Post-placebo at Day -28Population: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=26 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Cytokines and Chemokines Concetrations During Step 1
E-selectin
|
5900 pg/mL
Interval 3700.0 to 7800.0
|
6250 pg/mL
Interval 4300.0 to 7900.0
|
|
Cytokines and Chemokines Concetrations During Step 1
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Cytokines and Chemokines Concetrations During Step 1
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.9
|
3.3 pg/mL
Interval 3.3 to 3.9
|
|
Cytokines and Chemokines Concetrations During Step 1
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Cytokines and Chemokines Concetrations During Step 1
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Cytokines and Chemokines Concetrations During Step 1
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
|
Cytokines and Chemokines Concetrations During Step 1
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines and Chemokines Concetrations During Step 1
IL-18
|
182 pg/mL
Interval 148.0 to 288.0
|
178.5 pg/mL
Interval 120.0 to 232.0
|
|
Cytokines and Chemokines Concetrations During Step 1
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Cytokines and Chemokines Concetrations During Step 1
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines and Chemokines Concetrations During Step 1
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Cytokines and Chemokines Concetrations During Step 1
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines and Chemokines Concetrations During Step 1
IL-6r
|
27000 pg/mL
Interval 20000.0 to 35000.0
|
25500 pg/mL
Interval 20000.0 to 28000.0
|
|
Cytokines and Chemokines Concetrations During Step 1
IL-8
|
4.8 pg/mL
Interval 3.7 to 6.5
|
4.9 pg/mL
Interval 3.5 to 6.6
|
|
Cytokines and Chemokines Concetrations During Step 1
IP-10
|
270 pg/mL
Interval 205.0 to 381.0
|
228 pg/mL
Interval 186.0 to 304.0
|
|
Cytokines and Chemokines Concetrations During Step 1
MCP-1
|
74 pg/mL
Interval 56.0 to 112.0
|
73.5 pg/mL
Interval 47.0 to 90.0
|
|
Cytokines and Chemokines Concetrations During Step 1
MCP-2
|
19 pg/mL
Interval 13.0 to 26.0
|
18.5 pg/mL
Interval 15.0 to 26.0
|
|
Cytokines and Chemokines Concetrations During Step 1
MCP-4
|
1200 pg/mL
Interval 937.0 to 1530.0
|
1140 pg/mL
Interval 951.0 to 1340.0
|
|
Cytokines and Chemokines Concetrations During Step 1
MIG
|
468 pg/mL
Interval 336.0 to 568.0
|
397 pg/mL
Interval 292.0 to 587.0
|
|
Cytokines and Chemokines Concetrations During Step 1
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 21.0
|
18 pg/mL
Interval 18.0 to 18.0
|
|
Cytokines and Chemokines Concetrations During Step 1
MIP-1 beta
|
174 pg/mL
Interval 141.0 to 227.0
|
151.5 pg/mL
Interval 113.0 to 175.0
|
|
Cytokines and Chemokines Concetrations During Step 1
MIP-3 alpha
|
20 pg/mL
Interval 15.0 to 28.0
|
17.5 pg/mL
Interval 11.0 to 33.0
|
|
Cytokines and Chemokines Concetrations During Step 1
MPIF-1
|
1500 pg/mL
Interval 1200.0 to 1800.0
|
1350 pg/mL
Interval 970.0 to 1600.0
|
|
Cytokines and Chemokines Concetrations During Step 1
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
PRIMARY outcome
Timeframe: Post-placebo at Day -27Population: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=26 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=26 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Cytokines/Chemokines Concentrations in Step 1
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines/Chemokines Concentrations in Step 1
IL-10
|
3.4 pg/mL
Interval 3.3 to 4.5
|
3.3 pg/mL
Interval 3.3 to 4.2
|
|
Cytokines/Chemokines Concentrations in Step 1
IL-8
|
4.3 pg/mL
Interval 3.4 to 6.6
|
4.2 pg/mL
Interval 3.6 to 5.4
|
|
Cytokines/Chemokines Concentrations in Step 1
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.7
|
1.6 pg/mL
Interval 1.6 to 1.7
|
|
Cytokines/Chemokines Concentrations in Step 1
IL-6r
|
26000 pg/mL
Interval 21000.0 to 32000.0
|
24000 pg/mL
Interval 21000.0 to 29000.0
|
|
Cytokines/Chemokines Concentrations in Step 1
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Cytokines/Chemokines Concentrations in Step 1
IP-10
|
239 pg/mL
Interval 189.0 to 348.0
|
220.5 pg/mL
Interval 186.0 to 281.0
|
|
Cytokines/Chemokines Concentrations in Step 1
MCP-1
|
84.5 pg/mL
Interval 65.0 to 110.0
|
86.5 pg/mL
Interval 73.0 to 109.0
|
|
Cytokines/Chemokines Concentrations in Step 1
MCP-2
|
18.5 pg/mL
Interval 14.0 to 22.0
|
20 pg/mL
Interval 15.0 to 25.0
|
|
Cytokines/Chemokines Concentrations in Step 1
MCP-4
|
1150 pg/mL
Interval 989.0 to 1270.0
|
1060 pg/mL
Interval 911.0 to 1360.0
|
|
Cytokines/Chemokines Concentrations in Step 1
MIG
|
429.5 pg/mL
Interval 349.0 to 542.0
|
403.5 pg/mL
Interval 300.0 to 635.0
|
|
Cytokines/Chemokines Concentrations in Step 1
MIP-1 beta
|
165 pg/mL
Interval 117.0 to 196.0
|
141 pg/mL
Interval 106.0 to 181.0
|
|
Cytokines/Chemokines Concentrations in Step 1
E-selectin
|
6150 pg/mL
Interval 3700.0 to 8200.0
|
6250 pg/mL
Interval 4000.0 to 7200.0
|
|
Cytokines/Chemokines Concentrations in Step 1
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Cytokines/Chemokines Concentrations in Step 1
IL-18
|
183 pg/mL
Interval 157.0 to 236.0
|
174.5 pg/mL
Interval 139.0 to 217.0
|
|
Cytokines/Chemokines Concentrations in Step 1
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Cytokines/Chemokines Concentrations in Step 1
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines/Chemokines Concentrations in Step 1
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Cytokines/Chemokines Concentrations in Step 1
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Cytokines/Chemokines Concentrations in Step 1
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 23.0
|
18 pg/mL
Interval 18.0 to 19.0
|
|
Cytokines/Chemokines Concentrations in Step 1
MIP-3 alpha
|
20.5 pg/mL
Interval 18.0 to 27.0
|
21 pg/mL
Interval 18.0 to 26.0
|
|
Cytokines/Chemokines Concentrations in Step 1
MPIF-1
|
1350 pg/mL
Interval 1200.0 to 1700.0
|
1300 pg/mL
Interval 1100.0 to 1600.0
|
|
Cytokines/Chemokines Concentrations in Step 1
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Cytokines/Chemokines Concentrations in Step 1
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: Post-placebo at Day -23Population: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=26 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Cytokines and Chemokines Concentrations During Step 1
E-selectin
|
5500 pg/mL
Interval 4000.0 to 8300.0
|
6150 pg/mL
Interval 4700.0 to 7900.0
|
|
Cytokines and Chemokines Concentrations During Step 1
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Cytokines and Chemokines Concentrations During Step 1
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines and Chemokines Concentrations During Step 1
IL-10
|
3.3 pg/mL
Interval 3.3 to 4.3
|
3.3 pg/mL
Interval 3.3 to 3.5
|
|
Cytokines and Chemokines Concentrations During Step 1
IL-2
|
5.9 pg/mL
Interval 5.9 to 7.0
|
5.9 pg/mL
Interval 5.9 to 7.0
|
|
Cytokines and Chemokines Concentrations During Step 1
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Cytokines and Chemokines Concentrations During Step 1
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Cytokines and Chemokines Concentrations During Step 1
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines and Chemokines Concentrations During Step 1
IL-6r
|
27000 pg/mL
Interval 17000.0 to 310000.0
|
23500 pg/mL
Interval 19000.0 to 28000.0
|
|
Cytokines and Chemokines Concentrations During Step 1
IL-8
|
4.5 pg/mL
Interval 3.9 to 6.8
|
5 pg/mL
Interval 3.5 to 5.8
|
|
Cytokines and Chemokines Concentrations During Step 1
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
|
Cytokines and Chemokines Concentrations During Step 1
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Cytokines and Chemokines Concentrations During Step 1
IP-10
|
241 pg/mL
Interval 190.0 to 366.0
|
223 pg/mL
Interval 186.0 to 285.0
|
|
Cytokines and Chemokines Concentrations During Step 1
MCP-1
|
88 pg/mL
Interval 55.0 to 143.0
|
72 pg/mL
Interval 66.0 to 96.0
|
|
Cytokines and Chemokines Concentrations During Step 1
MCP-2
|
15 pg/mL
Interval 14.0 to 25.0
|
19 pg/mL
Interval 16.0 to 23.0
|
|
Cytokines and Chemokines Concentrations During Step 1
MCP-4
|
1390 pg/mL
Interval 1000.0 to 1480.0
|
1145 pg/mL
Interval 1000.0 to 1350.0
|
|
Cytokines and Chemokines Concentrations During Step 1
MIG
|
391 pg/mL
Interval 337.0 to 524.0
|
375.5 pg/mL
Interval 286.0 to 625.0
|
|
Cytokines and Chemokines Concentrations During Step 1
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 22.0
|
18 pg/mL
Interval 18.0 to 19.0
|
|
Cytokines and Chemokines Concentrations During Step 1
MIP-1 beta
|
165 pg/mL
Interval 128.0 to 199.0
|
138.5 pg/mL
Interval 113.0 to 158.0
|
|
Cytokines and Chemokines Concentrations During Step 1
MIP-3 alpha
|
21 pg/mL
Interval 13.0 to 28.0
|
16 pg/mL
Interval 10.0 to 21.0
|
|
Cytokines and Chemokines Concentrations During Step 1
MPIF-1
|
1600 pg/mL
Interval 1200.0 to 1800.0
|
1350 pg/mL
Interval 1000.0 to 1700.0
|
|
Cytokines and Chemokines Concentrations During Step 1
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Cytokines and Chemokines Concentrations During Step 1
IL-18
|
184 pg/mL
Interval 150.0 to 247.0
|
176.5 pg/mL
Interval 122.0 to 208.0
|
|
Cytokines and Chemokines Concentrations During Step 1
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
PRIMARY outcome
Timeframe: Pre-dose1 at Day 0Population: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=26 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Concentrations of Cytokines and Chemokines - Study Step 1
MCP-2
|
18 pg/mL
Interval 14.0 to 22.0
|
19 pg/mL
Interval 16.0 to 28.0
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
E-selectin
|
6100 pg/mL
Interval 4200.0 to 9000.0
|
6150 pg/mL
Interval 5000.0 to 8600.0
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
IL-18
|
169 pg/mL
Interval 151.0 to 237.0
|
171 pg/mL
Interval 119.0 to 207.0
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
IL-8
|
4.9 pg/mL
Interval 4.2 to 6.2
|
5 pg/mL
Interval 4.2 to 7.4
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
IP-10
|
243 pg/mL
Interval 199.0 to 294.0
|
225 pg/mL
Interval 178.0 to 334.0
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
MCP-1
|
94 pg/mL
Interval 75.0 to 121.0
|
92.5 pg/mL
Interval 80.0 to 125.0
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
MIG
|
496 pg/mL
Interval 328.0 to 705.0
|
462.5 pg/mL
Interval 303.0 to 701.0
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
MPIF-1
|
1500 pg/mL
Interval 1300.0 to 1700.0
|
1300 pg/mL
Interval 1000.0 to 1500.0
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
IL-6r
|
27000 pg/mL
Interval 20000.0 to 32000.0
|
24500 pg/mL
Interval 22000.0 to 29000.0
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
MCP-4
|
1310 pg/mL
Interval 1110.0 to 1570.0
|
1260 pg/mL
Interval 1030.0 to 1520.0
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 23.0
|
18 pg/mL
Interval 18.0 to 19.0
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
MIP-1 beta
|
164 pg/mL
Interval 121.0 to 198.0
|
153 pg/mL
Interval 124.0 to 196.0
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
MIP-3 alpha
|
20 pg/mL
Interval 11.0 to 27.0
|
19.5 pg/mL
Interval 14.0 to 24.0
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
IL-2
|
5.9 pg/mL
Interval 5.9 to 6.5
|
5.9 pg/mL
Interval 5.9 to 6.5
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.5
|
3.3 pg/mL
Interval 3.3 to 3.9
|
PRIMARY outcome
Timeframe: Post-dose1 at Day 0 plus 1.5 HoursPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=25 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
E-selectin
|
5500 pg/mL
Interval 4000.0 to 8400.0
|
5900 pg/mL
Interval 4800.0 to 8100.0
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 22.0
|
18 pg/mL
Interval 18.0 to 19.0
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
MIP-1 beta
|
164 pg/mL
Interval 132.0 to 194.0
|
137 pg/mL
Interval 114.0 to 167.0
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
MIP-3 alpha
|
18 pg/mL
Interval 15.0 to 26.0
|
20 pg/mL
Interval 14.0 to 24.0
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
MPIF-1
|
1500 pg/mL
Interval 1300.0 to 1800.0
|
1200 pg/mL
Interval 970.0 to 1400.0
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.8
|
3.3 pg/mL
Interval 3.3 to 3.9
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
IL-18
|
168 pg/mL
Interval 144.0 to 220.0
|
168 pg/mL
Interval 126.0 to 208.0
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
5.9 pg/mL
Interval 5.9 to 7.4
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
IL-6r
|
26000 pg/mL
Interval 21000.0 to 32000.0
|
25000 pg/mL
Interval 19000.0 to 29000.0
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
IL-8
|
4.9 pg/mL
Interval 3.6 to 5.5
|
4.2 pg/mL
Interval 3.3 to 5.1
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
IP-10
|
224 pg/mL
Interval 198.0 to 318.0
|
226 pg/mL
Interval 186.0 to 265.0
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
MCP-1
|
74 pg/mL
Interval 56.0 to 97.0
|
75 pg/mL
Interval 56.0 to 108.0
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
MCP-2
|
18 pg/mL
Interval 14.0 to 23.0
|
20 pg/mL
Interval 16.0 to 22.0
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
MCP-4
|
1240 pg/mL
Interval 943.0 to 1520.0
|
1240 pg/mL
Interval 951.0 to 1340.0
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
MIG
|
423 pg/mL
Interval 385.0 to 535.0
|
378 pg/mL
Interval 308.0 to 522.0
|
PRIMARY outcome
Timeframe: Post-dose1 at Day 0 plus 6 HoursPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=26 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 21.0
|
18 pg/mL
Interval 18.0 to 19.0
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
E-selectin
|
5400 pg/mL
Interval 4100.0 to 7600.0
|
5900 pg/mL
Interval 4300.0 to 7600.0
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
IL-2
|
5.9 pg/mL
Interval 5.9 to 6.0
|
5.9 pg/mL
Interval 5.9 to 6.0
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.3
|
3.3 pg/mL
Interval 3.3 to 3.3
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
IL-18
|
170 pg/mL
Interval 130.0 to 225.0
|
169 pg/mL
Interval 110.0 to 220.0
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
IL-6
|
3.4 pg/mL
Interval 2.4 to 6.0
|
1.6 pg/mL
Interval 1.6 to 1.7
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
IL-6r
|
26000 pg/mL
Interval 20000.0 to 33000.0
|
25000 pg/mL
Interval 22000.0 to 30000.0
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
IL-8
|
4.6 pg/mL
Interval 3.9 to 5.5
|
4.6 pg/mL
Interval 3.9 to 7.2
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
IP-10
|
207 pg/mL
Interval 179.0 to 270.0
|
204 pg/mL
Interval 180.0 to 282.0
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
MCP-1
|
94 pg/mL
Interval 75.0 to 123.0
|
85 pg/mL
Interval 66.0 to 112.0
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
MCP-2
|
18 pg/mL
Interval 15.0 to 20.0
|
18.5 pg/mL
Interval 16.0 to 23.0
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
MIP-1 beta
|
165 pg/mL
Interval 129.0 to 181.0
|
141 pg/mL
Interval 111.0 to 174.0
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
MIP-3 alpha
|
19 pg/mL
Interval 15.0 to 28.0
|
18.5 pg/mL
Interval 12.0 to 23.0
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
MPIF-1
|
1400 pg/mL
Interval 1200.0 to 1600.0
|
1300 pg/mL
Interval 1000.0 to 1500.0
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
MCP-4
|
1130 pg/mL
Interval 912.0 to 1390.0
|
1130 pg/mL
Interval 989.0 to 1310.0
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
MIG
|
459 pg/mL
Interval 332.0 to 567.0
|
372.5 pg/mL
Interval 302.0 to 557.0
|
PRIMARY outcome
Timeframe: Post-dose1 at Day 0 plus 12 HoursPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=26 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Cytokines and Chemokines Concentrations - Study Step 1
MCP-4
|
1260 pg/mL
Interval 1000.0 to 1530.0
|
1265 pg/mL
Interval 1030.0 to 1520.0
|
|
Cytokines and Chemokines Concentrations - Study Step 1
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 21.0
|
18 pg/mL
Interval 18.0 to 19.0
|
|
Cytokines and Chemokines Concentrations - Study Step 1
MIP-1 beta
|
183 pg/mL
Interval 142.0 to 212.0
|
132 pg/mL
Interval 102.0 to 171.0
|
|
Cytokines and Chemokines Concentrations - Study Step 1
MIP-3 alpha
|
20 pg/mL
Interval 17.0 to 28.0
|
19.5 pg/mL
Interval 14.0 to 27.0
|
|
Cytokines and Chemokines Concentrations - Study Step 1
MPIF-1
|
1600 pg/mL
Interval 1200.0 to 1700.0
|
1300 pg/mL
Interval 1000.0 to 1700.0
|
|
Cytokines and Chemokines Concentrations - Study Step 1
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Cytokines and Chemokines Concentrations - Study Step 1
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
|
Cytokines and Chemokines Concentrations - Study Step 1
E-selectin
|
5900 pg/mL
Interval 4400.0 to 8800.0
|
6400 pg/mL
Interval 5000.0 to 8000.0
|
|
Cytokines and Chemokines Concentrations - Study Step 1
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Cytokines and Chemokines Concentrations - Study Step 1
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines and Chemokines Concentrations - Study Step 1
IL-10
|
3.9 pg/mL
Interval 3.3 to 5.5
|
3.3 pg/mL
Interval 3.3 to 3.3
|
|
Cytokines and Chemokines Concentrations - Study Step 1
IL-18
|
171 pg/mL
Interval 155.0 to 235.0
|
181.5 pg/mL
Interval 128.0 to 205.0
|
|
Cytokines and Chemokines Concentrations - Study Step 1
IL-2
|
5.9 pg/mL
Interval 5.9 to 6.5
|
5.9 pg/mL
Interval 5.9 to 6.0
|
|
Cytokines and Chemokines Concentrations - Study Step 1
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines and Chemokines Concentrations - Study Step 1
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Cytokines and Chemokines Concentrations - Study Step 1
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Cytokines and Chemokines Concentrations - Study Step 1
IL-6
|
6.3 pg/mL
Interval 3.9 to 8.2
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines and Chemokines Concentrations - Study Step 1
IL-6r
|
26000 pg/mL
Interval 21000.0 to 32000.0
|
24000 pg/mL
Interval 22000.0 to 33000.0
|
|
Cytokines and Chemokines Concentrations - Study Step 1
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Cytokines and Chemokines Concentrations - Study Step 1
IL-8
|
4.2 pg/mL
Interval 3.5 to 5.1
|
4.8 pg/mL
Interval 4.0 to 5.6
|
|
Cytokines and Chemokines Concentrations - Study Step 1
IP-10
|
236 pg/mL
Interval 197.0 to 281.0
|
194 pg/mL
Interval 167.0 to 282.0
|
|
Cytokines and Chemokines Concentrations - Study Step 1
MCP-1
|
111 pg/mL
Interval 87.0 to 137.0
|
111.5 pg/mL
Interval 84.0 to 129.0
|
|
Cytokines and Chemokines Concentrations - Study Step 1
MCP-2
|
19 pg/mL
Interval 15.0 to 27.0
|
19.5 pg/mL
Interval 15.0 to 25.0
|
|
Cytokines and Chemokines Concentrations - Study Step 1
MIG
|
478 pg/mL
Interval 361.0 to 614.0
|
410 pg/mL
Interval 296.0 to 588.0
|
PRIMARY outcome
Timeframe: Post-dose1 at Day 0 plus 18 HoursPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=14 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
MCP-1
|
111 pg/mL
Interval 91.0 to 130.0
|
115 pg/mL
Interval 98.0 to 130.0
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 20.0
|
18 pg/mL
Interval 18.0 to 18.0
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
MIP-1 beta
|
258 pg/mL
Interval 200.0 to 303.0
|
134 pg/mL
Interval 117.0 to 206.0
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
E-selectin
|
5750 pg/mL
Interval 3400.0 to 8000.0
|
4700 pg/mL
Interval 3500.0 to 5900.0
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
IFN-γ
|
1.8 pg/mL
Interval 1.6 to 2.4
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
IL-10
|
3.3 pg/mL
Interval 3.3 to 4.8
|
3.3 pg/mL
Interval 3.3 to 3.3
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
IL-18
|
180 pg/mL
Interval 155.0 to 217.0
|
126 pg/mL
Interval 93.0 to 168.0
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
IL-2
|
5.9 pg/mL
Interval 5.9 to 6.0
|
5.9 pg/mL
Interval 5.9 to 6.0
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
IL-6
|
4.5 pg/mL
Interval 3.1 to 6.9
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
IL-6r
|
22500 pg/mL
Interval 17000.0 to 26000.0
|
22000 pg/mL
Interval 19000.0 to 31000.0
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
IL-8
|
5.9 pg/mL
Interval 4.5 to 6.4
|
5.1 pg/mL
Interval 4.2 to 6.0
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
IP-10
|
319 pg/mL
Interval 268.0 to 477.0
|
228 pg/mL
Interval 184.0 to 258.0
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
MCP-2
|
29.5 pg/mL
Interval 19.0 to 34.0
|
20 pg/mL
Interval 17.0 to 22.0
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
MCP-4
|
1400 pg/mL
Interval 1310.0 to 1650.0
|
1400 pg/mL
Interval 1220.0 to 1560.0
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
MIG
|
571 pg/mL
Interval 443.0 to 684.0
|
473 pg/mL
Interval 367.0 to 722.0
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
MIP-3 alpha
|
35.5 pg/mL
Interval 24.0 to 45.0
|
20 pg/mL
Interval 17.0 to 30.0
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
MPIF-1
|
1850 pg/mL
Interval 1500.0 to 2100.0
|
1400 pg/mL
Interval 1100.0 to 1600.0
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: Post-dose1 at Day 1Population: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=26 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=25 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
E-selectin
|
5950 pg/mL
Interval 4200.0 to 9500.0
|
6000 pg/mL
Interval 4900.0 to 8900.0
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
IL-10
|
5.2 pg/mL
Interval 3.6 to 6.8
|
3.3 pg/mL
Interval 3.3 to 3.6
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
IL-18
|
198.5 pg/mL
Interval 167.0 to 267.0
|
181 pg/mL
Interval 123.0 to 200.0
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
IL-6
|
3 pg/mL
Interval 1.6 to 4.1
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
IL-6r
|
26500 pg/mL
Interval 22000.0 to 35000.0
|
24500 pg/mL
Interval 21500.0 to 31000.0
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
IL-8
|
5.1 pg/mL
Interval 4.1 to 6.3
|
4.4 pg/mL
Interval 3.8 to 5.6
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
IP-10
|
295 pg/mL
Interval 251.0 to 414.0
|
219 pg/mL
Interval 179.0 to 326.0
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
MCP-1
|
85.5 pg/mL
Interval 67.0 to 101.0
|
92 pg/mL
Interval 73.0 to 112.0
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
MCP-2
|
21 pg/mL
Interval 16.0 to 26.0
|
20 pg/mL
Interval 17.0 to 25.0
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
MCP-4
|
1360 pg/mL
Interval 1120.0 to 1600.0
|
1270 pg/mL
Interval 1100.0 to 1630.0
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
MIG
|
526 pg/mL
Interval 441.0 to 678.0
|
425 pg/mL
Interval 299.0 to 606.0
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 22.0
|
18 pg/mL
Interval 18.0 to 20.0
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
MIP-1 beta
|
282.5 pg/mL
Interval 234.0 to 408.0
|
145 pg/mL
Interval 130.0 to 207.0
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
MIP-3 alpha
|
17 pg/mL
Interval 14.0 to 28.0
|
16 pg/mL
Interval 12.0 to 23.0
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
MPIF-1
|
2300 pg/mL
Interval 2000.0 to 2600.0
|
1400 pg/mL
Interval 1200.0 to 1800.0
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
PRIMARY outcome
Timeframe: Post-dose1 at Day 2Population: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=25 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Cytokines/Chemokines Concentrations - Study Step 1
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Cytokines/Chemokines Concentrations - Study Step 1
IL-8
|
4.8 pg/mL
Interval 3.8 to 6.4
|
5 pg/mL
Interval 4.2 to 5.6
|
|
Cytokines/Chemokines Concentrations - Study Step 1
MCP-2
|
22 pg/mL
Interval 17.0 to 25.0
|
20 pg/mL
Interval 15.0 to 25.0
|
|
Cytokines/Chemokines Concentrations - Study Step 1
MPIF-1
|
1600 pg/mL
Interval 1300.0 to 2000.0
|
1300 pg/mL
Interval 890.0 to 1500.0
|
|
Cytokines/Chemokines Concentrations - Study Step 1
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
|
Cytokines/Chemokines Concentrations - Study Step 1
E-selectin
|
5800 pg/mL
Interval 4300.0 to 9300.0
|
6300 pg/mL
Interval 5000.0 to 7400.0
|
|
Cytokines/Chemokines Concentrations - Study Step 1
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Cytokines/Chemokines Concentrations - Study Step 1
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines/Chemokines Concentrations - Study Step 1
IL-10
|
3.6 pg/mL
Interval 3.3 to 4.3
|
3.3 pg/mL
Interval 3.3 to 3.7
|
|
Cytokines/Chemokines Concentrations - Study Step 1
IL-18
|
219 pg/mL
Interval 165.0 to 252.0
|
167 pg/mL
Interval 130.0 to 219.0
|
|
Cytokines/Chemokines Concentrations - Study Step 1
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Cytokines/Chemokines Concentrations - Study Step 1
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines/Chemokines Concentrations - Study Step 1
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Cytokines/Chemokines Concentrations - Study Step 1
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines/Chemokines Concentrations - Study Step 1
IL-6r
|
25000 pg/mL
Interval 18000.0 to 33000.0
|
24000 pg/mL
Interval 20000.0 to 30000.0
|
|
Cytokines/Chemokines Concentrations - Study Step 1
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Cytokines/Chemokines Concentrations - Study Step 1
IP-10
|
455 pg/mL
Interval 291.0 to 569.0
|
214 pg/mL
Interval 174.0 to 303.0
|
|
Cytokines/Chemokines Concentrations - Study Step 1
MCP-1
|
83 pg/mL
Interval 55.0 to 95.0
|
79 pg/mL
Interval 58.0 to 101.0
|
|
Cytokines/Chemokines Concentrations - Study Step 1
MCP-4
|
1300 pg/mL
Interval 1010.0 to 1600.0
|
1230 pg/mL
Interval 1010.0 to 1390.0
|
|
Cytokines/Chemokines Concentrations - Study Step 1
MIG
|
546 pg/mL
Interval 435.0 to 593.0
|
364 pg/mL
Interval 255.0 to 620.0
|
|
Cytokines/Chemokines Concentrations - Study Step 1
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 22.0
|
18 pg/mL
Interval 18.0 to 21.0
|
|
Cytokines/Chemokines Concentrations - Study Step 1
MIP-1 beta
|
200 pg/mL
Interval 160.0 to 265.0
|
149 pg/mL
Interval 126.0 to 189.0
|
|
Cytokines/Chemokines Concentrations - Study Step 1
MIP-3 alpha
|
19 pg/mL
Interval 14.0 to 25.0
|
21 pg/mL
Interval 16.0 to 28.0
|
|
Cytokines/Chemokines Concentrations - Study Step 1
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
PRIMARY outcome
Timeframe: Post-dose1 at Day 7Population: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=26 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
MCP-1
|
94 pg/mL
Interval 73.0 to 119.0
|
88.5 pg/mL
Interval 71.0 to 125.0
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
MCP-2
|
20 pg/mL
Interval 16.0 to 24.0
|
22.5 pg/mL
Interval 18.0 to 30.0
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
MCP-4
|
1250 pg/mL
Interval 1040.0 to 1390.0
|
1240 pg/mL
Interval 1010.0 to 1420.0
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
E-selectin
|
6600 pg/mL
Interval 4100.0 to 8600.0
|
6700 pg/mL
Interval 4800.0 to 8500.0
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
IL-10
|
3.6 pg/mL
Interval 3.3 to 4.9
|
3.3 pg/mL
Interval 3.3 to 3.9
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
IL-18
|
202 pg/mL
Interval 168.0 to 265.0
|
191 pg/mL
Interval 126.0 to 231.0
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
IL-6r
|
27000 pg/mL
Interval 21000.0 to 35000.0
|
25000 pg/mL
Interval 21000.0 to 31000.0
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
IL-8
|
5 pg/mL
Interval 4.2 to 6.9
|
5.1 pg/mL
Interval 4.2 to 6.7
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
IP-10
|
235 pg/mL
Interval 178.0 to 350.0
|
220.5 pg/mL
Interval 185.0 to 279.0
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
MIG
|
475 pg/mL
Interval 384.0 to 582.0
|
436.5 pg/mL
Interval 304.0 to 687.0
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 26.0
|
18 pg/mL
Interval 18.0 to 22.0
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
MIP-1 beta
|
171 pg/mL
Interval 142.0 to 243.0
|
173.5 pg/mL
Interval 146.0 to 213.0
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
MIP-3 alpha
|
18 pg/mL
Interval 14.0 to 26.0
|
22 pg/mL
Interval 16.0 to 34.0
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
MPIF-1
|
1600 pg/mL
Interval 1300.0 to 2100.0
|
1300 pg/mL
Interval 1100.0 to 1500.0
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
TNF-alpha
|
13 pg/mL
Interval 13.0 to 17.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: Post-dose1 at Day 30Population: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=25 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.4
|
3.3 pg/mL
Interval 3.3 to 3.4
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
IL-18
|
202 pg/mL
Interval 151.0 to 248.0
|
183 pg/mL
Interval 136.0 to 234.0
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
IL-6r
|
27000 pg/mL
Interval 20000.0 to 32000.0
|
26000 pg/mL
Interval 21000.0 to 30000.0
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
MCP-1
|
99 pg/mL
Interval 72.0 to 136.0
|
86 pg/mL
Interval 72.0 to 111.0
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
MIG
|
475 pg/mL
Interval 393.0 to 768.0
|
452 pg/mL
Interval 281.0 to 691.0
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
MIP-1 beta
|
175 pg/mL
Interval 141.0 to 240.0
|
147 pg/mL
Interval 126.0 to 181.0
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
MIP-3 alpha
|
20 pg/mL
Interval 15.0 to 30.0
|
20 pg/mL
Interval 16.0 to 27.0
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
MPIF-1
|
1500 pg/mL
Interval 1300.0 to 1800.0
|
1300 pg/mL
Interval 940.0 to 1500.0
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
E-selectin
|
6200 pg/mL
Interval 4300.0 to 9000.0
|
6500 pg/mL
Interval 5200.0 to 8000.0
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
IL-6
|
1.6 pg/mL
Interval 1.6 to 2.3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
IL-8
|
4.8 pg/mL
Interval 3.9 to 6.0
|
4.3 pg/mL
Interval 3.4 to 5.8
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
IP-10
|
245 pg/mL
Interval 211.0 to 349.0
|
235 pg/mL
Interval 183.0 to 264.0
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
MCP-2
|
16 pg/mL
Interval 14.0 to 23.0
|
20 pg/mL
Interval 14.0 to 24.0
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
MCP-4
|
1180 pg/mL
Interval 937.0 to 1340.0
|
1010 pg/mL
Interval 937.0 to 1210.0
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 21.0
|
18 pg/mL
Interval 18.0 to 18.0
|
PRIMARY outcome
Timeframe: Post-dose 2 at Day 30 plus 1.5 HoursPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=25 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
IL-10
|
3.3 pg/mL
Interval 3.3 to 4.5
|
3.3 pg/mL
Interval 3.3 to 4.3
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
IL-18
|
171 pg/mL
Interval 143.0 to 223.0
|
176 pg/mL
Interval 127.0 to 207.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
IL-8
|
3.2 pg/mL
Interval 3.0 to 5.6
|
4.3 pg/mL
Interval 2.7 to 5.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
IP-10
|
223 pg/mL
Interval 189.0 to 336.0
|
215 pg/mL
Interval 173.0 to 247.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
MCP-1
|
85 pg/mL
Interval 58.0 to 112.0
|
87 pg/mL
Interval 66.0 to 104.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
MCP-4
|
1250 pg/mL
Interval 1030.0 to 1400.0
|
1090 pg/mL
Interval 1020.0 to 1330.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
MIG
|
421 pg/mL
Interval 361.0 to 856.0
|
367 pg/mL
Interval 269.0 to 575.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
MIP-1 beta
|
164 pg/mL
Interval 132.0 to 196.0
|
136 pg/mL
Interval 115.0 to 170.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
MIP-3 alpha
|
17 pg/mL
Interval 10.0 to 22.0
|
14 pg/mL
Interval 11.0 to 19.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
MPIF-1
|
1400 pg/mL
Interval 1200.0 to 1500.0
|
1200 pg/mL
Interval 930.0 to 1500.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
E-selectin
|
6300 pg/mL
Interval 3900.0 to 7600.0
|
5700 pg/mL
Interval 4900.0 to 6800.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
IL-6r
|
24000 pg/mL
Interval 18000.0 to 30000.0
|
25000 pg/mL
Interval 20000.0 to 31000.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
MCP-2
|
15 pg/mL
Interval 12.0 to 23.0
|
18 pg/mL
Interval 15.0 to 22.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 22.0
|
18 pg/mL
Interval 18.0 to 20.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: Post-dose 2 at Day 30 plus 3 HoursPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=26 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=24 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
E-selectin
|
6550 pg/mL
Interval 4000.0 to 8200.0
|
5700 pg/mL
Interval 4450.0 to 6850.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
IL-10
|
3.3 pg/mL
Interval 3.3 to 4.5
|
3.3 pg/mL
Interval 3.3 to 3.4
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
IL-6r
|
26000 pg/mL
Interval 18000.0 to 31000.0
|
23000 pg/mL
Interval 19000.0 to 28500.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
IL-8
|
4.7 pg/mL
Interval 3.9 to 6.0
|
4.5 pg/mL
Interval 3.8 to 5.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
IP-10
|
208 pg/mL
Interval 182.0 to 275.0
|
205.5 pg/mL
Interval 176.0 to 243.5
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
MCP-1
|
75 pg/mL
Interval 62.0 to 95.0
|
75 pg/mL
Interval 51.0 to 85.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
MCP-2
|
15.5 pg/mL
Interval 12.0 to 27.0
|
18 pg/mL
Interval 14.5 to 22.5
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
MCP-4
|
1095 pg/mL
Interval 979.0 to 1410.0
|
1085 pg/mL
Interval 824.5 to 1250.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
MIG
|
378.5 pg/mL
Interval 313.0 to 513.0
|
358 pg/mL
Interval 237.0 to 650.5
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
MIP-1 beta
|
153 pg/mL
Interval 135.0 to 220.0
|
138 pg/mL
Interval 123.5 to 157.5
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
MPIF-1
|
1500 pg/mL
Interval 1200.0 to 1600.0
|
1200 pg/mL
Interval 980.0 to 1450.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
IL-18
|
171.5 pg/mL
Interval 146.0 to 204.0
|
158 pg/mL
Interval 104.0 to 206.5
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
IL-6
|
1.6 pg/mL
Interval 1.6 to 2.5
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 20.0
|
18 pg/mL
Interval 18.0 to 18.5
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
MIP-3 alpha
|
15 pg/mL
Interval 10.0 to 22.0
|
14 pg/mL
Interval 10.0 to 15.5
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: Post-dose 2 at Day 30 plus 6 hoursPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=26 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.7
|
3.3 pg/mL
Interval 3.3 to 3.3
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
IL-18
|
173.5 pg/mL
Interval 151.0 to 227.0
|
183 pg/mL
Interval 127.5 to 211.5
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
IL-6
|
4.4 pg/mL
Interval 2.8 to 6.7
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
IL-6r
|
23000 pg/mL
Interval 18000.0 to 29000.0
|
24500 pg/mL
Interval 20500.0 to 30500.0
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
IL-8
|
5.2 pg/mL
Interval 3.5 to 6.7
|
4.5 pg/mL
Interval 3.5 to 5.2
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
IP-10
|
210.5 pg/mL
Interval 182.0 to 248.0
|
196.5 pg/mL
Interval 160.0 to 248.5
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
MCP-1
|
116.5 pg/mL
Interval 98.0 to 132.0
|
95 pg/mL
Interval 79.0 to 121.0
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
MCP-2
|
17 pg/mL
Interval 12.0 to 24.0
|
18.5 pg/mL
Interval 15.0 to 24.0
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
MIG
|
375 pg/mL
Interval 320.0 to 505.0
|
387.5 pg/mL
Interval 239.0 to 671.0
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
MIP-3 alpha
|
16 pg/mL
Interval 10.0 to 24.0
|
16 pg/mL
Interval 12.0 to 22.0
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
MPIF-1
|
1400 pg/mL
Interval 1200.0 to 1600.0
|
1300 pg/mL
Interval 1015.0 to 1700.0
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
MCP-4
|
1245 pg/mL
Interval 954.0 to 1590.0
|
1065 pg/mL
Interval 936.0 to 1350.0
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 19.0
|
18 pg/mL
Interval 18.0 to 18.0
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
MIP-1 beta
|
177.5 pg/mL
Interval 128.0 to 225.0
|
139.5 pg/mL
Interval 127.5 to 163.5
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
E-selectin
|
6000 pg/mL
Interval 4200.0 to 8100.0
|
5850 pg/mL
Interval 4550.0 to 7000.0
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
PRIMARY outcome
Timeframe: Post-dose 2 at Day 30 plus 9 HoursPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=24 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
IL-6
|
4.8 pg/mL
Interval 3.2 to 6.7
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
E-selectin
|
6200 pg/mL
Interval 4100.0 to 7400.0
|
5500 pg/mL
Interval 4350.0 to 6850.0
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
IL-10
|
3.3 pg/mL
Interval 3.3 to 5.2
|
3.3 pg/mL
Interval 3.3 to 3.4
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
IL-18
|
177 pg/mL
Interval 139.0 to 240.0
|
165 pg/mL
Interval 115.0 to 229.5
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
5.9 pg/mL
Interval 5.9 to 6.6
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
IL-6r
|
23000 pg/mL
Interval 17000.0 to 30000.0
|
24500 pg/mL
Interval 18500.0 to 30500.0
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
IL-8
|
4.1 pg/mL
Interval 3.2 to 5.5
|
4 pg/mL
Interval 3.2 to 5.4
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
IP-10
|
217 pg/mL
Interval 180.0 to 326.0
|
204 pg/mL
Interval 168.0 to 234.0
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
MCP-1
|
103 pg/mL
Interval 88.0 to 119.0
|
80 pg/mL
Interval 55.0 to 106.0
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
MCP-2
|
18 pg/mL
Interval 14.0 to 24.0
|
18.5 pg/mL
Interval 14.5 to 20.5
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
MCP-4
|
1190 pg/mL
Interval 999.0 to 1470.0
|
1075 pg/mL
Interval 820.0 to 1295.0
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
MIG
|
424 pg/mL
Interval 384.0 to 621.0
|
350 pg/mL
Interval 300.0 to 620.0
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 19.0
|
18 pg/mL
Interval 18.0 to 18.0
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
MIP-1 beta
|
167 pg/mL
Interval 120.0 to 220.0
|
123.5 pg/mL
Interval 108.5 to 146.5
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
MIP-3 alpha
|
16 pg/mL
Interval 14.0 to 23.0
|
15.5 pg/mL
Interval 11.0 to 19.0
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
MPIF-1
|
1400 pg/mL
Interval 1100.0 to 1600.0
|
1200 pg/mL
Interval 950.0 to 1400.0
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: Post-dose 2 at Day 30 plus 12 HoursPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=25 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=25 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
IL-6
|
6.4 pg/mL
Interval 5.0 to 9.0
|
1.6 pg/mL
Interval 1.6 to 1.7
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
MCP-1
|
117 pg/mL
Interval 96.0 to 150.0
|
95 pg/mL
Interval 71.0 to 121.0
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
MIP-3 alpha
|
20 pg/mL
Interval 15.0 to 26.0
|
14 pg/mL
Interval 11.0 to 20.0
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
E-selectin
|
5800 pg/mL
Interval 4000.0 to 7800.0
|
5800 pg/mL
Interval 4500.0 to 7000.0
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
IFN-γ
|
2.3 pg/mL
Interval 1.6 to 3.1
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.8
|
3.3 pg/mL
Interval 3.3 to 3.3
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
IL-18
|
166 pg/mL
Interval 146.0 to 212.0
|
174 pg/mL
Interval 124.0 to 220.0
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
IL-6r
|
23000 pg/mL
Interval 21000.0 to 31000.0
|
24000 pg/mL
Interval 21000.0 to 32000.0
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
IL-8
|
4.9 pg/mL
Interval 4.1 to 6.0
|
5.2 pg/mL
Interval 3.2 to 6.0
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
IP-10
|
240 pg/mL
Interval 228.0 to 335.0
|
200 pg/mL
Interval 166.0 to 240.0
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
MCP-2
|
20 pg/mL
Interval 14.0 to 26.0
|
18 pg/mL
Interval 15.0 to 22.0
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
MCP-4
|
1100 pg/mL
Interval 916.0 to 1330.0
|
1040 pg/mL
Interval 852.0 to 1170.0
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
MIG
|
499 pg/mL
Interval 398.0 to 872.0
|
377 pg/mL
Interval 290.0 to 689.0
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 20.0
|
18 pg/mL
Interval 18.0 to 18.0
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
MIP-1 beta
|
191 pg/mL
Interval 162.0 to 238.0
|
134 pg/mL
Interval 118.0 to 162.0
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
MPIF-1
|
1500 pg/mL
Interval 1100.0 to 1700.0
|
1300 pg/mL
Interval 1100.0 to 1500.0
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: Post-dose 2 at Day 30 plus 18 HoursPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=14 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
MCP-1
|
104.5 pg/mL
Interval 76.0 to 116.0
|
96 pg/mL
Interval 91.0 to 106.0
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
MCP-2
|
33 pg/mL
Interval 19.0 to 54.0
|
22 pg/mL
Interval 16.0 to 23.0
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
MCP-4
|
1220 pg/mL
Interval 1090.0 to 1290.0
|
1260 pg/mL
Interval 1000.0 to 1340.0
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
MIG
|
565.5 pg/mL
Interval 373.0 to 791.0
|
442 pg/mL
Interval 300.0 to 633.0
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
MIP-1 beta
|
283.5 pg/mL
Interval 228.0 to 327.0
|
144 pg/mL
Interval 111.0 to 176.0
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
E-selectin
|
5400 pg/mL
Interval 3400.0 to 8000.0
|
4500 pg/mL
Interval 2900.0 to 5800.0
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
IFN-γ
|
5.2 pg/mL
Interval 1.6 to 7.4
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
IL-10
|
4.5 pg/mL
Interval 3.3 to 6.0
|
3.3 pg/mL
Interval 3.3 to 3.4
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
IL-18
|
164.5 pg/mL
Interval 151.0 to 241.0
|
168 pg/mL
Interval 128.0 to 197.0
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
IL-6
|
6.3 pg/mL
Interval 4.2 to 8.3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
IL-6r
|
19500 pg/mL
Interval 13000.0 to 24000.0
|
24000 pg/mL
Interval 17000.0 to 32000.0
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
IL-8
|
4.8 pg/mL
Interval 4.1 to 5.4
|
5 pg/mL
Interval 3.5 to 5.9
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
IP-10
|
589.5 pg/mL
Interval 296.0 to 715.0
|
216 pg/mL
Interval 196.0 to 430.0
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 23.0
|
18 pg/mL
Interval 18.0 to 23.0
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
MIP-3 alpha
|
24 pg/mL
Interval 19.0 to 31.0
|
17 pg/mL
Interval 11.0 to 20.0
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
MPIF-1
|
1600 pg/mL
Interval 1300.0 to 2300.0
|
1400 pg/mL
Interval 1100.0 to 1700.0
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: Post-dose 2 at Day 31Population: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=25 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
IFN-γ
|
4.8 pg/mL
Interval 1.7 to 8.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
IL-10
|
4.8 pg/mL
Interval 3.3 to 6.3
|
3.3 pg/mL
Interval 3.3 to 3.3
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
IL-18
|
185 pg/mL
Interval 151.0 to 258.0
|
166 pg/mL
Interval 137.0 to 217.0
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
IL-2
|
8.5 pg/mL
Interval 5.9 to 8.5
|
5.9 pg/mL
Interval 5.9 to 8.5
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
IL-6
|
3.6 pg/mL
Interval 1.7 to 7.2
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
E-selectin
|
6800 pg/mL
Interval 4300.0 to 8200.0
|
5800 pg/mL
Interval 5200.0 to 7100.0
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
IL-6r
|
26000 pg/mL
Interval 17000.0 to 33000.0
|
24000 pg/mL
Interval 22000.0 to 31000.0
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
IL-8
|
5.6 pg/mL
Interval 4.8 to 7.0
|
4.8 pg/mL
Interval 3.9 to 5.9
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
IP-10
|
763 pg/mL
Interval 405.0 to 1130.0
|
212 pg/mL
Interval 197.0 to 270.0
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
MCP-1
|
101 pg/mL
Interval 79.0 to 137.0
|
71 pg/mL
Interval 60.0 to 93.0
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
MCP-2
|
35 pg/mL
Interval 19.0 to 67.0
|
17 pg/mL
Interval 14.0 to 19.0
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
MCP-4
|
1250 pg/mL
Interval 1090.0 to 1400.0
|
1090 pg/mL
Interval 912.0 to 1330.0
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
MIG
|
763 pg/mL
Interval 604.0 to 1260.0
|
427 pg/mL
Interval 308.0 to 597.0
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 21.0
|
18 pg/mL
Interval 18.0 to 18.0
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
MIP-1 beta
|
383 pg/mL
Interval 301.0 to 540.0
|
142 pg/mL
Interval 120.0 to 176.0
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
MIP-3 alpha
|
22 pg/mL
Interval 17.0 to 25.0
|
19 pg/mL
Interval 12.0 to 28.0
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
MPIF-1
|
2000 pg/mL
Interval 1500.0 to 2300.0
|
1100 pg/mL
Interval 950.0 to 1600.0
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
TNF-alpha
|
15 pg/mL
Interval 13.0 to 21.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: Post-dose 2 at Day 32Population: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=25 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
IL-6r
|
27000 pg/mL
Interval 21000.0 to 32000.0
|
24000 pg/mL
Interval 21000.0 to 31000.0
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
IP-10
|
760 pg/mL
Interval 492.0 to 993.0
|
226 pg/mL
Interval 192.0 to 276.0
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
MCP-1
|
75 pg/mL
Interval 55.0 to 94.0
|
77 pg/mL
Interval 65.0 to 121.0
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
MIG
|
850 pg/mL
Interval 667.0 to 1070.0
|
410 pg/mL
Interval 320.0 to 581.0
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
MPIF-1
|
1800 pg/mL
Interval 1400.0 to 2300.0
|
1200 pg/mL
Interval 990.0 to 1700.0
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
E-selectin
|
7000 pg/mL
Interval 4400.0 to 9100.0
|
6000 pg/mL
Interval 4900.0 to 8000.0
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
IL-10
|
3.5 pg/mL
Interval 3.3 to 5.3
|
3.3 pg/mL
Interval 3.3 to 3.5
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
IL-18
|
238 pg/mL
Interval 195.0 to 269.0
|
190 pg/mL
Interval 135.0 to 238.0
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
IL-2
|
5.9 pg/mL
Interval 5.9 to 7.0
|
5.9 pg/mL
Interval 5.9 to 7.0
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
IL-6
|
1.6 pg/mL
Interval 1.6 to 2.5
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
IL-8
|
5.5 pg/mL
Interval 4.3 to 6.5
|
5.1 pg/mL
Interval 4.0 to 6.5
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
MCP-2
|
24 pg/mL
Interval 17.0 to 31.0
|
21 pg/mL
Interval 17.0 to 25.0
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
MCP-4
|
1350 pg/mL
Interval 1080.0 to 1580.0
|
1260 pg/mL
Interval 1010.0 to 1560.0
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 19.0
|
18 pg/mL
Interval 18.0 to 23.0
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
MIP-1 beta
|
268 pg/mL
Interval 222.0 to 307.0
|
142 pg/mL
Interval 124.0 to 171.0
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
MIP-3 alpha
|
23 pg/mL
Interval 16.0 to 30.0
|
19 pg/mL
Interval 13.0 to 28.0
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
TNF-alpha
|
13 pg/mL
Interval 13.0 to 14.0
|
13 pg/mL
Interval 13.0 to 13.0
|
PRIMARY outcome
Timeframe: Post-dose 2 at Day 33Population: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=25 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
IL-6r
|
26000 pg/mL
Interval 21000.0 to 33000.0
|
25000 pg/mL
Interval 21000.0 to 28000.0
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
IL-8
|
5.5 pg/mL
Interval 4.3 to 7.4
|
5.5 pg/mL
Interval 4.3 to 6.2
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
IP-10
|
366 pg/mL
Interval 288.0 to 524.0
|
249 pg/mL
Interval 220.0 to 319.0
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
E-selectin
|
6400 pg/mL
Interval 4400.0 to 8700.0
|
6300 pg/mL
Interval 5100.0 to 8000.0
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
MCP-1
|
85 pg/mL
Interval 65.0 to 101.0
|
93 pg/mL
Interval 77.0 to 131.0
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.6
|
3.3 pg/mL
Interval 3.3 to 3.6
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
IL-18
|
256 pg/mL
Interval 195.0 to 351.0
|
181 pg/mL
Interval 142.0 to 231.0
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
MCP-2
|
20 pg/mL
Interval 16.0 to 28.0
|
20 pg/mL
Interval 17.0 to 26.0
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
MCP-4
|
1390 pg/mL
Interval 1190.0 to 1600.0
|
1280 pg/mL
Interval 1090.0 to 1600.0
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
MIG
|
796 pg/mL
Interval 586.0 to 908.0
|
537 pg/mL
Interval 456.0 to 722.0
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
MIP-1 alpha
|
22 pg/mL
Interval 18.0 to 24.0
|
19 pg/mL
Interval 18.0 to 22.0
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
MIP-1 beta
|
241 pg/mL
Interval 175.0 to 279.0
|
163 pg/mL
Interval 135.0 to 201.0
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
MIP-3 alpha
|
25 pg/mL
Interval 21.0 to 40.0
|
25 pg/mL
Interval 21.0 to 32.0
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
MPIF-1
|
1800 pg/mL
Interval 1400.0 to 2200.0
|
1300 pg/mL
Interval 1100.0 to 1600.0
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.4
|
PRIMARY outcome
Timeframe: Post-dose 2 at Day 37Population: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=25 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
E-selectin
|
6200 pg/mL
Interval 4000.0 to 8200.0
|
6000 pg/mL
Interval 5000.0 to 7700.0
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.3
|
3.3 pg/mL
Interval 3.3 to 3.3
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
IL-18
|
194 pg/mL
Interval 156.0 to 256.0
|
166 pg/mL
Interval 123.0 to 196.0
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
IL-6r
|
28000 pg/mL
Interval 16000.0 to 35000.0
|
25000 pg/mL
Interval 20000.0 to 27000.0
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
IL-8
|
5.3 pg/mL
Interval 3.9 to 6.6
|
5.5 pg/mL
Interval 4.6 to 6.0
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
IP-10
|
259 pg/mL
Interval 213.0 to 296.0
|
223 pg/mL
Interval 179.0 to 289.0
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
MCP-1
|
83 pg/mL
Interval 66.0 to 109.0
|
85 pg/mL
Interval 63.0 to 99.0
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
MCP-2
|
17 pg/mL
Interval 13.0 to 23.0
|
20 pg/mL
Interval 16.0 to 24.0
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
MCP-4
|
1220 pg/mL
Interval 1110.0 to 1480.0
|
1210 pg/mL
Interval 1010.0 to 1340.0
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
MIG
|
447 pg/mL
Interval 398.0 to 535.0
|
364 pg/mL
Interval 284.0 to 472.0
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 23.0
|
18 pg/mL
Interval 18.0 to 19.0
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
MIP-1 beta
|
150 pg/mL
Interval 119.0 to 190.0
|
151 pg/mL
Interval 126.0 to 175.0
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
MIP-3 alpha
|
18 pg/mL
Interval 15.0 to 28.0
|
18 pg/mL
Interval 15.0 to 24.0
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
MPIF-1
|
1600 pg/mL
Interval 1200.0 to 1800.0
|
1300 pg/mL
Interval 1000.0 to 1400.0
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
PRIMARY outcome
Timeframe: Pre-dose 1 at Day 0Population: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point.
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=6 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=9 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Concentrations of Cytokines and Chemokines - Step 2
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Concentrations of Cytokines and Chemokines - Step 2
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines and Chemokines - Step 2
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Concentrations of Cytokines and Chemokines - Step 2
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines and Chemokines - Step 2
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.8
|
3.3 pg/mL
Interval 3.3 to 3.3
|
|
Concentrations of Cytokines and Chemokines - Step 2
IL-18
|
199.5 pg/mL
Interval 175.0 to 377.0
|
179 pg/mL
Interval 152.0 to 182.0
|
|
Concentrations of Cytokines and Chemokines - Step 2
E-selectin
|
8100 pg/mL
Interval 4200.0 to 8900.0
|
5400 pg/mL
Interval 4400.0 to 5500.0
|
|
Concentrations of Cytokines and Chemokines - Step 2
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Concentrations of Cytokines and Chemokines - Step 2
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Concentrations of Cytokines and Chemokines - Step 2
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines and Chemokines - Step 2
IL-6r
|
32000 pg/mL
Interval 29000.0 to 36000.0
|
30000 pg/mL
Interval 28000.0 to 36000.0
|
|
Concentrations of Cytokines and Chemokines - Step 2
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Concentrations of Cytokines and Chemokines - Step 2
IL-8
|
5.3 pg/mL
Interval 3.5 to 11.0
|
4.4 pg/mL
Interval 3.5 to 6.2
|
|
Concentrations of Cytokines and Chemokines - Step 2
IP-10
|
300.5 pg/mL
Interval 275.0 to 370.0
|
234 pg/mL
Interval 166.0 to 278.0
|
|
Concentrations of Cytokines and Chemokines - Step 2
MCP-1
|
86.5 pg/mL
Interval 77.0 to 132.0
|
87 pg/mL
Interval 67.0 to 96.0
|
|
Concentrations of Cytokines and Chemokines - Step 2
MCP-2
|
22.5 pg/mL
Interval 17.0 to 27.0
|
27 pg/mL
Interval 19.0 to 30.0
|
|
Concentrations of Cytokines and Chemokines - Step 2
MCP-4
|
1805 pg/mL
Interval 1300.0 to 2010.0
|
2120 pg/mL
Interval 1720.0 to 2260.0
|
|
Concentrations of Cytokines and Chemokines - Step 2
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 18.0
|
18 pg/mL
Interval 18.0 to 18.0
|
|
Concentrations of Cytokines and Chemokines - Step 2
MIP-1 beta
|
234 pg/mL
Interval 186.0 to 255.0
|
253 pg/mL
Interval 200.0 to 300.0
|
|
Concentrations of Cytokines and Chemokines - Step 2
MIP-3 alpha
|
28.5 pg/mL
Interval 23.0 to 64.0
|
29 pg/mL
Interval 17.0 to 42.0
|
|
Concentrations of Cytokines and Chemokines - Step 2
MPIF-1
|
1095 pg/mL
Interval 820.0 to 1200.0
|
1100 pg/mL
Interval 930.0 to 1200.0
|
|
Concentrations of Cytokines and Chemokines - Step 2
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Concentrations of Cytokines and Chemokines - Step 2
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: Post-dose 1 at Day 1Population: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point.
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the HBsAg/AS\_2 Group.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=7 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Cytokines and Chemokines Concentrations - Step 2
E-selectin
|
7900 pg/mL
Interval 4300.0 to 9100.0
|
—
|
|
Cytokines and Chemokines Concentrations - Step 2
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
—
|
|
Cytokines and Chemokines Concentrations - Step 2
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
—
|
|
Cytokines and Chemokines Concentrations - Step 2
IL-10
|
3.8 pg/mL
Interval 3.3 to 4.7
|
—
|
|
Cytokines and Chemokines Concentrations - Step 2
IL-18
|
206 pg/mL
Interval 182.0 to 260.0
|
—
|
|
Cytokines and Chemokines Concentrations - Step 2
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
—
|
|
Cytokines and Chemokines Concentrations - Step 2
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
—
|
|
Cytokines and Chemokines Concentrations - Step 2
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
—
|
|
Cytokines and Chemokines Concentrations - Step 2
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
—
|
|
Cytokines and Chemokines Concentrations - Step 2
IL-6
|
1.7 pg/mL
Interval 1.6 to 2.6
|
—
|
|
Cytokines and Chemokines Concentrations - Step 2
IL-6r
|
24000 pg/mL
Interval 22000.0 to 33000.0
|
—
|
|
Cytokines and Chemokines Concentrations - Step 2
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
—
|
|
Cytokines and Chemokines Concentrations - Step 2
IL-8
|
3.9 pg/mL
Interval 2.6 to 7.1
|
—
|
|
Cytokines and Chemokines Concentrations - Step 2
IP-10
|
294 pg/mL
Interval 199.0 to 390.0
|
—
|
|
Cytokines and Chemokines Concentrations - Step 2
MCP-1
|
35 pg/mL
Interval 27.0 to 114.0
|
—
|
|
Cytokines and Chemokines Concentrations - Step 2
MCP-2
|
26 pg/mL
Interval 20.0 to 29.0
|
—
|
|
Cytokines and Chemokines Concentrations - Step 2
MCP-4
|
1240 pg/mL
Interval 1130.0 to 1640.0
|
—
|
|
Cytokines and Chemokines Concentrations - Step 2
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 32.0
|
—
|
|
Cytokines and Chemokines Concentrations - Step 2
MIP-1 beta
|
318 pg/mL
Interval 241.0 to 391.0
|
—
|
|
Cytokines and Chemokines Concentrations - Step 2
MIP-3 alpha
|
32 pg/mL
Interval 17.0 to 46.0
|
—
|
|
Cytokines and Chemokines Concentrations - Step 2
MPIF-1
|
1400 pg/mL
Interval 1200.0 to 1500.0
|
—
|
|
Cytokines and Chemokines Concentrations - Step 2
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
—
|
|
Cytokines and Chemokines Concentrations - Step 2
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
—
|
PRIMARY outcome
Timeframe: Post-dose 1 at Day 30Population: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point.
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the HBsAg/AS\_2 Group.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=8 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Concentrations of Cytokines and Chemokines During Step 2
E-selectin
|
6200 pg/mL
Interval 3600.0 to 8450.0
|
—
|
|
Concentrations of Cytokines and Chemokines During Step 2
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
—
|
|
Concentrations of Cytokines and Chemokines During Step 2
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
—
|
|
Concentrations of Cytokines and Chemokines During Step 2
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.6
|
—
|
|
Concentrations of Cytokines and Chemokines During Step 2
IL-18
|
166.5 pg/mL
Interval 132.5 to 271.5
|
—
|
|
Concentrations of Cytokines and Chemokines During Step 2
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
—
|
|
Concentrations of Cytokines and Chemokines During Step 2
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
—
|
|
Concentrations of Cytokines and Chemokines During Step 2
IL-4
|
9.4 pg/mL
Interval 9.4 to 11.2
|
—
|
|
Concentrations of Cytokines and Chemokines During Step 2
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
—
|
|
Concentrations of Cytokines and Chemokines During Step 2
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.7
|
—
|
|
Concentrations of Cytokines and Chemokines During Step 2
IL-6r
|
29000 pg/mL
Interval 24500.0 to 33500.0
|
—
|
|
Concentrations of Cytokines and Chemokines During Step 2
IL-7
|
8.2 pg/mL
Interval 8.2 to 10.1
|
—
|
|
Concentrations of Cytokines and Chemokines During Step 2
IL-8
|
4.3 pg/mL
Interval 3.1 to 8.4
|
—
|
|
Concentrations of Cytokines and Chemokines During Step 2
IP-10
|
231.5 pg/mL
Interval 160.5 to 318.5
|
—
|
|
Concentrations of Cytokines and Chemokines During Step 2
MCP-1
|
46 pg/mL
Interval 35.0 to 115.5
|
—
|
|
Concentrations of Cytokines and Chemokines During Step 2
MCP-2
|
19.5 pg/mL
Interval 17.0 to 20.5
|
—
|
|
Concentrations of Cytokines and Chemokines During Step 2
MCP-4
|
1340 pg/mL
Interval 1115.0 to 1450.0
|
—
|
|
Concentrations of Cytokines and Chemokines During Step 2
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 18.0
|
—
|
|
Concentrations of Cytokines and Chemokines During Step 2
MIP-1 beta
|
172 pg/mL
Interval 158.5 to 196.5
|
—
|
|
Concentrations of Cytokines and Chemokines During Step 2
MIP-3 alpha
|
25 pg/mL
Interval 15.0 to 30.5
|
—
|
|
Concentrations of Cytokines and Chemokines During Step 2
MPIF-1
|
1200 pg/mL
Interval 855.0 to 1400.0
|
—
|
|
Concentrations of Cytokines and Chemokines During Step 2
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
—
|
|
Concentrations of Cytokines and Chemokines During Step 2
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
—
|
PRIMARY outcome
Timeframe: Post-dose2 at Day 30 plus 6 HoursPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point.
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the HBsAg/AS\_2 Group.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=7 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Concentrations of Cytokines and Chemokines in Step 2
E-selectin
|
5400 pg/mL
Interval 3400.0 to 8300.0
|
—
|
|
Concentrations of Cytokines and Chemokines in Step 2
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
—
|
|
Concentrations of Cytokines and Chemokines in Step 2
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
—
|
|
Concentrations of Cytokines and Chemokines in Step 2
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.3
|
—
|
|
Concentrations of Cytokines and Chemokines in Step 2
IL-18
|
172 pg/mL
Interval 150.0 to 247.0
|
—
|
|
Concentrations of Cytokines and Chemokines in Step 2
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
—
|
|
Concentrations of Cytokines and Chemokines in Step 2
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
—
|
|
Concentrations of Cytokines and Chemokines in Step 2
IL-4
|
9.4 pg/mL
Interval 9.4 to 10.0
|
—
|
|
Concentrations of Cytokines and Chemokines in Step 2
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
—
|
|
Concentrations of Cytokines and Chemokines in Step 2
IL-6
|
3.7 pg/mL
Interval 1.6 to 4.7
|
—
|
|
Concentrations of Cytokines and Chemokines in Step 2
IL-6r
|
34000 pg/mL
Interval 27000.0 to 43000.0
|
—
|
|
Concentrations of Cytokines and Chemokines in Step 2
IL-7
|
12 pg/mL
Interval 8.2 to 21.0
|
—
|
|
Concentrations of Cytokines and Chemokines in Step 2
IL-8
|
6.1 pg/mL
Interval 3.6 to 9.1
|
—
|
|
Concentrations of Cytokines and Chemokines in Step 2
IP-10
|
163 pg/mL
Interval 128.0 to 205.0
|
—
|
|
Concentrations of Cytokines and Chemokines in Step 2
MCP-1
|
59 pg/mL
Interval 27.0 to 86.0
|
—
|
|
Concentrations of Cytokines and Chemokines in Step 2
MCP-2
|
22 pg/mL
Interval 18.0 to 25.0
|
—
|
|
Concentrations of Cytokines and Chemokines in Step 2
MCP-4
|
1330 pg/mL
Interval 979.0 to 1540.0
|
—
|
|
Concentrations of Cytokines and Chemokines in Step 2
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 18.0
|
—
|
|
Concentrations of Cytokines and Chemokines in Step 2
MIP-1 beta
|
182 pg/mL
Interval 154.0 to 266.0
|
—
|
|
Concentrations of Cytokines and Chemokines in Step 2
MIP-3 alpha
|
21 pg/mL
Interval 13.0 to 28.0
|
—
|
|
Concentrations of Cytokines and Chemokines in Step 2
MPIF-1
|
1300 pg/mL
Interval 980.0 to 1700.0
|
—
|
|
Concentrations of Cytokines and Chemokines in Step 2
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
—
|
|
Concentrations of Cytokines and Chemokines in Step 2
TNF-beta
|
3 pg/mL
Interval 3.0 to 6.3
|
—
|
PRIMARY outcome
Timeframe: Post-dose 2 at Day 31Population: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point.
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the HBsAg/AS\_2 Group.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=8 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Concentrations of Cytokines/Chemokines - Step 2
E-selectin
|
7450 pg/mL
Interval 4600.0 to 10500.0
|
—
|
|
Concentrations of Cytokines/Chemokines - Step 2
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
—
|
|
Concentrations of Cytokines/Chemokines - Step 2
IFN-γ
|
6.2 pg/mL
Interval 3.4 to 17.6
|
—
|
|
Concentrations of Cytokines/Chemokines - Step 2
IL-10
|
3.3 pg/mL
Interval 3.3 to 4.4
|
—
|
|
Concentrations of Cytokines/Chemokines - Step 2
IL-18
|
234 pg/mL
Interval 181.0 to 339.5
|
—
|
|
Concentrations of Cytokines/Chemokines - Step 2
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
—
|
|
Concentrations of Cytokines/Chemokines - Step 2
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
—
|
|
Concentrations of Cytokines/Chemokines - Step 2
IL-4
|
9.7 pg/mL
Interval 9.4 to 10.0
|
—
|
|
Concentrations of Cytokines/Chemokines - Step 2
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
—
|
|
Concentrations of Cytokines/Chemokines - Step 2
IL-6
|
4 pg/mL
Interval 2.2 to 5.7
|
—
|
|
Concentrations of Cytokines/Chemokines - Step 2
IL-6r
|
30500 pg/mL
Interval 27000.0 to 41500.0
|
—
|
|
Concentrations of Cytokines/Chemokines - Step 2
IL-7
|
10.1 pg/mL
Interval 8.2 to 23.5
|
—
|
|
Concentrations of Cytokines/Chemokines - Step 2
IL-8
|
7.9 pg/mL
Interval 7.3 to 10.9
|
—
|
|
Concentrations of Cytokines/Chemokines - Step 2
IP-10
|
737.5 pg/mL
Interval 510.0 to 1270.0
|
—
|
|
Concentrations of Cytokines/Chemokines - Step 2
MCP-1
|
142.5 pg/mL
Interval 104.0 to 153.0
|
—
|
|
Concentrations of Cytokines/Chemokines - Step 2
MCP-2
|
40.5 pg/mL
Interval 32.0 to 72.5
|
—
|
|
Concentrations of Cytokines/Chemokines - Step 2
MCP-4
|
1330 pg/mL
Interval 974.0 to 1780.0
|
—
|
|
Concentrations of Cytokines/Chemokines - Step 2
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 18.0
|
—
|
|
Concentrations of Cytokines/Chemokines - Step 2
MIP-1 beta
|
580 pg/mL
Interval 359.5 to 780.5
|
—
|
|
Concentrations of Cytokines/Chemokines - Step 2
MIP-3 alpha
|
28 pg/mL
Interval 19.0 to 39.5
|
—
|
|
Concentrations of Cytokines/Chemokines - Step 2
MPIF-1
|
1750 pg/mL
Interval 1500.0 to 1850.0
|
—
|
|
Concentrations of Cytokines/Chemokines - Step 2
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
—
|
|
Concentrations of Cytokines/Chemokines - Step 2
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
—
|
PRIMARY outcome
Timeframe: Post-dose 2 at Day 37Population: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point.
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the HBsAg/AS\_2 Group.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=8 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Concentrations of Cytokines/Chemokines in Step 2
MCP-2
|
18.5 pg/mL
Interval 15.0 to 23.0
|
—
|
|
Concentrations of Cytokines/Chemokines in Step 2
MCP-4
|
1275 pg/mL
Interval 881.5 to 1635.0
|
—
|
|
Concentrations of Cytokines/Chemokines in Step 2
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 18.0
|
—
|
|
Concentrations of Cytokines/Chemokines in Step 2
MIP-1 beta
|
174 pg/mL
Interval 152.5 to 187.5
|
—
|
|
Concentrations of Cytokines/Chemokines in Step 2
MIP-3 alpha
|
17 pg/mL
Interval 11.5 to 94.0
|
—
|
|
Concentrations of Cytokines/Chemokines in Step 2
MPIF-1
|
1100 pg/mL
Interval 995.0 to 1450.0
|
—
|
|
Concentrations of Cytokines/Chemokines in Step 2
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
—
|
|
Concentrations of Cytokines/Chemokines in Step 2
TNF-beta
|
3 pg/mL
Interval 3.0 to 11.2
|
—
|
|
Concentrations of Cytokines/Chemokines in Step 2
E-selectin
|
6550 pg/mL
Interval 3250.0 to 8450.0
|
—
|
|
Concentrations of Cytokines/Chemokines in Step 2
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
—
|
|
Concentrations of Cytokines/Chemokines in Step 2
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
—
|
|
Concentrations of Cytokines/Chemokines in Step 2
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.8
|
—
|
|
Concentrations of Cytokines/Chemokines in Step 2
IL-18
|
232 pg/mL
Interval 145.5 to 322.0
|
—
|
|
Concentrations of Cytokines/Chemokines in Step 2
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
—
|
|
Concentrations of Cytokines/Chemokines in Step 2
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
—
|
|
Concentrations of Cytokines/Chemokines in Step 2
IL-4
|
9.7 pg/mL
Interval 9.4 to 14.0
|
—
|
|
Concentrations of Cytokines/Chemokines in Step 2
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
—
|
|
Concentrations of Cytokines/Chemokines in Step 2
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.7
|
—
|
|
Concentrations of Cytokines/Chemokines in Step 2
IL-6r
|
28000 pg/mL
Interval 26500.0 to 34500.0
|
—
|
|
Concentrations of Cytokines/Chemokines in Step 2
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
—
|
|
Concentrations of Cytokines/Chemokines in Step 2
IL-8
|
8.5 pg/mL
Interval 6.7 to 9.7
|
—
|
|
Concentrations of Cytokines/Chemokines in Step 2
IP-10
|
170 pg/mL
Interval 143.0 to 210.0
|
—
|
|
Concentrations of Cytokines/Chemokines in Step 2
MCP-1
|
72.5 pg/mL
Interval 27.0 to 104.0
|
—
|
PRIMARY outcome
Timeframe: Post-dose 2 at Day 180Population: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point.
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the Engerix-B\_2 Group.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=9 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Concentrations of Cytokines/Chemokines During Step 2
E-selectin
|
4900 pg/mL
Interval 4300.0 to 5800.0
|
—
|
|
Concentrations of Cytokines/Chemokines During Step 2
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
—
|
|
Concentrations of Cytokines/Chemokines During Step 2
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
—
|
|
Concentrations of Cytokines/Chemokines During Step 2
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.3
|
—
|
|
Concentrations of Cytokines/Chemokines During Step 2
IL-18
|
159 pg/mL
Interval 144.0 to 190.0
|
—
|
|
Concentrations of Cytokines/Chemokines During Step 2
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
—
|
|
Concentrations of Cytokines/Chemokines During Step 2
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
—
|
|
Concentrations of Cytokines/Chemokines During Step 2
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
—
|
|
Concentrations of Cytokines/Chemokines During Step 2
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
—
|
|
Concentrations of Cytokines/Chemokines During Step 2
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
—
|
|
Concentrations of Cytokines/Chemokines During Step 2
IL-6r
|
24000 pg/mL
Interval 24000.0 to 32000.0
|
—
|
|
Concentrations of Cytokines/Chemokines During Step 2
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
—
|
|
Concentrations of Cytokines/Chemokines During Step 2
IL-8
|
4.4 pg/mL
Interval 3.5 to 5.3
|
—
|
|
Concentrations of Cytokines/Chemokines During Step 2
IP-10
|
156 pg/mL
Interval 121.0 to 260.0
|
—
|
|
Concentrations of Cytokines/Chemokines During Step 2
MCP-1
|
77 pg/mL
Interval 57.0 to 77.0
|
—
|
|
Concentrations of Cytokines/Chemokines During Step 2
MCP-2
|
20 pg/mL
Interval 14.0 to 27.0
|
—
|
|
Concentrations of Cytokines/Chemokines During Step 2
MCP-4
|
1640 pg/mL
Interval 1540.0 to 1810.0
|
—
|
|
Concentrations of Cytokines/Chemokines During Step 2
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 18.0
|
—
|
|
Concentrations of Cytokines/Chemokines During Step 2
MIP-1 beta
|
189 pg/mL
Interval 177.0 to 257.0
|
—
|
|
Concentrations of Cytokines/Chemokines During Step 2
MIP-3 alpha
|
25 pg/mL
Interval 13.0 to 32.0
|
—
|
|
Concentrations of Cytokines/Chemokines During Step 2
MPIF-1
|
920 pg/mL
Interval 830.0 to 970.0
|
—
|
|
Concentrations of Cytokines/Chemokines During Step 2
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
—
|
|
Concentrations of Cytokines/Chemokines During Step 2
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
—
|
PRIMARY outcome
Timeframe: Post-dose 3 at Day 180 plus 6 HoursPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point.
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.The analysis was performed only on theEngerix-B\_2 Group.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=9 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
E-selectin
|
4600 pg/mL
Interval 4100.0 to 5800.0
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.3
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
IL-18
|
144 pg/mL
Interval 133.0 to 152.0
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
IL-6r
|
25000 pg/mL
Interval 24000.0 to 30000.0
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
IL-8
|
3.5 pg/mL
Interval 2.6 to 4.4
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
IP-10
|
145 pg/mL
Interval 105.0 to 214.0
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
MCP-1
|
46 pg/mL
Interval 35.0 to 67.0
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
MCP-2
|
22 pg/mL
Interval 15.0 to 26.0
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
MCP-4
|
1640 pg/mL
Interval 1350.0 to 1720.0
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 18.0
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
MIP-1 beta
|
193 pg/mL
Interval 175.0 to 211.0
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
MIP-3 alpha
|
21 pg/mL
Interval 15.0 to 25.0
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
MPIF-1
|
890 pg/mL
Interval 840.0 to 1100.0
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
—
|
PRIMARY outcome
Timeframe: Post-dose 3 at Day 181Population: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point.
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the Engerix-B\_2 Group.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=8 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
E-selectin
|
4900 pg/mL
Interval 4300.0 to 5900.0
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.8
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
IL-18
|
152 pg/mL
Interval 140.5 to 192.0
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
IL-4
|
9.4 pg/mL
Interval 9.4 to 11.2
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
IL-6r
|
24500 pg/mL
Interval 22500.0 to 31500.0
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
IL-8
|
3.5 pg/mL
Interval 2.6 to 3.5
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
IP-10
|
152 pg/mL
Interval 119.5 to 211.5
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
MCP-1
|
67 pg/mL
Interval 35.0 to 86.5
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
MCP-2
|
19.5 pg/mL
Interval 13.0 to 25.5
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
MCP-4
|
1720 pg/mL
Interval 1390.0 to 1790.0
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 18.0
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
MIP-1 beta
|
173.5 pg/mL
Interval 166.5 to 213.0
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
MIP-3 alpha
|
17 pg/mL
Interval 15.0 to 21.0
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
MPIF-1
|
875 pg/mL
Interval 745.0 to 1100.0
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
—
|
PRIMARY outcome
Timeframe: Post-dose 3 at Day 187Population: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the Engerix-B\_2 Group.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=5 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
E-selectin
|
4600 pg/mL
Interval 4200.0 to 5500.0
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.3
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
IL-18
|
163 pg/mL
Interval 137.0 to 167.0
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
IL-6r
|
30000 pg/mL
Interval 26000.0 to 35000.0
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
IL-8
|
3.5 pg/mL
Interval 3.5 to 4.4
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
IP-10
|
201 pg/mL
Interval 107.0 to 201.0
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
MCP-1
|
35 pg/mL
Interval 35.0 to 35.0
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
MCP-2
|
22 pg/mL
Interval 17.0 to 25.0
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
MCP-4
|
1810 pg/mL
Interval 1720.0 to 2120.0
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 18.0
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
MIP-1 beta
|
175 pg/mL
Interval 175.0 to 193.0
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
MIP-3 alpha
|
17 pg/mL
Interval 17.0 to 25.0
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
MPIF-1
|
820 pg/mL
Interval 750.0 to 970.0
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
—
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (PRE) and Day 60 (D60) post-vaccinationPopulation: The analysis was performed on the ATP cohort for adaptive immunogenicity up to Day 60 (step 1 only) which included all evaluable subjects who complied with the protocol and for whom data concerning adaptive immunogenicity were available for at least one adaptive assay at one post-vaccination time point (up to Day 60).
Anti-HBs antibody concentrations in serum were measured by Chemi Luminiscence Immuno Assay (CLIA). Concentrations were presented as geometric mean concentrations, in milli-International Units per milliliter (mIU/mL).
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=25 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 1
Anti-HBs, PRE (D0)
|
3.1 mIU/mL
Interval 3.1 to 3.1
|
3.1 mIU/mL
Interval 3.1 to 3.1
|
|
Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 1
Anti-HBs, PII (D60)
|
3322.4 mIU/mL
Interval 2332.2 to 4733.0
|
35.8 mIU/mL
Interval 11.6 to 111.1
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-placebo (PP) and post-vaccination period following each vaccine dose (D1 and D2) and across dosesPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented, who have filled in their symptom sheets.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Any swelling, Across Doses
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Grade 3 swelling, Across Doses
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Any pain, PP
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Grade 3 pain, PP
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Any redness, PP
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Grade 3 redness, PP
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Any swelling, PP
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Grade 3 swelling, PP
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Any pain, D1
|
18 Participants
|
7 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Grade 3 pain, D1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Any redness, D1
|
6 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Grade 3 redness, D1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Any swelling, D1
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Grade 3 swelling, D1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Any pain, D2
|
15 Participants
|
6 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Grade 3 pain, D2
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Any redness, D2
|
5 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Grade 3 redness, D2
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Any swelling, D2
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Grade 3 swelling, D2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Any pain, Across Doses
|
21 Participants
|
8 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Grade 3 pain, Across Doses
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Any redness, Across Doses
|
8 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Grade 3 redness, Across Doses
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-placebo (PP) and post-vaccination period following each vaccine dose (D1 and D2) and across dosesPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented, who have filled in their symptom sheets.
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms \[nausea, vomiting, diarrhoea and /or abdominal pain\], headache, malaise, myalgia, shivering and temperature \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any fatigue, PP
|
8 Participants
|
12 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 fatigue, PP
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related fatigue, PP
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any gastrointestinal symptoms, PP
|
8 Participants
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 gastrointestinal symptoms, PP
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related gastrointestinal symptoms, PP
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any headache, PP
|
11 Participants
|
13 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 headache, PP
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related headache, PP
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any malaise, PP
|
3 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 malaise, PP
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related malaise, PP
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any myalgia, PP
|
2 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 myalgia, PP
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related myalgia, PP
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any shivering, PP
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 shivering, PP
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related shivering, PP
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any temperature, PP
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 temperature, PP
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related temperature, PP
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any Fatigue, D1
|
3 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 fatigue, D1
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related fatigue, D1
|
2 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any gastrointestinal symptoms, D1
|
4 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 gastrointestinal symptoms, D1
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related gastrointestinal symptoms, D1
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any headache, D1
|
14 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 headache, D1
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related headache, D1
|
11 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any malaise, D1
|
4 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 malaise, D1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related malaise, D1
|
4 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any myalgia, D1
|
10 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 myalgia, D1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related myalgia, D1
|
9 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any shivering, D1
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 shivering, D1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related shivering, D1
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any temperature (≥37.5 °C), D1
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 temperature (> 39.5 °C), D1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related temperature, D1
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any Fatigue, D2
|
10 Participants
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 fatigue, D2
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related fatigue, D2
|
10 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any gastrointestinal symptoms, D2
|
4 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 gastrointestinal symptoms, D2
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related gastrointestinal symptoms, D2
|
4 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any headache, D2
|
14 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 headache, D2
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related headache, D2
|
14 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any malaise, D2
|
7 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 malaise, D2
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related malaise, D2
|
7 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any myalgia, D2
|
10 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 myalgia, D2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related myalgia, D2
|
10 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any shivering, D2
|
9 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 shivering, D2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related shivering, D2
|
9 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any temperature (≥37.5 °C), D2
|
5 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 temperature (> 39.5 °C), D2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related temperature, D2
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any Fatigue, Across Doses
|
10 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 fatigue, Across Doses
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related fatigue, Across Doses
|
10 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any gastrointestinal symptoms, Across Doses
|
8 Participants
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 gastrointestinal symptoms, Across Doses
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related gastrointestinal symptoms, Across Doses
|
8 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any headache, Across Doses
|
17 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 headache, Across Doses
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related headache, Across Doses
|
15 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any malaise, Across Doses
|
8 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 malaise, Across Doses
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related malaise, Across Doses
|
8 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any myalgia, Across Doses
|
14 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 myalgia, Across Doses
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related myalgia, Across Doses
|
13 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any shivering, Across Doses
|
10 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 shivering, Across Doses
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related shivering, Across Doses
|
10 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any temperature (≥37.5 °C), Across Doses
|
6 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 temperature (> 39.5 °C), Across Doses
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related temperature, Across Doses
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 4 days post-placebo/vaccine administration.Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Assessed solicited symptoms were fever \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], pain, redness \[spreading beyond 20 millimeters (mm) of injection site\], induration \[spreading beyond 20 millimeters (mm) of injection site\], swelling \[spreading beyond 20 millimeters (mm) of injection site\] and muscle stiffness.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1
Swelling, D1
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1
Swelling, D2
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1
Muscle stiffness, placebo
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1
Muscle stiffness, D1
|
14 Participants
|
5 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1
Muscle stiffness, D2
|
15 Participants
|
4 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1
Fever (≥37.5), placebo
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1
Fever (≥37.5), D1
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1
Fever (≥37.5), D2
|
8 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1
Pain, placebo
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1
Pain, D1
|
19 Participants
|
9 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1
Pain, D2
|
19 Participants
|
8 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1
Redness, placebo
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1
Redness, D1
|
8 Participants
|
1 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1
Redness, D2
|
7 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1
Induration, placebo
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1
Induration, D1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1
Induration, D2
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1
Swelling, placebo
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within the 28-day (Days 0-27) post-placebo (PP) and post-product administration period.Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs) - Step 1
Any AEs, post-placebo
|
12 Participants
|
16 Participants
|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs) - Step 1
Any AEs, post-product administration
|
14 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: From Day 0 up to Day 60 for the HBsAg/AS_1 Group and from Day 0 up to Day 210 for the Engerix-B_1 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs) - Step 1
Day 210 SAEs
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Serious Adverse Events (SAEs) - Step 1
Day 60 SAEs
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 0 up to Day 60 for the HBsAg/AS_1 Group and from Day 0 up to Day 210 for the Engerix-B_1 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
PIMD(s) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Number of Subjects With Any Potential Immune-mediated Disorders (pIMDs) - Step 1
pIMDs - Day 60
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Potential Immune-mediated Disorders (pIMDs) - Step 1
pIMDs - Day 210
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 0 up to Day 60 for the HBsAg/AS_1 Group and from Day 0 up to Day 210 for the Engerix-B_1 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Number of Subjects With Any New Medical Conditions Requiring Medical Attention (MAEs) - Step 1
MAEs - Day 60
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any New Medical Conditions Requiring Medical Attention (MAEs) - Step 1
MAEs - Day 210
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Biochemical laboratory parameters assessed included ALT levels. ALT concentrations were expressed in units per liter (U/L). ALT levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=28 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=29 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1
ALT, Dose 1, Day 0
|
27.5 U/L
Interval 22.5 to 32.5
|
27 U/L
Interval 23.0 to 31.0
|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1
ALT, Dose 1 (Day 0 H6)
|
26.5 U/L
Interval 22.0 to 33.0
|
26 U/L
Interval 22.0 to 34.0
|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1
ALT, Dose 1 (Day 0 H12)
|
27 U/L
Interval 23.5 to 31.5
|
26 U/L
Interval 24.0 to 33.0
|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1
ALT, Dose 1 (Day 0 H18)
|
28 U/L
Interval 25.0 to 35.0
|
24 U/L
Interval 16.0 to 48.0
|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1
ALT, Dose 1, Day 1
|
25.5 U/L
Interval 20.0 to 33.0
|
27 U/L
Interval 20.0 to 35.0
|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1
ALT, Dose 1, Day 7
|
26.5 U/L
Interval 22.0 to 32.5
|
28 U/L
Interval 19.0 to 34.0
|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1
ALT, Dose 2, Day 30
|
27 U/L
Interval 22.0 to 36.0
|
30 U/L
Interval 24.0 to 33.0
|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1
ALT, Dose 2 (Day 30 H6)
|
27 U/L
Interval 23.0 to 34.0
|
28 U/L
Interval 25.0 to 32.0
|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1
ALT, Dose 2 (Day 30 H12)
|
27 U/L
Interval 24.0 to 34.0
|
28 U/L
Interval 23.0 to 33.5
|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1
ALT, Dose 2 (Day 30 H18)
|
32 U/L
Interval 25.0 to 37.0
|
26 U/L
Interval 24.0 to 46.0
|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1
ALT, Dose 2, Day 31
|
27 U/L
Interval 22.0 to 33.0
|
27 U/L
Interval 23.0 to 34.0
|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1
ALT, Dose 2, Day 37
|
27 U/L
Interval 22.0 to 30.0
|
26 U/L
Interval 23.5 to 33.0
|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1
ALT, Dose 2, Day 60
|
28 U/L
Interval 23.0 to 32.0
|
28 U/L
Interval 22.5 to 36.0
|
SECONDARY outcome
Timeframe: At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Biochemical laboratory parameters assessed included AST levels. AST concentrations were expressed in units per liter (U/L). AST levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=28 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=29 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1
AST, Dose 1, Day 0
|
21 U/L
Interval 18.0 to 26.0
|
23 U/L
Interval 18.0 to 25.0
|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1
AST, Dose 1 (Day 0 H6)
|
20.5 U/L
Interval 18.5 to 24.0
|
21 U/L
Interval 17.0 to 25.0
|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1
AST, Dose 1 (Day 0 H12)
|
20 U/L
Interval 18.5 to 22.5
|
20 U/L
Interval 17.0 to 25.0
|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1
AST, Dose 1 (Day 0 H18)
|
19 U/L
Interval 15.0 to 24.0
|
18 U/L
Interval 17.0 to 28.0
|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1
AST, Dose 1, Day 1
|
19 U/L
Interval 16.0 to 22.5
|
20 U/L
Interval 18.0 to 23.0
|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1
AST, Dose 1, Day 7
|
21 U/L
Interval 18.5 to 25.5
|
21 U/L
Interval 18.0 to 29.0
|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1
AST, Dose 2, Day 30
|
21 U/L
Interval 19.0 to 26.0
|
23 U/L
Interval 19.0 to 25.0
|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1
AST, Dose 2 (Day 30 H6)
|
21 U/L
Interval 19.0 to 24.0
|
22 U/L
Interval 20.0 to 25.5
|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1
AST, Dose 2 (Day 30 H12)
|
20 U/L
Interval 18.0 to 25.0
|
21 U/L
Interval 20.0 to 24.5
|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1
AST, Dose 2 (Day 30 H18)
|
20 U/L
Interval 19.0 to 22.0
|
19.5 U/L
Interval 16.0 to 30.0
|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1
AST, Dose 2, Day 31
|
19 U/L
Interval 17.0 to 23.0
|
21 U/L
Interval 18.0 to 25.5
|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1
AST, Dose 2, Day 37
|
22 U/L
Interval 19.0 to 25.0
|
23 U/L
Interval 18.0 to 29.5
|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1
AST, Dose 2, Day 60
|
21 U/L
Interval 18.0 to 26.0
|
21.5 U/L
Interval 18.0 to 28.5
|
SECONDARY outcome
Timeframe: At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Haematological laboratory parameters assessed included basophil levels. Basophil levels were expressed in billion cells per liter (billion cells/L). Basophil levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=28 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=29 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Basophils in Blood Samples - Step 1
Basophils, Dose 1, Day 0
|
0.03 billion cells/L
Interval 0.02 to 0.04
|
0.02 billion cells/L
Interval 0.02 to 0.03
|
|
Levels of Basophils in Blood Samples - Step 1
Basophils, Dose 1 (Day 0 H6)
|
0.03 billion cells/L
Interval 0.02 to 0.04
|
0.03 billion cells/L
Interval 0.02 to 0.03
|
|
Levels of Basophils in Blood Samples - Step 1
Basophils, Dose 1 (Day 0 H12)
|
0.03 billion cells/L
Interval 0.02 to 0.05
|
0.02 billion cells/L
Interval 0.02 to 0.03
|
|
Levels of Basophils in Blood Samples - Step 1
Basophils, Dose 1 (Day 0 H18)
|
0.03 billion cells/L
Interval 0.01 to 0.03
|
0.02 billion cells/L
Interval 0.01 to 0.03
|
|
Levels of Basophils in Blood Samples - Step 1
Basophils, Dose 1, Day 1
|
0.03 billion cells/L
Interval 0.01 to 0.04
|
0.02 billion cells/L
Interval 0.02 to 0.03
|
|
Levels of Basophils in Blood Samples - Step 1
Basophils, Dose 1, Day 7
|
0.03 billion cells/L
Interval 0.02 to 0.04
|
0.03 billion cells/L
Interval 0.02 to 0.04
|
|
Levels of Basophils in Blood Samples - Step 1
Basophils, Dose 2, Day 30
|
0.03 billion cells/L
Interval 0.02 to 0.04
|
0.02 billion cells/L
Interval 0.02 to 0.04
|
|
Levels of Basophils in Blood Samples - Step 1
Basophils, Dose 2 (Day 30 H6)
|
0.03 billion cells/L
Interval 0.02 to 0.04
|
0.02 billion cells/L
Interval 0.02 to 0.03
|
|
Levels of Basophils in Blood Samples - Step 1
Basophils, Dose 2 (Day 30 H12)
|
0.02 billion cells/L
Interval 0.01 to 0.03
|
0.02 billion cells/L
Interval 0.02 to 0.04
|
|
Levels of Basophils in Blood Samples - Step 1
Basophils, Dose 2 (Day 30 H18)
|
0.03 billion cells/L
Interval 0.01 to 0.03
|
0.02 billion cells/L
Interval 0.01 to 0.03
|
|
Levels of Basophils in Blood Samples - Step 1
Basophils, Dose 2, Day 31
|
0.02 billion cells/L
Interval 0.01 to 0.03
|
0.03 billion cells/L
Interval 0.02 to 0.04
|
|
Levels of Basophils in Blood Samples - Step 1
Basophils, Dose 2, Day 37
|
0.03 billion cells/L
Interval 0.02 to 0.06
|
0.03 billion cells/L
Interval 0.02 to 0.03
|
|
Levels of Basophils in Blood Samples - Step 1
Basophils, Dose 2, Day 60
|
0.03 billion cells/L
Interval 0.02 to 0.04
|
0.03 billion cells/L
Interval 0.02 to 0.03
|
SECONDARY outcome
Timeframe: At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Biochemical laboratory parameters assessed included total bilirubin levels. Bilirubin concentrations were expressed in milligrams per deciliter (mG/dL). Bilirubin levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=28 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=29 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Total Bilirubin in Blood Samples - Step 1
Total bilirubin, Dose 1, Day 0
|
0.5 mg/dL
Interval 0.4 to 0.7
|
0.5 mg/dL
Interval 0.3 to 0.7
|
|
Levels of Total Bilirubin in Blood Samples - Step 1
Total bilirubin, Dose 1 (Day 0 H6)
|
0.4 mg/dL
Interval 0.25 to 0.5
|
0.4 mg/dL
Interval 0.3 to 0.5
|
|
Levels of Total Bilirubin in Blood Samples - Step 1
Total bilirubin, Dose 1 (Day 0 H12)
|
0.4 mg/dL
Interval 0.3 to 0.6
|
0.3 mg/dL
Interval 0.3 to 0.5
|
|
Levels of Total Bilirubin in Blood Samples - Step 1
Total bilirubin, Dose 1 (Day 0 H18)
|
0.6 mg/dL
Interval 0.4 to 0.8
|
0.5 mg/dL
Interval 0.3 to 0.6
|
|
Levels of Total Bilirubin in Blood Samples - Step 1
Total bilirubin, Dose 1, Day 1
|
0.7 mg/dL
Interval 0.6 to 0.9
|
0.5 mg/dL
Interval 0.3 to 0.8
|
|
Levels of Total Bilirubin in Blood Samples - Step 1
Total bilirubin, Dose 1, Day 7
|
0.5 mg/dL
Interval 0.4 to 0.7
|
0.5 mg/dL
Interval 0.3 to 0.6
|
|
Levels of Total Bilirubin in Blood Samples - Step 1
Total bilirubin, Dose 2, Day 30
|
0.6 mg/dL
Interval 0.4 to 0.7
|
0.5 mg/dL
Interval 0.4 to 0.7
|
|
Levels of Total Bilirubin in Blood Samples - Step 1
Total bilirubin, Dose 2 (Day 30 H6)
|
0.4 mg/dL
Interval 0.3 to 0.5
|
0.4 mg/dL
Interval 0.3 to 0.5
|
|
Levels of Total Bilirubin in Blood Samples - Step 1
Total bilirubin, Dose 2 (Day 30 H12)
|
0.5 mg/dL
Interval 0.4 to 0.6
|
0.4 mg/dL
Interval 0.3 to 0.5
|
|
Levels of Total Bilirubin in Blood Samples - Step 1
Total bilirubin, Dose 2 (Day 30 H18)
|
0.6 mg/dL
Interval 0.4 to 0.7
|
0.45 mg/dL
Interval 0.3 to 0.5
|
|
Levels of Total Bilirubin in Blood Samples - Step 1
Total bilirubin, Dose 2, Day 31
|
0.7 mg/dL
Interval 0.5 to 1.0
|
0.5 mg/dL
Interval 0.45 to 0.7
|
|
Levels of Total Bilirubin in Blood Samples - Step 1
Total bilirubin, Dose 2, Day 37
|
0.5 mg/dL
Interval 0.3 to 0.8
|
0.5 mg/dL
Interval 0.4 to 0.65
|
|
Levels of Total Bilirubin in Blood Samples - Step 1
Total bilirubin, Dose 2, Day 60
|
0.5 mg/dL
Interval 0.4 to 0.6
|
0.5 mg/dL
Interval 0.4 to 0.6
|
SECONDARY outcome
Timeframe: At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Biochemical laboratory parameters assessed included creatinine levels. Creatinine concentrations were expressed in milligrams per deciliter (mg/dL). Creatinine levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=28 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=29 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Serum Creatinine in Blood Samples - Step 1
Creatinine, Dose 1, Day 0
|
0.8 mg/dL
Interval 0.75 to 0.93
|
0.79 mg/dL
Interval 0.72 to 0.85
|
|
Levels of Serum Creatinine in Blood Samples - Step 1
Creatinine, Dose 1 (Day 0 H6)
|
0.75 mg/dL
Interval 0.66 to 0.85
|
0.72 mg/dL
Interval 0.69 to 0.82
|
|
Levels of Serum Creatinine in Blood Samples - Step 1
Creatinine, Dose 1 (Day 0 H12)
|
0.78 mg/dL
Interval 0.66 to 0.83
|
0.73 mg/dL
Interval 0.68 to 0.83
|
|
Levels of Serum Creatinine in Blood Samples - Step 1
Creatinine, Dose 1 (Day 0 H18)
|
0.7 mg/dL
Interval 0.61 to 0.77
|
0.71 mg/dL
Interval 0.63 to 0.84
|
|
Levels of Serum Creatinine in Blood Samples - Step 1
Creatinine, Dose 1, Day 1
|
0.74 mg/dL
Interval 0.68 to 0.91
|
0.77 mg/dL
Interval 0.71 to 0.85
|
|
Levels of Serum Creatinine in Blood Samples - Step 1
Creatinine, Dose 1, Day 7
|
0.81 mg/dL
Interval 0.71 to 0.93
|
0.76 mg/dL
Interval 0.69 to 0.87
|
|
Levels of Serum Creatinine in Blood Samples - Step 1
Creatinine, Dose 2, Day 30
|
0.82 mg/dL
Interval 0.74 to 0.96
|
0.79 mg/dL
Interval 0.72 to 0.83
|
|
Levels of Serum Creatinine in Blood Samples - Step 1
Creatinine, Dose 2 (Day 30 H6)
|
0.75 mg/dL
Interval 0.68 to 0.85
|
0.73 mg/dL
Interval 0.67 to 0.83
|
|
Levels of Serum Creatinine in Blood Samples - Step 1
Creatinine, Dose 2 (Day 30 H12)
|
0.76 mg/dL
Interval 0.68 to 0.85
|
0.72 mg/dL
Interval 0.69 to 0.82
|
|
Levels of Serum Creatinine in Blood Samples - Step 1
Creatinine, Dose 2 (Day 30 H18)
|
0.74 mg/dL
Interval 0.68 to 0.81
|
0.73 mg/dL
Interval 0.65 to 0.82
|
|
Levels of Serum Creatinine in Blood Samples - Step 1
Creatinine, Dose 2, Day 31
|
0.79 mg/dL
Interval 0.69 to 0.93
|
0.76 mg/dL
Interval 0.7 to 0.87
|
|
Levels of Serum Creatinine in Blood Samples - Step 1
Creatinine, Dose 2, Day 37
|
0.81 mg/dL
Interval 0.73 to 0.93
|
0.73 mg/dL
Interval 0.7 to 0.9
|
|
Levels of Serum Creatinine in Blood Samples - Step 1
Creatinine, Dose 2, Day 60
|
0.84 mg/dL
Interval 0.69 to 0.97
|
0.78 mg/dL
Interval 0.72 to 0.91
|
SECONDARY outcome
Timeframe: At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Biochemical laboratory parameters assessed included CPK levels. CPK concentrations were expressed in milligrams per deciliter (mg/dL). CPK levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=28 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=29 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1
CPK, Dose 1, Day 0
|
75 mg/dL
Interval 56.5 to 108.0
|
80 mg/dL
Interval 62.0 to 148.0
|
|
Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1
CPK, Dose 1 (Day 0 H6
|
69.5 mg/dL
Interval 53.0 to 106.0
|
75 mg/dL
Interval 60.0 to 120.0
|
|
Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1
CPK, Dose 1 (Day 0 H12)
|
64.5 mg/dL
Interval 51.0 to 94.5
|
77 mg/dL
Interval 57.0 to 110.0
|
|
Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1
CPK, Dose 1 (Day 0 H18)
|
59 mg/dL
Interval 49.0 to 90.0
|
61 mg/dL
Interval 44.0 to 103.0
|
|
Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1
CPK, Dose 1, Day 1
|
54 mg/dL
Interval 42.5 to 79.5
|
69 mg/dL
Interval 46.0 to 96.0
|
|
Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1
CPK, Dose 1, Day 7
|
66 mg/dL
Interval 55.5 to 95.0
|
80 mg/dL
Interval 57.0 to 117.0
|
|
Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1
CPK, Dose 2, Day 30
|
83 mg/dL
Interval 48.0 to 122.0
|
87 mg/dL
Interval 55.0 to 145.0
|
|
Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1
CPK, Dose 2 (Day 30 H6)
|
81 mg/dL
Interval 45.0 to 108.0
|
86 mg/dL
Interval 53.5 to 140.5
|
|
Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1
CPK, Dose 2 (Day 30 H12)
|
72 mg/dL
Interval 50.0 to 98.0
|
80.5 mg/dL
Interval 54.0 to 134.0
|
|
Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1
CPK, Dose 2 (Day 30 H18)
|
68.5 mg/dL
Interval 53.0 to 103.0
|
70 mg/dL
Interval 37.0 to 120.0
|
|
Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1
CPK, Dose 2, Day 31
|
67 mg/dL
Interval 44.0 to 87.0
|
75 mg/dL
Interval 50.0 to 119.0
|
|
Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1
CPK, Dose 2, Day 37
|
83 mg/dL
Interval 59.0 to 119.0
|
93.5 mg/dL
Interval 54.0 to 115.5
|
|
Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1
CPK, Dose 2, Day 60
|
82 mg/dL
Interval 55.0 to 118.0
|
82.5 mg/dL
Interval 62.0 to 122.0
|
SECONDARY outcome
Timeframe: At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Biochemical laboratory parameters assessed included CRP levels. CRP concentrations were expressed in milligrams per liter (mg/L). CRP levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=28 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=29 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of C-reactive Protein (CRP) in Blood Samples - Step 1
CRP, Dose 1, Day 0
|
1.15 mg/L
Interval 0.5 to 3.0
|
1.7 mg/L
Interval 0.5 to 2.5
|
|
Levels of C-reactive Protein (CRP) in Blood Samples - Step 1
CRP, Dose 1 (Day 0 H6)
|
0.8 mg/L
Interval 0.5 to 2.9
|
1.6 mg/L
Interval 0.5 to 2.4
|
|
Levels of C-reactive Protein (CRP) in Blood Samples - Step 1
CRP, Dose 1 (Day 0 H12)
|
1.5 mg/L
Interval 0.5 to 3.35
|
1.4 mg/L
Interval 0.5 to 2.1
|
|
Levels of C-reactive Protein (CRP) in Blood Samples - Step 1
CRP, Dose 1 (Day 0 H18)
|
2.9 mg/L
Interval 1.5 to 4.4
|
1.25 mg/L
Interval 0.5 to 1.8
|
|
Levels of C-reactive Protein (CRP) in Blood Samples - Step 1
CRP, Dose 1, Day 1
|
5.8 mg/L
Interval 3.1 to 11.1
|
1.2 mg/L
Interval 0.5 to 1.8
|
|
Levels of C-reactive Protein (CRP) in Blood Samples - Step 1
CRP, Dose 1, Day 7
|
1.9 mg/L
Interval 0.5 to 4.25
|
1.3 mg/L
Interval 0.5 to 2.6
|
|
Levels of C-reactive Protein (CRP) in Blood Samples - Step 1
CRP, Dose 2, Day 30
|
1.3 mg/L
Interval 0.5 to 4.3
|
1.4 mg/L
Interval 0.5 to 3.1
|
|
Levels of C-reactive Protein (CRP) in Blood Samples - Step 1
CRP, Dose 2 (Day 30 H6)
|
1.2 mg/L
Interval 0.5 to 2.3
|
1.5 mg/L
Interval 0.5 to 3.05
|
|
Levels of C-reactive Protein (CRP) in Blood Samples - Step 1
CRP, Dose 2 (Day 30 H12)
|
1.8 mg/L
Interval 0.5 to 2.8
|
1.55 mg/L
Interval 0.5 to 3.1
|
|
Levels of C-reactive Protein (CRP) in Blood Samples - Step 1
CRP, Dose 2 (Day 30 H18)
|
3.15 mg/L
Interval 2.1 to 5.3
|
0.75 mg/L
Interval 0.5 to 2.8
|
|
Levels of C-reactive Protein (CRP) in Blood Samples - Step 1
CRP, Dose 2, Day 31
|
5.8 mg/L
Interval 2.6 to 14.5
|
1.2 mg/L
Interval 0.5 to 2.65
|
|
Levels of C-reactive Protein (CRP) in Blood Samples - Step 1
CRP, Dose 2, Day 37
|
2.1 mg/L
Interval 1.1 to 5.8
|
1.3 mg/L
Interval 0.5 to 2.95
|
|
Levels of C-reactive Protein (CRP) in Blood Samples - Step 1
CRP, Dose 2, Day 60
|
1.4 mg/L
Interval 0.5 to 3.9
|
1.05 mg/L
Interval 0.5 to 3.85
|
SECONDARY outcome
Timeframe: At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Haematological laboratory parameters assessed included eosinophil levels. Eosinophil levels were expressed in billion cells per liter (billion cells/L). Eosinophil levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=28 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=29 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Eosinophils in Blood Samples - Step 1
Eosinophils, Dose 1, Day 0
|
0.2 billion cells/L
Interval 0.11 to 0.25
|
0.13 billion cells/L
Interval 0.1 to 0.21
|
|
Levels of Eosinophils in Blood Samples - Step 1
Eosinophils, Dose 1 (Day 0 H6)
|
0.19 billion cells/L
Interval 0.13 to 0.27
|
0.13 billion cells/L
Interval 0.09 to 0.21
|
|
Levels of Eosinophils in Blood Samples - Step 1
Eosinophils, Dose 1 (Day 0 H12)
|
0.21 billion cells/L
Interval 0.15 to 0.27
|
0.17 billion cells/L
Interval 0.12 to 0.21
|
|
Levels of Eosinophils in Blood Samples - Step 1
Eosinophils, Dose 1 (Day 0 H18)
|
0.16 billion cells/L
Interval 0.12 to 0.3
|
0.2 billion cells/L
Interval 0.16 to 0.31
|
|
Levels of Eosinophils in Blood Samples - Step 1
Eosinophils, Dose 1, Day 1
|
0.15 billion cells/L
Interval 0.08 to 0.25
|
0.1 billion cells/L
Interval 0.07 to 0.2
|
|
Levels of Eosinophils in Blood Samples - Step 1
Eosinophils, Dose 1, Day 7
|
0.14 billion cells/L
Interval 0.08 to 0.2
|
0.11 billion cells/L
Interval 0.09 to 0.17
|
|
Levels of Eosinophils in Blood Samples - Step 1
Eosinophils, Dose 2, Day 30
|
0.18 billion cells/L
Interval 0.11 to 0.25
|
0.14 billion cells/L
Interval 0.09 to 0.26
|
|
Levels of Eosinophils in Blood Samples - Step 1
Eosinophils, Dose 2 (Day 30 H6)
|
0.18 billion cells/L
Interval 0.1 to 0.29
|
0.13 billion cells/L
Interval 0.09 to 0.22
|
|
Levels of Eosinophils in Blood Samples - Step 1
Eosinophils, Dose 2 (Day 30 H12)
|
0.19 billion cells/L
Interval 0.12 to 0.31
|
0.14 billion cells/L
Interval 0.09 to 0.24
|
|
Levels of Eosinophils in Blood Samples - Step 1
Eosinophils, Dose 2 (Day 30 H18)
|
0.14 billion cells/L
Interval 0.05 to 0.21
|
0.19 billion cells/L
Interval 0.12 to 0.32
|
|
Levels of Eosinophils in Blood Samples - Step 1
Eosinophils, Dose 2, Day 31
|
0.14 billion cells/L
Interval 0.05 to 0.2
|
0.13 billion cells/L
Interval 0.09 to 0.22
|
|
Levels of Eosinophils in Blood Samples - Step 1
Eosinophils, Dose 2, Day 37
|
0.19 billion cells/L
Interval 0.11 to 0.24
|
0.15 billion cells/L
Interval 0.09 to 0.23
|
|
Levels of Eosinophils in Blood Samples - Step 1
Eosinophils, Dose 2, Day 60
|
0.19 billion cells/L
Interval 0.1 to 0.28
|
0.14 billion cells/L
Interval 0.11 to 0.24
|
SECONDARY outcome
Timeframe: At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Haematological laboratory parameters assessed included haemoglobin levels, expressed in grams per deciliter (g/dL). Haemoglobin levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=28 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=29 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Haemoglobin in Blood Samples - Step 1
Haemoglobin, Dose 1, Day 7
|
13.35 g/dL
Interval 12.55 to 14.35
|
13.8 g/dL
Interval 12.8 to 14.6
|
|
Levels of Haemoglobin in Blood Samples - Step 1
Haemoglobin, Dose 2, Day 30
|
13.7 g/dL
Interval 12.7 to 14.3
|
13.4 g/dL
Interval 12.6 to 14.3
|
|
Levels of Haemoglobin in Blood Samples - Step 1
Haemoglobin, Dose 2 (Day 30 H6)
|
13.4 g/dL
Interval 12.5 to 14.0
|
13.55 g/dL
Interval 12.45 to 14.15
|
|
Levels of Haemoglobin in Blood Samples - Step 1
Haemoglobin, Dose 2 (Day 30 H12)
|
13.2 g/dL
Interval 12.6 to 14.1
|
13.1 g/dL
Interval 12.4 to 14.15
|
|
Levels of Haemoglobin in Blood Samples - Step 1
Haemoglobin, Dose 2 (Day 30 H18)
|
13.15 g/dL
Interval 11.7 to 13.9
|
13.05 g/dL
Interval 12.3 to 14.1
|
|
Levels of Haemoglobin in Blood Samples - Step 1
Haemoglobin, Dose 2, Day 31
|
13.5 g/dL
Interval 12.5 to 14.4
|
13.75 g/dL
Interval 12.65 to 14.6
|
|
Levels of Haemoglobin in Blood Samples - Step 1
Haemoglobin, Dose 1, Day 0
|
13.35 g/dL
Interval 12.7 to 14.5
|
13.8 g/dL
Interval 12.5 to 14.8
|
|
Levels of Haemoglobin in Blood Samples - Step 1
Haemoglobin, Dose 1 (Day 0 H6)
|
13.45 g/dL
Interval 12.3 to 14.05
|
13.6 g/dL
Interval 12.5 to 14.6
|
|
Levels of Haemoglobin in Blood Samples - Step 1
Haemoglobin, Dose 1 (Day 0 H12)
|
13.25 g/dL
Interval 12.3 to 14.3
|
13.2 g/dL
Interval 12.6 to 14.5
|
|
Levels of Haemoglobin in Blood Samples - Step 1
Haemoglobin, Dose 1 (Day 0 H18)
|
12.6 g/dL
Interval 12.0 to 13.9
|
13.15 g/dL
Interval 12.5 to 14.5
|
|
Levels of Haemoglobin in Blood Samples - Step 1
Haemoglobin, Dose 1, Day 1
|
13.5 g/dL
Interval 12.6 to 14.45
|
13.8 g/dL
Interval 12.9 to 14.7
|
|
Levels of Haemoglobin in Blood Samples - Step 1
Haemoglobin, Dose 2, Day 37
|
13.6 g/dL
Interval 12.6 to 14.5
|
13.65 g/dL
Interval 12.35 to 14.5
|
|
Levels of Haemoglobin in Blood Samples - Step 1
Haemoglobin, Dose 2, Day 60
|
13.5 g/dL
Interval 12.4 to 14.5
|
13.8 g/dL
Interval 12.2 to 14.5
|
SECONDARY outcome
Timeframe: At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Biochemical laboratory parameters assessed included LDH levels, expressed in units per liter (U/L). LDH levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=28 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=29 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1
LDH, Dose 1, Day 0
|
401.5 U/L
Interval 377.0 to 473.5
|
382 U/L
Interval 346.0 to 438.0
|
|
Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1
LDH, Dose 1 (Day 0 H6)
|
414 U/L
Interval 388.5 to 449.5
|
389 U/L
Interval 353.0 to 423.0
|
|
Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1
LDH, Dose 1 (Day 0 H12)
|
412 U/L
Interval 392.0 to 457.5
|
378 U/L
Interval 339.0 to 426.0
|
|
Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1
LDH, Dose 1 (Day 0 H18)
|
422 U/L
Interval 341.0 to 461.0
|
369.5 U/L
Interval 302.0 to 410.0
|
|
Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1
LDH, Dose 1, Day 1
|
389 U/L
Interval 352.0 to 466.0
|
367 U/L
Interval 342.0 to 411.0
|
|
Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1
LDH, Dose 1, Day 7
|
417.5 U/L
Interval 382.5 to 479.5
|
392 U/L
Interval 371.0 to 436.0
|
|
Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1
LDH, Dose 2, Day 30
|
391 U/L
Interval 360.0 to 456.0
|
395 U/L
Interval 348.0 to 426.0
|
|
Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1
LDH, Dose 2 (Day 30 H6)
|
437 U/L
Interval 397.0 to 470.0
|
396.5 U/L
Interval 350.5 to 428.0
|
|
Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1
LDH, Dose 2 (Day 30 H12)
|
425 U/L
Interval 403.0 to 470.0
|
382.5 U/L
Interval 338.5 to 424.0
|
|
Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1
LDH, Dose 2 (Day 30 H18)
|
403 U/L
Interval 365.0 to 450.0
|
334.5 U/L
Interval 297.0 to 390.0
|
|
Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1
LDH, Dose 2, Day 31
|
408 U/L
Interval 373.0 to 453.0
|
372 U/L
Interval 354.0 to 403.0
|
|
Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1
LDH, Dose 2, Day 37
|
442 U/L
Interval 412.0 to 464.0
|
403 U/L
Interval 368.5 to 446.0
|
|
Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1
LDH, Dose 2, Day 60
|
422 U/L
Interval 397.0 to 478.0
|
404 U/L
Interval 374.0 to 431.5
|
SECONDARY outcome
Timeframe: At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Haematological laboratory parameters assessed included lymphocyte levels. Lymphocyte levels were expressed in billion cells per liter (billion cells/L). Lymphocyte levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=28 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=29 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Lymphocytes in Blood Samples - Step 1
Lymphocytes, Dose 2, Day 30
|
1.67 billion cells/L
Interval 1.36 to 2.03
|
1.97 billion cells/L
Interval 1.64 to 2.5
|
|
Levels of Lymphocytes in Blood Samples - Step 1
Lymphocytes, Dose 2 (Day 30 H6)
|
1.81 billion cells/L
Interval 1.56 to 2.16
|
2.11 billion cells/L
Interval 1.78 to 2.59
|
|
Levels of Lymphocytes in Blood Samples - Step 1
Lymphocytes, Dose 1, Day 0
|
1.84 billion cells/L
Interval 1.45 to 1.98
|
1.99 billion cells/L
Interval 1.61 to 2.26
|
|
Levels of Lymphocytes in Blood Samples - Step 1
Lymphocytes, Dose 1 (Day 0 H6)
|
1.89 billion cells/L
Interval 1.48 to 2.35
|
2.07 billion cells/L
Interval 1.52 to 2.46
|
|
Levels of Lymphocytes in Blood Samples - Step 1
Lymphocytes, Dose 1 (Day 0 H12)
|
1.97 billion cells/L
Interval 1.72 to 2.33
|
2.39 billion cells/L
Interval 2.0 to 2.97
|
|
Levels of Lymphocytes in Blood Samples - Step 1
Lymphocytes, Dose 1 (Day 0 H18)
|
1.73 billion cells/L
Interval 1.41 to 2.48
|
3.08 billion cells/L
Interval 2.45 to 3.53
|
|
Levels of Lymphocytes in Blood Samples - Step 1
Lymphocytes, Dose 1, Day 1
|
1.58 billion cells/L
Interval 1.25 to 1.83
|
1.94 billion cells/L
Interval 1.66 to 2.26
|
|
Levels of Lymphocytes in Blood Samples - Step 1
Lymphocytes, Dose 1, Day 7
|
1.69 billion cells/L
Interval 1.37 to 1.91
|
1.97 billion cells/L
Interval 1.56 to 2.17
|
|
Levels of Lymphocytes in Blood Samples - Step 1
Lymphocytes, Dose 2 (Day 30 H12)
|
1.9 billion cells/L
Interval 1.36 to 2.39
|
2.35 billion cells/L
Interval 2.1 to 2.82
|
|
Levels of Lymphocytes in Blood Samples - Step 1
Lymphocytes, Dose 2 (Day 30 H18)
|
1.46 billion cells/L
Interval 1.06 to 1.83
|
2.99 billion cells/L
Interval 2.45 to 3.53
|
|
Levels of Lymphocytes in Blood Samples - Step 1
Lymphocytes, Dose 2, Day 31
|
1.19 billion cells/L
Interval 0.89 to 1.43
|
2.01 billion cells/L
Interval 1.75 to 2.5
|
|
Levels of Lymphocytes in Blood Samples - Step 1
Lymphocytes, Dose 2, Day 37
|
1.74 billion cells/L
Interval 1.41 to 2.21
|
2.01 billion cells/L
Interval 1.64 to 2.36
|
|
Levels of Lymphocytes in Blood Samples - Step 1
Lymphocytes, Dose 2, Day 60
|
1.76 billion cells/L
Interval 1.4 to 2.29
|
2.09 billion cells/L
Interval 1.73 to 2.31
|
SECONDARY outcome
Timeframe: At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Haematological laboratory parameters assessed included monocyte levels. Monocyte levels were expressed in billion cells per liter (billion cells/L). Monocyte levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=28 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=29 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Monocytes in Blood Samples - Step 1
Monocytes, Dose 1, Day 0
|
0.55 billion cells/L
Interval 0.45 to 0.66
|
0.55 billion cells/L
Interval 0.4 to 0.62
|
|
Levels of Monocytes in Blood Samples - Step 1
Monocytes, Dose 1 (Day 0 H6)
|
0.67 billion cells/L
Interval 0.59 to 0.76
|
0.52 billion cells/L
Interval 0.4 to 0.55
|
|
Levels of Monocytes in Blood Samples - Step 1
Monocytes, Dose 1 (Day 0 H12)
|
0.79 billion cells/L
Interval 0.62 to 0.9
|
0.53 billion cells/L
Interval 0.41 to 0.6
|
|
Levels of Monocytes in Blood Samples - Step 1
Monocytes, Dose 1 (Day 0 H18)
|
0.79 billion cells/L
Interval 0.66 to 0.92
|
0.59 billion cells/L
Interval 0.5 to 0.61
|
|
Levels of Monocytes in Blood Samples - Step 1
Monocytes, Dose 1, Day 1
|
0.72 billion cells/L
Interval 0.6 to 0.84
|
0.45 billion cells/L
Interval 0.4 to 0.54
|
|
Levels of Monocytes in Blood Samples - Step 1
Monocytes, Dose 1, Day 7
|
0.54 billion cells/L
Interval 0.43 to 0.63
|
0.44 billion cells/L
Interval 0.37 to 0.58
|
|
Levels of Monocytes in Blood Samples - Step 1
Monocytes, Dose 2, Day 30
|
0.55 billion cells/L
Interval 0.47 to 0.65
|
0.5 billion cells/L
Interval 0.43 to 0.63
|
|
Levels of Monocytes in Blood Samples - Step 1
Monocytes, Dose 2 (Day 30 H6)
|
0.67 billion cells/L
Interval 0.54 to 0.78
|
0.48 billion cells/L
Interval 0.4 to 0.56
|
|
Levels of Monocytes in Blood Samples - Step 1
Monocytes, Dose 2 (Day 30 H12)
|
0.66 billion cells/L
Interval 0.57 to 0.87
|
0.51 billion cells/L
Interval 0.39 to 0.61
|
|
Levels of Monocytes in Blood Samples - Step 1
Monocytes, Dose 2 (Day 30 H18)
|
0.8 billion cells/L
Interval 0.62 to 0.94
|
0.49 billion cells/L
Interval 0.43 to 0.59
|
|
Levels of Monocytes in Blood Samples - Step 1
Monocytes, Dose 2, Day 31
|
0.67 billion cells/L
Interval 0.53 to 0.81
|
0.51 billion cells/L
Interval 0.44 to 0.67
|
|
Levels of Monocytes in Blood Samples - Step 1
Monocytes, Dose 2, Day 37
|
0.51 billion cells/L
Interval 0.39 to 0.64
|
0.51 billion cells/L
Interval 0.44 to 0.59
|
|
Levels of Monocytes in Blood Samples - Step 1
Monocytes, Dose 2, Day 60
|
0.51 billion cells/L
Interval 0.39 to 0.68
|
0.52 billion cells/L
Interval 0.44 to 0.64
|
SECONDARY outcome
Timeframe: At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Haematological laboratory parameters assessed included neutrophil levels. Neutrophil levels were expressed in billion cells per liter (billion cells/L). Neutrophil levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=28 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=29 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Neutrophils in Blood Samples - Step 1
Neutrophils, Dose 1, Day 1
|
6.13 billion cells/L
Interval 4.26 to 6.76
|
3.76 billion cells/L
Interval 3.12 to 4.23
|
|
Levels of Neutrophils in Blood Samples - Step 1
Neutrophils, Dose 1, Day 7
|
4.17 billion cells/L
Interval 3.05 to 5.17
|
3.46 billion cells/L
Interval 2.73 to 4.19
|
|
Levels of Neutrophils in Blood Samples - Step 1
Neutrophils, Dose 2, Day 30
|
3.66 billion cells/L
Interval 3.08 to 4.49
|
2.91 billion cells/L
Interval 2.43 to 3.91
|
|
Levels of Neutrophils in Blood Samples - Step 1
Neutrophils, Dose 2 (Day 30 H6)
|
5.9 billion cells/L
Interval 5.28 to 7.75
|
3.39 billion cells/L
Interval 2.93 to 4.07
|
|
Levels of Neutrophils in Blood Samples - Step 1
Neutrophils, Dose 2 (Day 30 H12)
|
7.07 billion cells/L
Interval 6.47 to 8.58
|
3.36 billion cells/L
Interval 2.59 to 4.12
|
|
Levels of Neutrophils in Blood Samples - Step 1
Neutrophils, Dose 1, Day 0
|
3.7 billion cells/L
Interval 3.0 to 5.49
|
3.36 billion cells/L
Interval 2.77 to 4.21
|
|
Levels of Neutrophils in Blood Samples - Step 1
Neutrophils, Dose 1 (Day 0 H6)
|
6.48 billion cells/L
Interval 5.02 to 7.84
|
4.12 billion cells/L
Interval 2.96 to 4.41
|
|
Levels of Neutrophils in Blood Samples - Step 1
Neutrophils, Dose 2 (Day 30 H18)
|
7.42 billion cells/L
Interval 6.84 to 9.35
|
3.02 billion cells/L
Interval 2.39 to 3.74
|
|
Levels of Neutrophils in Blood Samples - Step 1
Neutrophils, Dose 2, Day 31
|
6.32 billion cells/L
Interval 4.78 to 7.41
|
3.2 billion cells/L
Interval 2.77 to 4.9
|
|
Levels of Neutrophils in Blood Samples - Step 1
Neutrophils, Dose 2, Day 37
|
3.64 billion cells/L
Interval 2.73 to 5.48
|
3.13 billion cells/L
Interval 2.68 to 4.47
|
|
Levels of Neutrophils in Blood Samples - Step 1
Neutrophils, Dose 2, Day 60
|
3.96 billion cells/L
Interval 3.16 to 4.96
|
2.95 billion cells/L
Interval 2.5 to 3.71
|
|
Levels of Neutrophils in Blood Samples - Step 1
Neutrophils, Dose 1 (Day 0 H12)
|
7.61 billion cells/L
Interval 6.87 to 9.01
|
3.39 billion cells/L
Interval 3.0 to 4.53
|
|
Levels of Neutrophils in Blood Samples - Step 1
Neutrophils, Dose 1 (Day 0 H18)
|
6.07 billion cells/L
Interval 5.56 to 8.31
|
3.61 billion cells/L
Interval 3.31 to 4.12
|
SECONDARY outcome
Timeframe: At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Haematological laboratory parameters assessed included platelet count levels. Platelet count levels were expressed in billion cells per liter (billion cells/L). Platelet count levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=28 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=29 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Platelet Count in Blood Samples - Step 1
Platelets, Dose 1, Day 0
|
228 billion cells/L
Interval 191.5 to 261.5
|
225 billion cells/L
Interval 207.0 to 266.0
|
|
Platelet Count in Blood Samples - Step 1
Platelets, Dose 1 (Day 0 H6)
|
229 billion cells/L
Interval 204.0 to 259.5
|
231 billion cells/L
Interval 212.0 to 263.0
|
|
Platelet Count in Blood Samples - Step 1
Platelets, Dose 1 (Day 0 H12)
|
235 billion cells/L
Interval 193.0 to 259.0
|
230 billion cells/L
Interval 217.0 to 263.0
|
|
Platelet Count in Blood Samples - Step 1
Platelets, Dose 1 (Day 0 H18)
|
222 billion cells/L
Interval 186.0 to 260.0
|
233 billion cells/L
Interval 215.0 to 274.0
|
|
Platelet Count in Blood Samples - Step 1
Platelets, Dose 1, Day 1
|
220.5 billion cells/L
Interval 187.5 to 258.0
|
227 billion cells/L
Interval 206.0 to 269.0
|
|
Platelet Count in Blood Samples - Step 1
Platelets, Dose 1, Day 7
|
263.5 billion cells/L
Interval 215.5 to 291.0
|
247 billion cells/L
Interval 217.0 to 268.0
|
|
Platelet Count in Blood Samples - Step 1
Platelets, Dose 2, Day 30
|
224 billion cells/L
Interval 185.0 to 267.0
|
228 billion cells/L
Interval 204.0 to 260.0
|
|
Platelet Count in Blood Samples - Step 1
Platelets, Dose 2 (Day 30 H6)
|
238 billion cells/L
Interval 195.0 to 270.0
|
232 billion cells/L
Interval 212.0 to 261.5
|
|
Platelet Count in Blood Samples - Step 1
Platelets, Dose 2 (Day 30 H12)
|
226 billion cells/L
Interval 194.0 to 260.0
|
234 billion cells/L
Interval 213.5 to 258.0
|
|
Platelet Count in Blood Samples - Step 1
Platelets, Dose 2 (Day 30 H18)
|
230.5 billion cells/L
Interval 179.0 to 276.0
|
229 billion cells/L
Interval 199.0 to 275.0
|
|
Platelet Count in Blood Samples - Step 1
Platelets, Dose 2, Day 31
|
218 billion cells/L
Interval 170.0 to 238.0
|
217.5 billion cells/L
Interval 204.5 to 256.5
|
|
Platelet Count in Blood Samples - Step 1
Platelets, Dose 2, Day 37
|
253 billion cells/L
Interval 205.0 to 301.0
|
243 billion cells/L
Interval 208.5 to 282.0
|
|
Platelet Count in Blood Samples - Step 1
Platelets, Dose 2, Day 60
|
240 billion cells/L
Interval 195.0 to 283.0
|
241.5 billion cells/L
Interval 208.0 to 276.5
|
SECONDARY outcome
Timeframe: At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Haematological laboratory parameters assessed included red blood cells levels, expressed in trillion cells per liter (trillion cells/L). RBC levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=28 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=29 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Red Blood Cell (RBC) in Blood Samples - Step 1
RBC, Dose 1 (Day 0 H12)
|
4.42 trillion cells/L
Interval 4.12 to 4.68
|
4.51 trillion cells/L
Interval 4.27 to 4.78
|
|
Levels of Red Blood Cell (RBC) in Blood Samples - Step 1
RBC, Dose 1, Day 7
|
4.54 trillion cells/L
Interval 4.24 to 4.75
|
4.54 trillion cells/L
Interval 4.38 to 4.92
|
|
Levels of Red Blood Cell (RBC) in Blood Samples - Step 1
RBC, Dose 2, Day 37
|
4.5 trillion cells/L
Interval 4.13 to 4.84
|
4.52 trillion cells/L
Interval 4.2 to 4.88
|
|
Levels of Red Blood Cell (RBC) in Blood Samples - Step 1
RBC, Dose 2, Day 60
|
4.5 trillion cells/L
Interval 4.14 to 4.94
|
4.61 trillion cells/L
Interval 4.41 to 4.85
|
|
Levels of Red Blood Cell (RBC) in Blood Samples - Step 1
RBC, Dose 1, Day 0
|
4.51 trillion cells/L
Interval 4.33 to 4.83
|
4.56 trillion cells/L
Interval 4.27 to 4.96
|
|
Levels of Red Blood Cell (RBC) in Blood Samples - Step 1
RBC, Dose 1 (Day 0 H6)
|
4.45 trillion cells/L
Interval 4.18 to 4.82
|
4.58 trillion cells/L
Interval 4.24 to 4.78
|
|
Levels of Red Blood Cell (RBC) in Blood Samples - Step 1
RBC, Dose 1 (Day 0 H18)
|
4.19 trillion cells/L
Interval 4.02 to 4.79
|
4.36 trillion cells/L
Interval 4.19 to 4.72
|
|
Levels of Red Blood Cell (RBC) in Blood Samples - Step 1
RBC, Dose 1, Day 1
|
4.48 trillion cells/L
Interval 4.25 to 4.85
|
4.62 trillion cells/L
Interval 4.36 to 4.78
|
|
Levels of Red Blood Cell (RBC) in Blood Samples - Step 1
RBC, Dose 2, Day 30
|
4.48 trillion cells/L
Interval 4.27 to 4.7
|
4.53 trillion cells/L
Interval 4.25 to 4.79
|
|
Levels of Red Blood Cell (RBC) in Blood Samples - Step 1
RBC, Dose 2 (Day 30 H6)
|
4.43 trillion cells/L
Interval 4.14 to 4.6
|
4.49 trillion cells/L
Interval 4.26 to 4.8
|
|
Levels of Red Blood Cell (RBC) in Blood Samples - Step 1
RBC, Dose 2 (Day 30 H12)
|
4.33 trillion cells/L
Interval 4.21 to 4.62
|
4.46 trillion cells/L
Interval 4.25 to 4.71
|
|
Levels of Red Blood Cell (RBC) in Blood Samples - Step 1
RBC, Dose 2 (Day 30 H18)
|
4.22 trillion cells/L
Interval 3.86 to 4.66
|
4.34 trillion cells/L
Interval 4.09 to 4.62
|
|
Levels of Red Blood Cell (RBC) in Blood Samples - Step 1
RBC, Dose 2, Day 31
|
4.42 trillion cells/L
Interval 4.12 to 4.85
|
4.58 trillion cells/L
Interval 4.38 to 4.9
|
SECONDARY outcome
Timeframe: At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Biochemical laboratory parameters assessed included urea levels, expressed in miligrams per deciliter (mg/dL). Urea levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=28 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=29 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Urea in Blood Samples - Step 1
Urea Nitrogen, Dose 1, Day 0
|
27.5 mg/dL
Interval 23.0 to 35.5
|
30 mg/dL
Interval 26.0 to 35.0
|
|
Levels of Urea in Blood Samples - Step 1
Urea Nitrogen, Dose 1, Day 1
|
23.5 mg/dL
Interval 18.5 to 29.0
|
25 mg/dL
Interval 23.0 to 30.0
|
|
Levels of Urea in Blood Samples - Step 1
Urea Nitrogen, Dose 1, Day 7
|
27.5 mg/dL
Interval 24.5 to 35.0
|
27 mg/dL
Interval 23.0 to 31.0
|
|
Levels of Urea in Blood Samples - Step 1
Urea Nitrogen, Dose 2, Day 30
|
28 mg/dL
Interval 25.0 to 37.0
|
26 mg/dL
Interval 22.0 to 33.0
|
|
Levels of Urea in Blood Samples - Step 1
Urea Nitrogen, Dose 2 (Day 30 H6)
|
29 mg/dL
Interval 24.0 to 34.0
|
26 mg/dL
Interval 23.0 to 32.5
|
|
Levels of Urea in Blood Samples - Step 1
Urea Nitrogen, Dose 1 (Day 0 H6)
|
27 mg/dL
Interval 24.0 to 31.5
|
30 mg/dL
Interval 26.0 to 34.0
|
|
Levels of Urea in Blood Samples - Step 1
Urea Nitrogen, Dose 1 (Day 0 H12)
|
27 mg/dL
Interval 24.0 to 31.5
|
29 mg/dL
Interval 27.0 to 32.0
|
|
Levels of Urea in Blood Samples - Step 1
Urea Nitrogen, Dose 1 (Day 0 H18)
|
23 mg/dL
Interval 21.0 to 32.0
|
27 mg/dL
Interval 24.0 to 30.0
|
|
Levels of Urea in Blood Samples - Step 1
Urea Nitrogen, Dose 2 (Day 30 H12)
|
28 mg/dL
Interval 24.0 to 34.0
|
27 mg/dL
Interval 23.5 to 32.0
|
|
Levels of Urea in Blood Samples - Step 1
Urea Nitrogen, Dose 2 (Day 30 H18)
|
25.5 mg/dL
Interval 21.0 to 31.0
|
24.5 mg/dL
Interval 22.0 to 28.0
|
|
Levels of Urea in Blood Samples - Step 1
Urea Nitrogen, Dose 2, Day 31
|
23 mg/dL
Interval 19.0 to 30.0
|
26 mg/dL
Interval 21.0 to 28.5
|
|
Levels of Urea in Blood Samples - Step 1
Urea Nitrogen, Dose 2, Day 37
|
26 mg/dL
Interval 22.0 to 36.0
|
25.5 mg/dL
Interval 23.0 to 31.0
|
|
Levels of Urea in Blood Samples - Step 1
Urea Nitrogen, Dose 2, Day 60
|
29 mg/dL
Interval 22.0 to 33.0
|
27 mg/dL
Interval 23.5 to 30.0
|
SECONDARY outcome
Timeframe: At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Haematological laboratory parameters assessed included WBC levels. WBC levels were expressed in billion cells per liter (billion cells/L). WBC levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=28 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=29 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of White Blood Cells (WBC) - Step 1
WBC, Dose 1 (Day 0 H18)
|
8.72 billion cells/L
Interval 7.63 to 12.2
|
7.43 billion cells/L
Interval 7.15 to 8.02
|
|
Levels of White Blood Cells (WBC) - Step 1
WBC, Dose 1, Day 1
|
8.7 billion cells/L
Interval 6.37 to 9.7
|
6.25 billion cells/L
Interval 5.85 to 6.83
|
|
Levels of White Blood Cells (WBC) - Step 1
WBC, Dose 1, Day 0
|
6.25 billion cells/L
Interval 5.53 to 8.49
|
6.33 billion cells/L
Interval 5.46 to 7.03
|
|
Levels of White Blood Cells (WBC) - Step 1
WBC, Dose 1 (Day 0 H6)
|
9.73 billion cells/L
Interval 7.7 to 11.3
|
6.49 billion cells/L
Interval 5.78 to 7.37
|
|
Levels of White Blood Cells (WBC) - Step 1
WBC, Dose 1 (Day 0 H12)
|
10.45 billion cells/L
Interval 9.75 to 12.4
|
6.84 billion cells/L
Interval 6.0 to 7.4
|
|
Levels of White Blood Cells (WBC) - Step 1
WBC, Dose 1, Day 7
|
6.67 billion cells/L
Interval 5.49 to 8.17
|
6.14 billion cells/L
Interval 5.27 to 7.32
|
|
Levels of White Blood Cells (WBC) - Step 1
WBC, Dose 2, Day 30
|
6.04 billion cells/L
Interval 5.48 to 8.07
|
5.77 billion cells/L
Interval 4.96 to 7.21
|
|
Levels of White Blood Cells (WBC) - Step 1
WBC, Dose 2 (Day 30 H6)
|
9.28 billion cells/L
Interval 7.91 to 10.4
|
6.07 billion cells/L
Interval 5.76 to 6.96
|
|
Levels of White Blood Cells (WBC) - Step 1
WBC, Dose 2 (Day 30 H12)
|
9.88 billion cells/L
Interval 9.29 to 11.4
|
6.28 billion cells/L
Interval 5.8 to 7.37
|
|
Levels of White Blood Cells (WBC) - Step 1
WBC, Dose 2 (Day 30 H18)
|
9.57 billion cells/L
Interval 8.24 to 12.2
|
6.8 billion cells/L
Interval 6.49 to 7.21
|
|
Levels of White Blood Cells (WBC) - Step 1
WBC, Dose 2, Day 31
|
8.21 billion cells/L
Interval 6.78 to 9.36
|
6.34 billion cells/L
Interval 5.67 to 7.16
|
|
Levels of White Blood Cells (WBC) - Step 1
WBC, Dose 2, Day 37
|
5.7 billion cells/L
Interval 5.13 to 8.46
|
6.25 billion cells/L
Interval 5.46 to 7.31
|
|
Levels of White Blood Cells (WBC) - Step 1
WBC, Dose 2, Day 60
|
6.48 billion cells/L
Interval 5.45 to 8.24
|
6.07 billion cells/L
Interval 5.04 to 6.7
|
SECONDARY outcome
Timeframe: At Day -30, -30 (H1.5, H3, H6, H9, H12, H18) -29, - 28, - 27, -23, 0, 0 (H1.5, H6, H12 H18), 1, 2, 7, 30, 30 (H1.5, H3, H6, H9, H12, H18), 31, 32, 33, 37 and 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Diastolic pressure was part of the list of vital signs followed at specific protocol-defined time points during this study, measured in millimeter of mercury (mmHg). On Days -30, 0 and 30, diastolic blood pressure was assessed at multiple time points (plus 1.5, 3, 6, 9, 12 and 18 hours - H1.5, H3, H6, H9, H12 and H18).
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, placebo (D-30)
|
81 mmHg
Interval 74.0 to 86.0
|
76.5 mmHg
Interval 67.0 to 83.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, placebo (D-30 H9)
|
76 mmHg
Interval 71.0 to 86.0
|
75 mmHg
Interval 67.0 to 84.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, placebo (D-30 H12)
|
78 mmHg
Interval 69.0 to 84.0
|
72.5 mmHg
Interval 66.0 to 80.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, Dose 2 (D30 H1.5)
|
72 mmHg
Interval 67.0 to 78.0
|
70 mmHg
Interval 66.0 to 76.5
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, Dose 2 (D30 H12)
|
73 mmHg
Interval 68.0 to 78.0
|
72.5 mmHg
Interval 66.5 to 79.5
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, placebo (D-30 H1.5)
|
75 mmHg
Interval 69.0 to 83.0
|
72 mmHg
Interval 65.0 to 79.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, placebo (D-30 H3)
|
75.5 mmHg
Interval 68.0 to 83.0
|
71.5 mmHg
Interval 65.0 to 80.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, placebo (D-30 H6)
|
73.5 mmHg
Interval 67.0 to 83.0
|
71.5 mmHg
Interval 67.0 to 82.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, placebo (D-30 H18)
|
75 mmHg
Interval 67.0 to 80.0
|
68 mmHg
Interval 64.0 to 84.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, placebo (D-29)
|
77 mmHg
Interval 70.0 to 83.0
|
73.5 mmHg
Interval 64.0 to 81.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, placebo (D-28)
|
75 mmHg
Interval 70.0 to 83.0
|
74.5 mmHg
Interval 69.0 to 78.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, placebo (D-27)
|
78 mmHg
Interval 72.0 to 82.0
|
75 mmHg
Interval 71.0 to 81.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, placebo (D-23)
|
76 mmHg
Interval 71.0 to 81.0
|
75.5 mmHg
Interval 66.0 to 80.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, Dose 1 (D0)
|
76 mmHg
Interval 70.5 to 83.0
|
76 mmHg
Interval 68.0 to 85.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, Dose 1 (D0 H1.5)
|
74 mmHg
Interval 70.0 to 81.0
|
73 mmHg
Interval 67.0 to 78.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, Dose 1 (D0 H6)
|
73.5 mmHg
Interval 67.5 to 80.0
|
72 mmHg
Interval 65.0 to 78.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, Dose 1 (D0 H12)
|
72 mmHg
Interval 69.0 to 79.5
|
72 mmHg
Interval 66.0 to 79.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, Dose 1 (D0 H18)
|
73 mmHg
Interval 61.0 to 78.0
|
66.5 mmHg
Interval 60.0 to 78.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, Dose 1 (D1)
|
72 mmHg
Interval 69.0 to 79.0
|
76 mmHg
Interval 66.0 to 80.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, Dose 1 (D2)
|
74 mmHg
Interval 70.0 to 81.5
|
73 mmHg
Interval 67.0 to 79.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, Dose 1 (D7)
|
75 mmHg
Interval 71.0 to 79.5
|
73 mmHg
Interval 70.0 to 82.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, Dose 2 (D30)
|
76 mmHg
Interval 69.0 to 80.0
|
77.5 mmHg
Interval 68.5 to 83.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, Dose 2 (D30 H3)
|
72 mmHg
Interval 68.0 to 79.0
|
72 mmHg
Interval 63.0 to 78.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, Dose 2 (D30 H6)
|
72 mmHg
Interval 69.0 to 75.0
|
70.5 mmHg
Interval 65.5 to 75.5
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, Dose 2 (D30 H9)
|
75 mmHg
Interval 71.0 to 79.0
|
75 mmHg
Interval 65.5 to 81.5
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, Dose 2 (D30 H18)
|
70 mmHg
Interval 64.0 to 74.0
|
71.5 mmHg
Interval 66.0 to 79.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, Dose 2 (D31)
|
71 mmHg
Interval 67.0 to 77.0
|
71 mmHg
Interval 65.5 to 80.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, Dose 2 (D32)
|
77 mmHg
Interval 71.0 to 81.0
|
74 mmHg
Interval 67.0 to 79.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, Dose 2 (D33)
|
77 mmHg
Interval 71.0 to 81.0
|
73 mmHg
Interval 70.5 to 79.5
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, Dose 2 (D37)
|
76 mmHg
Interval 68.0 to 86.0
|
74 mmHg
Interval 68.5 to 79.5
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, Dose 2 (D60)
|
78 mmHg
Interval 72.0 to 84.0
|
73 mmHg
Interval 67.0 to 81.5
|
SECONDARY outcome
Timeframe: At Day -30, -30 (H1.5, H3, H6, H9, H12, H18) -29, - 28, - 27, -23, 0, 0 (H1.5, H6, H12 H18), 1, 2, 7, 30, 30 (H1.5, H3, H6, H9, H12, H18), 31, 32, 33, 37 and 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Heart rate was part of the list of vital signs followed at specific protocol-defined timepoints during this study. It was expressed in beats per minute. On Days -30, 0 and 30, heart rate was assessed at multiple time points (plus 1.5, 3, 6, 9, 12 and 18 hours - H1.5, H3, H6, H9, H12 and H18).
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Heart Rate - Step 1
Heart rate, placebo (D-30 H3)
|
69.5 beats/minute
Interval 56.0 to 76.0
|
63.5 beats/minute
Interval 58.0 to 71.0
|
|
Levels of Heart Rate - Step 1
Heart rate, placebo (D-30 H6)
|
69 beats/minute
Interval 61.0 to 78.0
|
69 beats/minute
Interval 60.0 to 80.0
|
|
Levels of Heart Rate - Step 1
Heart rate, placebo (D-30 H9)
|
66.5 beats/minute
Interval 56.0 to 82.0
|
65 beats/minute
Interval 55.0 to 70.0
|
|
Levels of Heart Rate - Step 1
Heart rate, placebo (D-29)
|
74.5 beats/minute
Interval 63.0 to 82.0
|
65.5 beats/minute
Interval 62.0 to 70.0
|
|
Levels of Heart Rate - Step 1
Heart rate, placebo (D-28)
|
70 beats/minute
Interval 66.0 to 82.0
|
73.5 beats/minute
Interval 65.0 to 81.0
|
|
Levels of Heart Rate - Step 1
Heart rate, placebo (D-27)
|
72 beats/minute
Interval 66.0 to 80.0
|
70 beats/minute
Interval 65.0 to 81.0
|
|
Levels of Heart Rate - Step 1
Heart rate, Dose 1 (D0)
|
69.5 beats/minute
Interval 62.0 to 80.5
|
72 beats/minute
Interval 62.0 to 79.0
|
|
Levels of Heart Rate - Step 1
Heart rate, Dose 1 (D0 H1.5)
|
67.5 beats/minute
Interval 62.0 to 76.0
|
68 beats/minute
Interval 62.0 to 77.0
|
|
Levels of Heart Rate - Step 1
Heart rate, Dose 2 (D30 H1.5)
|
69 beats/minute
Interval 60.0 to 78.0
|
68.5 beats/minute
Interval 57.5 to 79.0
|
|
Levels of Heart Rate - Step 1
Heart rate, Dose 2 (D30 H3)
|
66 beats/minute
Interval 55.0 to 74.0
|
65 beats/minute
Interval 60.5 to 76.0
|
|
Levels of Heart Rate - Step 1
Heart rate, Dose 2 (D30 H6)
|
73 beats/minute
Interval 64.0 to 80.0
|
71.5 beats/minute
Interval 62.5 to 81.0
|
|
Levels of Heart Rate - Step 1
Heart rate, Dose 2 (D30 H12)
|
79 beats/minute
Interval 66.0 to 85.0
|
69.5 beats/minute
Interval 63.0 to 81.0
|
|
Levels of Heart Rate - Step 1
Heart rate, Dose 2 (D30 H18)
|
84.5 beats/minute
Interval 79.0 to 90.0
|
74.5 beats/minute
Interval 66.0 to 80.0
|
|
Levels of Heart Rate - Step 1
Heart rate, Dose 2 (D31)
|
81 beats/minute
Interval 65.0 to 89.0
|
66.5 beats/minute
Interval 58.0 to 77.5
|
|
Levels of Heart Rate - Step 1
Heart rate, Dose 2 (D32)
|
70 beats/minute
Interval 63.0 to 83.0
|
70.5 beats/minute
Interval 62.0 to 77.5
|
|
Levels of Heart Rate - Step 1
Heart rate, Dose 1 (D0 H6)
|
66 beats/minute
Interval 60.5 to 80.5
|
68 beats/minute
Interval 65.0 to 79.0
|
|
Levels of Heart Rate - Step 1
Heart rate, Dose 1 (D0 H12)
|
76 beats/minute
Interval 66.5 to 83.0
|
69 beats/minute
Interval 61.0 to 79.0
|
|
Levels of Heart Rate - Step 1
Heart rate, Dose 1 (D0 H18)
|
76 beats/minute
Interval 60.0 to 83.0
|
67 beats/minute
Interval 60.0 to 77.0
|
|
Levels of Heart Rate - Step 1
Heart rate, Dose 1 (D1)
|
72 beats/minute
Interval 65.0 to 82.0
|
67 beats/minute
Interval 64.0 to 75.0
|
|
Levels of Heart Rate - Step 1
Heart rate, Dose 1 (D2)
|
71.5 beats/minute
Interval 60.0 to 80.0
|
69 beats/minute
Interval 65.0 to 79.0
|
|
Levels of Heart Rate - Step 1
Heart rate, Dose 1 (D7)
|
74 beats/minute
Interval 63.0 to 80.5
|
71 beats/minute
Interval 62.0 to 82.0
|
|
Levels of Heart Rate - Step 1
Heart rate, Dose 2 (D30)
|
65 beats/minute
Interval 59.0 to 77.0
|
66.5 beats/minute
Interval 58.0 to 76.5
|
|
Levels of Heart Rate - Step 1
Heart rate, Dose 2 (D30 H9)
|
72 beats/minute
Interval 57.0 to 81.0
|
65.5 beats/minute
Interval 59.0 to 79.0
|
|
Levels of Heart Rate - Step 1
Heart rate, Dose 2 (D33)
|
69 beats/minute
Interval 63.0 to 81.0
|
70.5 beats/minute
Interval 64.5 to 79.0
|
|
Levels of Heart Rate - Step 1
Heart rate, Dose 2 (D37)
|
67 beats/minute
Interval 59.0 to 79.0
|
72.5 beats/minute
Interval 61.5 to 79.5
|
|
Levels of Heart Rate - Step 1
Heart rate, Dose 2 (D60)
|
72 beats/minute
Interval 67.0 to 80.0
|
71 beats/minute
Interval 63.5 to 79.5
|
|
Levels of Heart Rate - Step 1
Heart rate, placebo (D-30)
|
75.5 beats/minute
Interval 62.0 to 86.0
|
70 beats/minute
Interval 64.0 to 79.0
|
|
Levels of Heart Rate - Step 1
Heart rate, placebo (D-30 H1.5)
|
75 beats/minute
Interval 62.0 to 82.0
|
73 beats/minute
Interval 62.0 to 77.0
|
|
Levels of Heart Rate - Step 1
Heart rate, placebo (D-30 H12)
|
71.5 beats/minute
Interval 64.0 to 80.0
|
72.5 beats/minute
Interval 60.0 to 81.0
|
|
Levels of Heart Rate - Step 1
Heart rate, placebo (D-30 H18)
|
66 beats/minute
Interval 55.0 to 75.0
|
70 beats/minute
Interval 66.0 to 77.0
|
|
Levels of Heart Rate - Step 1
Heart rate, placebo (D-23)
|
72 beats/minute
Interval 66.0 to 80.0
|
66 beats/minute
Interval 58.0 to 75.0
|
SECONDARY outcome
Timeframe: At Day -30, -30 (H1.5, H3, H6, H9, H12, H18) -29, - 28, - 27, -23, 0, 0 (H1.5, H6, H12 H18), 1, 2, 7, 30, 30 (H1.5, H3, H6, H9, H12, H18), 31, 32, 33, 37 and 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Respiratory Rate was part of the list of vital signs followed at specific protocol-defined timepoints during this study. It was expressed as breaths per minute (breaths/min). On Days -30, 0 and 30, respiratory rate was assessed at multiple time points (plus 1.5, 3, 6, 9, 12 and 18 hours - H1.5, H3, H6, H9, H12 and H18).
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, placebo (D-30 H6)
|
12.5 breaths/min
Interval 12.0 to 16.0
|
14 breaths/min
Interval 13.0 to 16.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, placebo (D-30 H18)
|
13 breaths/min
Interval 12.0 to 14.0
|
12 breaths/min
Interval 11.0 to 14.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, placebo (D-28)
|
14 breaths/min
Interval 12.0 to 16.0
|
14 breaths/min
Interval 13.0 to 16.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, placebo (D-27)
|
14 breaths/min
Interval 12.0 to 14.0
|
14 breaths/min
Interval 13.0 to 14.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, placebo (D-23)
|
14 breaths/min
Interval 12.0 to 15.0
|
14 breaths/min
Interval 13.0 to 15.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, Dose 1 (D0 H1.5)
|
14 breaths/min
Interval 12.0 to 15.0
|
14 breaths/min
Interval 13.0 to 15.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, Dose 1 (D1)
|
14 breaths/min
Interval 12.0 to 15.0
|
14 breaths/min
Interval 13.0 to 14.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, Dose 1 (D2)
|
14 breaths/min
Interval 13.0 to 14.5
|
14 breaths/min
Interval 12.0 to 15.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, Dose 2 (D30 H1.5)
|
14 breaths/min
Interval 13.0 to 15.0
|
14 breaths/min
Interval 13.0 to 15.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, Dose 2 (D33)
|
13 breaths/min
Interval 12.0 to 14.0
|
14 breaths/min
Interval 13.0 to 15.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, Dose 2 (D37)
|
14 breaths/min
Interval 12.0 to 16.0
|
14 breaths/min
Interval 12.5 to 15.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, placebo (D-30)
|
14 breaths/min
Interval 12.0 to 16.0
|
13 breaths/min
Interval 12.0 to 16.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, placebo (D-30 H1.5)
|
13 breaths/min
Interval 12.0 to 15.0
|
14.5 breaths/min
Interval 13.0 to 16.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, placebo (D-30 H3)
|
13 breaths/min
Interval 12.0 to 15.0
|
14 breaths/min
Interval 12.0 to 15.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, placebo (D-30 H9)
|
13 breaths/min
Interval 12.0 to 15.0
|
15 breaths/min
Interval 13.0 to 16.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, placebo (D-30 H12)
|
14 breaths/min
Interval 12.0 to 15.0
|
14.5 breaths/min
Interval 13.0 to 15.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, placebo (D-29)
|
13.5 breaths/min
Interval 12.0 to 16.0
|
14 breaths/min
Interval 13.0 to 15.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, Dose 1 (D0)
|
14 breaths/min
Interval 12.5 to 15.5
|
14 breaths/min
Interval 12.0 to 15.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, Dose 1 (D0 H6)
|
14 breaths/min
Interval 13.0 to 15.0
|
14 breaths/min
Interval 13.0 to 15.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, Dose 1 (D0 H12)
|
13.5 breaths/min
Interval 12.0 to 14.0
|
14 breaths/min
Interval 13.0 to 14.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, Dose 1 (D0 H18)
|
13 breaths/min
Interval 12.0 to 15.0
|
14 breaths/min
Interval 13.0 to 15.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, Dose 1 (D7)
|
13.5 breaths/min
Interval 13.0 to 14.5
|
13 breaths/min
Interval 13.0 to 14.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, Dose 2 (D30)
|
14 breaths/min
Interval 12.0 to 15.0
|
14 breaths/min
Interval 12.0 to 16.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, Dose 2 (D30 H3)
|
14 breaths/min
Interval 12.0 to 15.0
|
14 breaths/min
Interval 12.0 to 15.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, Dose 2 (D30 H6)
|
13 breaths/min
Interval 12.0 to 15.0
|
14 breaths/min
Interval 12.0 to 15.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, Dose 2 (D30 H9)
|
14 breaths/min
Interval 12.0 to 15.0
|
13.5 breaths/min
Interval 12.5 to 14.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, Dose 2 (D30 H12)
|
14 breaths/min
Interval 12.0 to 15.0
|
14 breaths/min
Interval 13.0 to 15.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, Dose 2 (D30 H18)
|
14 breaths/min
Interval 12.0 to 15.0
|
14 breaths/min
Interval 14.0 to 15.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, Dose 2 (D31)
|
13 breaths/min
Interval 12.0 to 15.0
|
14 breaths/min
Interval 12.0 to 15.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, Dose 2 (D32)
|
14 breaths/min
Interval 12.0 to 14.0
|
14 breaths/min
Interval 13.0 to 15.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, Dose 2 (D60)
|
14 breaths/min
Interval 12.0 to 15.0
|
14 breaths/min
Interval 13.0 to 16.0
|
SECONDARY outcome
Timeframe: At Day -30, -30 (H1.5, H3, H6, H9, H12, H18) -29, - 28, - 27, -23, 0, 0 (H1.5, H6, H12 H18), 1, 2, 7, 30, 30 (H1.5, H3, H6, H9, H12, H18), 31, 32, 33, 37 and 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Systolic pressure was part of the list of vital signs followed at specific protocol-defined time points during this study, measured in millimeter of mercury (mmHg). On Days -30, 0 and 30, systolic pressure was assessed at multiple time points (plus 1.5, 3, 6, 9, 12 and 18 hours - H1.5, H3, H6, H9, H12 and H18).
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Systolic Pressure - Step 1
Systolic, placebo (D-30 H1.5)
|
117 mmHg
Interval 111.0 to 124.0
|
114 mmHg
Interval 103.0 to 124.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, placebo (D-30 H3)
|
117.5 mmHg
Interval 112.0 to 126.0
|
114 mmHg
Interval 105.0 to 118.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, placebo (D-29)
|
116.5 mmHg
Interval 111.0 to 124.0
|
112 mmHg
Interval 104.0 to 122.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, placebo (D-28)
|
121 mmHg
Interval 110.0 to 124.0
|
114 mmHg
Interval 103.0 to 121.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, Dose 1 (D0 H18)
|
112 mmHg
Interval 104.0 to 121.0
|
105 mmHg
Interval 99.0 to 122.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, Dose 1 (D1)
|
114 mmHg
Interval 108.5 to 119.0
|
114 mmHg
Interval 104.0 to 123.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, Dose 1 (D2)
|
115 mmHg
Interval 110.0 to 124.0
|
111 mmHg
Interval 103.0 to 118.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, Dose 1 (D7)
|
116 mmHg
Interval 111.0 to 120.5
|
113 mmHg
Interval 107.0 to 123.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, Dose 2 (D30)
|
115 mmHg
Interval 112.0 to 121.0
|
112.5 mmHg
Interval 106.5 to 122.5
|
|
Levels of Systolic Pressure - Step 1
Systolic, Dose 2 (D33)
|
116 mmHg
Interval 112.0 to 122.0
|
111.5 mmHg
Interval 106.0 to 119.5
|
|
Levels of Systolic Pressure - Step 1
Systolic, placebo (D-30)
|
123.5 mmHg
Interval 112.0 to 130.0
|
116 mmHg
Interval 106.0 to 125.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, placebo (D-30 H6)
|
118 mmHg
Interval 113.0 to 124.0
|
112 mmHg
Interval 105.0 to 124.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, placebo (D-30 H9)
|
120.5 mmHg
Interval 112.0 to 131.0
|
114.5 mmHg
Interval 106.0 to 123.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, placebo (D-30 H12)
|
121.5 mmHg
Interval 112.0 to 129.0
|
112 mmHg
Interval 105.0 to 125.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, placebo (D-30 H18)
|
111 mmHg
Interval 106.0 to 122.0
|
106 mmHg
Interval 96.0 to 118.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, placebo (D-27)
|
119 mmHg
Interval 112.0 to 124.0
|
115.5 mmHg
Interval 109.0 to 121.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, placebo (D-23)
|
118 mmHg
Interval 110.0 to 123.0
|
115 mmHg
Interval 104.0 to 122.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, Dose 1 (D0)
|
118 mmHg
Interval 112.0 to 122.5
|
114 mmHg
Interval 108.0 to 124.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, Dose 1 (D0 H1.5)
|
116 mmHg
Interval 110.5 to 121.5
|
109 mmHg
Interval 102.0 to 119.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, Dose 1 (D0 H6)
|
117 mmHg
Interval 111.0 to 121.5
|
112 mmHg
Interval 103.0 to 117.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, Dose 1 (D0 H12)
|
115 mmHg
Interval 110.0 to 126.0
|
114 mmHg
Interval 107.0 to 120.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, Dose 2 (D30 H1.5)
|
115 mmHg
Interval 108.0 to 124.0
|
109.5 mmHg
Interval 102.0 to 117.5
|
|
Levels of Systolic Pressure - Step 1
Systolic, Dose 2 (D30 H3)
|
116 mmHg
Interval 111.0 to 124.0
|
113 mmHg
Interval 103.0 to 120.5
|
|
Levels of Systolic Pressure - Step 1
Systolic, Dose 2 (D30 H6)
|
117 mmHg
Interval 107.0 to 122.0
|
112 mmHg
Interval 103.5 to 118.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, Dose 2 (D30 H9)
|
117 mmHg
Interval 108.0 to 121.0
|
116 mmHg
Interval 108.5 to 124.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, Dose 2 (D30 H12)
|
116 mmHg
Interval 109.0 to 125.0
|
116.5 mmHg
Interval 105.0 to 122.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, Dose 2 (D30 H18)
|
109.5 mmHg
Interval 102.0 to 115.0
|
107 mmHg
Interval 100.0 to 122.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, Dose 2 (D31)
|
114 mmHg
Interval 108.0 to 123.0
|
109.5 mmHg
Interval 104.0 to 119.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, Dose 2 (D32)
|
116 mmHg
Interval 113.0 to 120.0
|
110.5 mmHg
Interval 103.0 to 115.5
|
|
Levels of Systolic Pressure - Step 1
Systolic, Dose 2 (D37)
|
120 mmHg
Interval 108.0 to 126.0
|
112 mmHg
Interval 106.0 to 124.5
|
|
Levels of Systolic Pressure - Step 1
Systolic, Dose 2 (D60)
|
120 mmHg
Interval 109.0 to 125.0
|
115 mmHg
Interval 106.5 to 122.5
|
SECONDARY outcome
Timeframe: At Day 0 (PRE) and post-vaccination (Day 44 for HBsAg/AS_2 Group and Day 194 for Engerix-B_2 Group)Population: Analyses were performed on the According-To-Protocol (ATP) cohort for adaptive immunogenicity up to 30 days (step 2 only) post last vaccination, which included all evaluable subjects, who complied with the protocol and for whom data concerning adaptive immunogenicity were available for at least one adaptive assay at one post-vaccination time point.
Anti-HBs antibody concentrations in serum were measured by CLIA Assay. Concentrations were presented as geometric mean concentrations, in milli-International Units per milliliter (mIU/mL).
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=8 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 2 Immuno
Anti-HBs, PRE
|
3.1 mIU/mL
Interval 3.1 to 3.1
|
3.1 mIU/mL
Interval 3.1 to 3.1
|
|
Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 2 Immuno
Anti-HBs, D44
|
8447.1 mIU/mL
Interval 4040.7 to 17658.9
|
—
|
|
Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 2 Immuno
Anti-HBs, D194
|
—
|
1996.3 mIU/mL
Interval 143.8 to 27707.6
|
SECONDARY outcome
Timeframe: At Day 0 (PRE) and post-vaccination (Day 44 for HBsAg/AS_2 Group and Day 194 for Engerix-B_2 Group)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence (step 2 only) included all evaluable subjects, who complied with the protocol, for whom data concerning adaptive immunogenicity were available for at least one adaptive assay at Day 180 for the HBsAg/AS\_2 Group and at Day 330 for the Engerix-B\_2 Group.
Anti-HBs antibody concentrations in serum were measured by CLIA Assay. Concentrations were presented as geometric mean concentrations, in milli-International Units per milliliter (mIU/mL).
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 2 Persistence
Anti-HBs, PRE
|
3.1 mIU/mL
Interval 3.1 to 3.1
|
3.1 mIU/mL
Interval 3.1 to 3.1
|
|
Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 2 Persistence
Anti-HBs, D44
|
8447.1 mIU/mL
Interval 4040.7 to 17658.9
|
—
|
|
Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 2 Persistence
Anti-HBs, D194
|
—
|
2454.9 mIU/mL
Interval 311.4 to 19354.5
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each vaccine dose and across dosesPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Any Redness, Dose 1
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Grade 3 Pain, Dose 2
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Grade 3 Swelling, Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Grade 3 Swelling, Across doses
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Grade 3 Redness, Across doses
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Any Swelling, Across doses
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Any Pain, Dose 1
|
10 Participants
|
3 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Grade 3 Pain, Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Grade 3 Redness, Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Any Swelling, Dose 1
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Grade 3 Swelling, Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Any Pain, Dose 2
|
10 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Any Redness, Dose 2
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Grade 3 Redness, Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Any Swelling, Dose 2
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Any Pain, Dose 3
|
—
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Grade 3 Pain, Dose 3
|
—
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Any Redness, Dose 3
|
—
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Grade 3 Redness, Dose 3
|
—
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Any Swelling, Dose 3
|
—
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Grade 3 Swelling, Dose 3
|
—
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Any Pain, Across doses
|
10 Participants
|
4 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Grade 3 Pain, Across doses
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Any Redness, Across doses
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each vaccine dose and across dosesPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=38 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=39 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Any Pain, Dose 1
|
28 Participants
|
10 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Grade 3 Pain, Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Any Redness, Dose 1
|
9 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Grade 3 Redness, Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Any Swelling, Dose 1
|
6 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Grade 3 Swelling, Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Any Pain, Dose 2
|
25 Participants
|
7 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Grade 3 Pain, Dose 2
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Any Redness, Dose 2
|
7 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Grade 3 Redness, Dose 2
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Any Swelling, Dose 2
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Grade 3 Swelling, Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Any Pain, Dose 3
|
—
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Grade 3 Pain, Dose 3
|
—
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Any Redness, Dose 3
|
—
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Grade 3 Redness, Dose 3
|
—
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Any Swelling, Dose 3
|
—
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Grade 3 Swelling, Dose 3
|
—
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Any Pain, Across doses
|
31 Participants
|
12 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Grade 3 Pain, Across doses
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Any Redness, Across doses
|
12 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Grade 3 Redness, Across doses
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Any Swelling, Across doses
|
7 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Grade 3 Swelling, Across doses
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each vaccine dose and across dosesPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms \[nausea, vomiting, diarrhoea and/or abdominal pain\], headache, malaise, myalgia, shivering and temperature \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. At Day 0 of dose 2, two temperatures were collected: one at Hour 0 (H0) and a second one at Hour 18 (H18). The highest temperature between H0 et H18 was taken.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Fatigue, Dose 1
|
8 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Fatigue, Dose 1
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Fatigue, Dose 1
|
7 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Gastrointestinal Symptoms, Dose 1
|
5 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Gastrointestinal Symptoms, Dose 1
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Gastrointestinal Symptoms, Dose 1
|
5 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Headache, Dose 1
|
7 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Shivering, Dose 1
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Headache, Dose 1
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Myalgia, Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Myalgia, Dose 1
|
7 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Shivering, Dose 1
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Malaise, Dose 2
|
7 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Myalgia, Dose 2
|
9 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Temperature, Dose 1
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Temperature, Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Temperature, Dose 1
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Fatigue, Dose 2
|
7 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Fatigue, Dose 2
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Fatigue, Dose 2
|
7 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Gastrointestinal Symptoms, Dose 2
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Gastrointestinal Symptoms, Dose 2
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Gastrointestinal Symptoms, Dose 2
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Headache, Dose 2
|
6 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Headache, Dose 2
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Headache, Dose 2
|
6 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Malaise, Dose 2
|
7 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Malaise, Dose 2
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Myalgia, Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Myalgia, Dose 2
|
9 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Shivering, Dose 2
|
5 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Shivering, Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Shivering, Dose 2
|
5 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Temperature, Dose 2
|
4 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Temperature, Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Temperature, Dose 2
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Fatigue, Dose 3
|
—
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Fatigue, Dose 3
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Fatigue, Dose 3
|
—
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Gastrointestinal Symptoms, Dose 3
|
—
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Gastrointestinal Symptoms, Dose 3
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Gastrointestinal Symptoms, Dose 3
|
—
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Headache, Dose 3
|
—
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Headache, Dose 3
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Headache, Dose 3
|
—
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Malaise, Dose 3
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Malaise, Dose 3
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Malaise, Dose 3
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Myalgia, Dose 3
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Myalgia, Dose 3
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Myalgia, Dose 3
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Shivering, Dose 3
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Shivering, Dose 3
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Shivering, Dose 3
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Temperature, Dose 3
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Temperature, Dose 3
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Temperature, Dose 3
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Fatigue, Across doses
|
8 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Fatigue, Across doses
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Fatigue, Across doses
|
8 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Gastrointestinal Symptoms, Across doses
|
6 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Gastrointestinal Symptoms, Across doses
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Gastrointestinal Symptoms, Across doses
|
6 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Headache, Across doses
|
9 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Headache, Across doses
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Headache, Across doses
|
9 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Malaise, Across doses
|
7 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Malaise, Across doses
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Malaise, Across doses
|
7 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Myalgia, Across doses
|
9 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Myalgia, Across doses
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Myalgia, Across doses
|
9 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Shivering, Across doses
|
6 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Shivering, Across doses
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Shivering, Across doses
|
6 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Temperature, Across doses
|
6 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Temperature, Across doses
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Temperature, Across doses
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Headache, Dose 1
|
7 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Malaise, Dose 1
|
5 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Malaise, Dose 1
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Malaise, Dose 1
|
5 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Myalgia, Dose 1
|
7 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Shivering, Dose 1
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each vaccine dose and across dosesPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms \[nausea, vomiting, diarrhoea and/or abdominal pain\], headache, malaise, myalgia, shivering and temperature \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. There was no pooling for temperature symptom between Step 1 and Step 2 due to difference in recording approach for the 18 hour data (nurse or self-assessment).
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=38 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=39 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Fatigue, Dose 1
|
11 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Fatigue, Dose 1
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Fatigue, Dose 1
|
9 Participants
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Gastrointestinal Symptoms, Dose 1
|
9 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Gastrointestinal Symptoms, Dose 1
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Gastrointestinal Symptoms, Dose 1
|
9 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Headache, Dose 1
|
21 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Headache, Dose 1
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Headache, Dose 1
|
18 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Malaise, Dose 1
|
9 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Malaise, Dose 1
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Malaise, Dose 1
|
9 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Myalgia, Dose 1
|
17 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Myalgia, Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Myalgia, Dose 1
|
16 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Shivering, Dose 1
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Shivering, Dose 1
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Shivering, Dose 1
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Fatigue, Dose 2
|
17 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Fatigue, Dose 2
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Fatigue, Dose 2
|
17 Participants
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Gastrointestinal Symptoms, Dose 2
|
7 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Gastrointestinal Symptoms, Dose 2
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Gastrointestinal Symptoms, Dose 2
|
7 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Headache, Dose 2
|
20 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Headache, Dose 2
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Headache, Dose 2
|
20 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Malaise, Dose 2
|
14 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Malaise, Dose 2
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Malaise, Dose 2
|
14 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Myalgia, Dose 2
|
19 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Myalgia, Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Myalgia, Dose 2
|
19 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Shivering, Dose 2
|
14 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Shivering, Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Shivering, Dose 2
|
14 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Fatigue, Dose 3
|
—
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Fatigue, Dose 3
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Fatigue, Dose 3
|
—
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Gastrointestinal Symptoms, Dose 3
|
—
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Gastrointestinal Symptoms, Dose 3
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Gastrointestinal Symptoms, Dose 3
|
—
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Headache, Dose 3
|
—
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Headache, Dose 3
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Headache, Dose 3
|
—
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Malaise, Dose 3
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Malaise, Dose 3
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Malaise, Dose 3
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Myalgia, Dose 3
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Myalgia, Dose 3
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Myalgia, Dose 3
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Shivering, Dose 3
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Shivering, Dose 3
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Shivering, Dose 3
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Fatigue, Across doses
|
18 Participants
|
12 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Fatigue, Across doses
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Fatigue, Across doses
|
18 Participants
|
11 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Gastrointestinal Symptoms, Across doses
|
14 Participants
|
12 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Gastrointestinal Symptoms, Across doses
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Gastrointestinal Symptoms, Across doses
|
14 Participants
|
11 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Headache, Across doses
|
26 Participants
|
11 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Headache, Across doses
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Headache, Across doses
|
24 Participants
|
10 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Malaise, Across doses
|
15 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Malaise, Across doses
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Malaise, Across doses
|
15 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Myalgia, Across doses
|
23 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Myalgia, Across doses
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Myalgia, Across doses
|
22 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Shivering, Across doses
|
16 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Shivering, Across doses
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Shivering, Across doses
|
16 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Within the 28-day (Days 0-27) and post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs) - Step 2
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Within the 28-day (Days 0-27) post-vaccination period.Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=38 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=40 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs) - Pooling Step
|
20 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Up to Day 180 for the HBsAg/AS_2 Group and up to Day 330 for the Engerix-B_2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs) - Step 2
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=38 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=40 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs) - Pooling Step
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Day 180 for the HBsAg/AS_2 Group and up to Day 330 for the Engerix-B_2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented
PIMD(s) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Number of Subjects With Any Potential Immune-mediated Disorders (pIMDs) - Step 2
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
PIMD(s) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=38 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=40 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Number of Subjects With Any Potential Immune-mediated Disorders (pIMDs) - Pooling Step
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 180 for the HBsAg/AS_2 Group and up to Day 330 for the Engerix-B_2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Number of Subjects With Any New Medical Conditions Requiring Medical Attention (MAEs) - Step 2
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=38 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=40 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Number of Subjects With Any New Medical Conditions Requiring Medical Attention (MAEs) - Pooling Step
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Biochemical laboratory parameters assessed included ALT levels. ALT concentrations were expressed in units per liter (U/L).
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 2
ALT, PRE
|
27.5 U/L
Interval 23.0 to 33.0
|
31 U/L
Interval 28.0 to 38.0
|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 2
ALT, D30
|
25.5 U/L
Interval 25.0 to 31.0
|
—
|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 2
ALT, D32
|
27 U/L
Interval 20.0 to 36.0
|
—
|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 2
ALT, D37
|
23 U/L
Interval 18.0 to 31.0
|
—
|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 2
ALT, D60
|
30 U/L
Interval 23.0 to 33.0
|
—
|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 2
ALT, D180
|
—
|
34.5 U/L
Interval 27.0 to 45.0
|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 2
ALT, D182
|
—
|
31 U/L
Interval 25.0 to 42.0
|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 2
ALT, D187
|
—
|
34 U/L
Interval 29.0 to 40.0
|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 2
ALT, D210
|
—
|
29.5 U/L
Interval 22.0 to 48.0
|
SECONDARY outcome
Timeframe: At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Biochemical laboratory parameters assessed included AST levels. AST concentrations were expressed in units per liter (U/L).
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 2
AST, PRE
|
22.5 U/L
Interval 21.0 to 24.0
|
28 U/L
Interval 23.0 to 38.0
|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 2
AST, D30
|
22.5 U/L
Interval 20.0 to 26.0
|
—
|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 2
AST, D32
|
24 U/L
Interval 22.0 to 26.0
|
—
|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 2
AST, D37
|
20.5 U/L
Interval 18.0 to 24.0
|
—
|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 2
AST, D60
|
21.5 U/L
Interval 18.0 to 31.0
|
—
|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 2
AST, D180
|
—
|
25 U/L
Interval 18.0 to 43.0
|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 2
AST, D182
|
—
|
29 U/L
Interval 23.0 to 39.0
|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 2
AST, D187
|
—
|
25 U/L
Interval 20.0 to 36.0
|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 2
AST, D210
|
—
|
22.5 U/L
Interval 20.0 to 28.0
|
SECONDARY outcome
Timeframe: At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Haematological laboratory parameters assessed included basophil levels. Basophil levels were expressed in billion cells per liter (billion cells/L).
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Basophils in Blood Samples - Step 2
Basophils, PRE
|
0.04 billion cells/L
Interval 0.02 to 0.05
|
0.03 billion cells/L
Interval 0.02 to 0.04
|
|
Levels of Basophils in Blood Samples - Step 2
Basophils, D30
|
0.02 billion cells/L
Interval 0.01 to 0.07
|
—
|
|
Levels of Basophils in Blood Samples - Step 2
Basophils, D32
|
0.04 billion cells/L
Interval 0.02 to 0.05
|
—
|
|
Levels of Basophils in Blood Samples - Step 2
Basophils, D37
|
0.03 billion cells/L
Interval 0.01 to 0.06
|
—
|
|
Levels of Basophils in Blood Samples - Step 2
Basophils, D60
|
0.05 billion cells/L
Interval 0.02 to 0.06
|
—
|
|
Levels of Basophils in Blood Samples - Step 2
Basophils, D180
|
—
|
0.02 billion cells/L
Interval 0.01 to 0.04
|
|
Levels of Basophils in Blood Samples - Step 2
Basophils, D182
|
—
|
0.02 billion cells/L
Interval 0.01 to 0.04
|
|
Levels of Basophils in Blood Samples - Step 2
Basophils, D187
|
—
|
0.03 billion cells/L
Interval 0.02 to 0.05
|
|
Levels of Basophils in Blood Samples - Step 2
Basophils, D210
|
—
|
0.03 billion cells/L
Interval 0.01 to 0.04
|
SECONDARY outcome
Timeframe: At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Biochemical laboratory parameters assessed included CRP levels. CRP concentrations were expressed in milligrams per liter (mg/L).
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2
CRP, PRE
|
5.55 mg/L
Interval 5.0 to 6.8
|
5.8 mg/L
Interval 5.0 to 9.5
|
|
Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2
CRP, D2
|
24.2 mg/L
Interval 16.6 to 32.7
|
5 mg/L
Interval 5.0 to 8.8
|
|
Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2
CRP, D30
|
6.8 mg/L
Interval 5.1 to 8.2
|
—
|
|
Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2
CRP, D31
|
20.45 mg/L
Interval 10.4 to 21.9
|
—
|
|
Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2
CRP, D32
|
33.75 mg/L
Interval 12.7 to 44.6
|
—
|
|
Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2
CRP, D37
|
6.7 mg/L
Interval 5.5 to 10.0
|
—
|
|
Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2
CRP, D60
|
5 mg/L
Interval 5.0 to 6.2
|
—
|
|
Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2
CRP, D180
|
—
|
5.25 mg/L
Interval 5.0 to 6.8
|
|
Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2
CRP, D181
|
—
|
5 mg/L
Interval 5.0 to 6.0
|
|
Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2
CRP, D182
|
—
|
5 mg/L
Interval 5.0 to 7.3
|
|
Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2
CRP, D187
|
—
|
5 mg/L
Interval 5.0 to 6.7
|
|
Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2
CRP, D210
|
—
|
5 mg/L
Interval 5.0 to 7.8
|
SECONDARY outcome
Timeframe: At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Haematological laboratory parameters assessed included eosinophil levels. Eosinophil levels were expressed in billion cells per liter (billion cells/L).
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Eosinophils in Blood Samples - Step 2
Eosinophils, PRE
|
0.16 billion cells/L
Interval 0.09 to 0.23
|
0.18 billion cells/L
Interval 0.1 to 0.29
|
|
Levels of Eosinophils in Blood Samples - Step 2
Eosinophils, D30
|
0.17 billion cells/L
Interval 0.12 to 0.23
|
—
|
|
Levels of Eosinophils in Blood Samples - Step 2
Eosinophils, D32
|
0.25 billion cells/L
Interval 0.17 to 0.33
|
—
|
|
Levels of Eosinophils in Blood Samples - Step 2
Eosinophils, D37
|
0.19 billion cells/L
Interval 0.11 to 0.26
|
—
|
|
Levels of Eosinophils in Blood Samples - Step 2
Eosinophils, D60
|
0.2 billion cells/L
Interval 0.09 to 0.26
|
—
|
|
Levels of Eosinophils in Blood Samples - Step 2
Eosinophils, D180
|
—
|
0.14 billion cells/L
Interval 0.1 to 0.2
|
|
Levels of Eosinophils in Blood Samples - Step 2
Eosinophils, D182
|
—
|
0.17 billion cells/L
Interval 0.11 to 0.19
|
|
Levels of Eosinophils in Blood Samples - Step 2
Eosinophils, D187
|
—
|
0.18 billion cells/L
Interval 0.16 to 0.27
|
|
Levels of Eosinophils in Blood Samples - Step 2
Eosinophils, D210
|
—
|
0.16 billion cells/L
Interval 0.09 to 0.26
|
SECONDARY outcome
Timeframe: At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Haematological laboratory parameters assessed included white blood cells levels. WBC levels were expressed in billion cells per liter (billion cells/L).
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of White Blood Cell (WBC) in Blood Samples - Step 2
WBC, PRE
|
6.93 billion cells/L
Interval 5.51 to 9.67
|
5.67 billion cells/L
Interval 5.13 to 7.46
|
|
Levels of White Blood Cell (WBC) in Blood Samples - Step 2
WBC, D30
|
6.41 billion cells/L
Interval 5.7 to 6.6
|
—
|
|
Levels of White Blood Cell (WBC) in Blood Samples - Step 2
WBC, D32
|
6.29 billion cells/L
Interval 5.24 to 8.09
|
—
|
|
Levels of White Blood Cell (WBC) in Blood Samples - Step 2
WBC, D37
|
6.37 billion cells/L
Interval 5.42 to 7.06
|
—
|
|
Levels of White Blood Cell (WBC) in Blood Samples - Step 2
WBC, D60
|
7.03 billion cells/L
Interval 5.65 to 8.5
|
—
|
|
Levels of White Blood Cell (WBC) in Blood Samples - Step 2
WBC, D180
|
—
|
6.02 billion cells/L
Interval 5.25 to 8.3
|
|
Levels of White Blood Cell (WBC) in Blood Samples - Step 2
WBC, D182
|
—
|
6.15 billion cells/L
Interval 5.6 to 8.1
|
|
Levels of White Blood Cell (WBC) in Blood Samples - Step 2
WBC, D187
|
—
|
7.35 billion cells/L
Interval 5.46 to 7.61
|
|
Levels of White Blood Cell (WBC) in Blood Samples - Step 2
WBC, D210
|
—
|
5.91 billion cells/L
Interval 4.48 to 8.53
|
SECONDARY outcome
Timeframe: At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Haematological laboratory parameters assessed included lymphocyte levels. Lymphocyte levels were expressed in billion cells per liter (billion cells/L).
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Lymphocytes in Blood Samples - Step 2
Lymphocytes, D0
|
2.13 billion cells/L
Interval 1.83 to 2.55
|
1.96 billion cells/L
Interval 1.69 to 2.37
|
|
Levels of Lymphocytes in Blood Samples - Step 2
Lymphocytes, D30
|
2.14 billion cells/L
Interval 1.8 to 2.47
|
—
|
|
Levels of Lymphocytes in Blood Samples - Step 2
Lymphocytes, D32
|
1.7 billion cells/L
Interval 1.47 to 1.82
|
—
|
|
Levels of Lymphocytes in Blood Samples - Step 2
Lymphocytes, D37
|
2.12 billion cells/L
Interval 1.98 to 2.32
|
—
|
|
Levels of Lymphocytes in Blood Samples - Step 2
Lymphocytes, D60
|
2.12 billion cells/L
Interval 1.72 to 2.34
|
—
|
|
Levels of Lymphocytes in Blood Samples - Step 2
Lymphocytes, D180
|
—
|
1.93 billion cells/L
Interval 1.84 to 2.45
|
|
Levels of Lymphocytes in Blood Samples - Step 2
Lymphocytes, D182
|
—
|
2.04 billion cells/L
Interval 1.75 to 2.44
|
|
Levels of Lymphocytes in Blood Samples - Step 2
Lymphocytes, D187
|
—
|
2.07 billion cells/L
Interval 1.76 to 2.27
|
|
Levels of Lymphocytes in Blood Samples - Step 2
Lymphocytes, D210
|
—
|
1.91 billion cells/L
Interval 1.46 to 2.94
|
SECONDARY outcome
Timeframe: At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Haematological laboratory parameters assessed included monocyte levels. Monocyte levels were expressed in billion cells per liter (billion cells/L).
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Monocytes in Blood Samples - Step 2
Monocytes, D0
|
0.64 billion cells/L
Interval 0.47 to 0.74
|
0.5 billion cells/L
Interval 0.28 to 0.69
|
|
Levels of Monocytes in Blood Samples - Step 2
Monocytes, D30
|
0.54 billion cells/L
Interval 0.38 to 0.62
|
—
|
|
Levels of Monocytes in Blood Samples - Step 2
Monocytes, D32
|
0.87 billion cells/L
Interval 0.8 to 1.07
|
—
|
|
Levels of Monocytes in Blood Samples - Step 2
Monocytes, D37
|
0.47 billion cells/L
Interval 0.43 to 0.58
|
—
|
|
Levels of Monocytes in Blood Samples - Step 2
Monocytes, D60
|
0.58 billion cells/L
Interval 0.49 to 0.68
|
—
|
|
Levels of Monocytes in Blood Samples - Step 2
Monocytes, D180
|
—
|
0.46 billion cells/L
Interval 0.39 to 0.57
|
|
Levels of Monocytes in Blood Samples - Step 2
Monocytes, D182
|
—
|
0.43 billion cells/L
Interval 0.42 to 0.66
|
|
Levels of Monocytes in Blood Samples - Step 2
Monocytes, D187
|
—
|
0.44 billion cells/L
Interval 0.37 to 0.55
|
|
Levels of Monocytes in Blood Samples - Step 2
Monocytes, D210
|
—
|
0.52 billion cells/L
Interval 0.34 to 0.62
|
SECONDARY outcome
Timeframe: At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Haematological laboratory parameters assessed included neutrophil levels. Neutrophil levels were expressed in billion cells per liter (billion cells/L).
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Neutrophils in Blood Samples - Step 2
Neutrophils, D0
|
4.02 billion cells/L
Interval 3.12 to 6.22
|
3.11 billion cells/L
Interval 2.3 to 4.56
|
|
Levels of Neutrophils in Blood Samples - Step 2
Neutrophils, D30
|
3.41 billion cells/L
Interval 2.87 to 3.93
|
—
|
|
Levels of Neutrophils in Blood Samples - Step 2
Neutrophils, D32
|
3.42 billion cells/L
Interval 2.78 to 5.01
|
—
|
|
Levels of Neutrophils in Blood Samples - Step 2
Neutrophils, D37
|
3.22 billion cells/L
Interval 2.76 to 3.9
|
—
|
|
Levels of Neutrophils in Blood Samples - Step 2
Neutrophils, D60
|
4.18 billion cells/L
Interval 2.96 to 5.34
|
—
|
|
Levels of Neutrophils in Blood Samples - Step 2
Neutrophils, D180
|
—
|
3.29 billion cells/L
Interval 2.99 to 4.67
|
|
Levels of Neutrophils in Blood Samples - Step 2
Neutrophils, D182
|
—
|
3.16 billion cells/L
Interval 2.89 to 4.88
|
|
Levels of Neutrophils in Blood Samples - Step 2
Neutrophils, D187
|
—
|
3.9 billion cells/L
Interval 3.18 to 4.29
|
|
Levels of Neutrophils in Blood Samples - Step 2
Neutrophils, D210
|
—
|
3.28 billion cells/L
Interval 2.29 to 4.88
|
SECONDARY outcome
Timeframe: At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Haematological laboratory parameters assessed included platelet count levels. Platelet count levels were expressed in billion cells per liter (billion cells/L).
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Platelet Count in Blood Samples - Step 2
Platelets, D0
|
269 billion cells/L
Interval 255.0 to 312.0
|
272 billion cells/L
Interval 215.0 to 322.0
|
|
Platelet Count in Blood Samples - Step 2
Platelets, D30
|
272.5 billion cells/L
Interval 215.0 to 330.0
|
—
|
|
Platelet Count in Blood Samples - Step 2
Platelets, D32
|
257 billion cells/L
Interval 204.0 to 303.0
|
—
|
|
Platelet Count in Blood Samples - Step 2
Platelets, D37
|
315.5 billion cells/L
Interval 286.0 to 330.0
|
—
|
|
Platelet Count in Blood Samples - Step 2
Platelets, D60
|
282 billion cells/L
Interval 257.0 to 323.0
|
—
|
|
Platelet Count in Blood Samples - Step 2
Platelets, D180
|
—
|
247 billion cells/L
Interval 237.0 to 276.0
|
|
Platelet Count in Blood Samples - Step 2
Platelets, D182
|
—
|
263 billion cells/L
Interval 248.0 to 274.0
|
|
Platelet Count in Blood Samples - Step 2
Platelets, D187
|
—
|
272 billion cells/L
Interval 260.0 to 280.0
|
|
Platelet Count in Blood Samples - Step 2
Platelets, D210
|
—
|
264.5 billion cells/L
Interval 214.0 to 314.0
|
SECONDARY outcome
Timeframe: At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Biochemical laboratory parameters assessed included total bilirubin levels. Bilirubin concentrations were expressed in milligrams per deciliter (mG/dL).
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Total Bilirubin in Blood Samples - Step 2
Total Bilirubin, PRE
|
0.4 mg/dL
Interval 0.4 to 0.8
|
0.5 mg/dL
Interval 0.3 to 0.7
|
|
Levels of Total Bilirubin in Blood Samples - Step 2
Total Bilirubin, D2
|
0.45 mg/dL
Interval 0.4 to 0.6
|
0.5 mg/dL
Interval 0.3 to 1.5
|
|
Levels of Total Bilirubin in Blood Samples - Step 2
Total Bilirubin, D30
|
0.45 mg/dL
Interval 0.3 to 0.8
|
—
|
|
Levels of Total Bilirubin in Blood Samples - Step 2
Total Bilirubin, D31
|
0.55 mg/dL
Interval 0.4 to 1.0
|
—
|
|
Levels of Total Bilirubin in Blood Samples - Step 2
Total Bilirubin, D32
|
0.4 mg/dL
Interval 0.2 to 0.6
|
—
|
|
Levels of Total Bilirubin in Blood Samples - Step 2
Total Bilirubin, D37
|
0.45 mg/dL
Interval 0.3 to 0.6
|
—
|
|
Levels of Total Bilirubin in Blood Samples - Step 2
Total Bilirubin, D60
|
0.4 mg/dL
Interval 0.3 to 0.6
|
—
|
|
Levels of Total Bilirubin in Blood Samples - Step 2
Total Bilirubin, D180
|
—
|
0.45 mg/dL
Interval 0.4 to 0.6
|
|
Levels of Total Bilirubin in Blood Samples - Step 2
Total Bilirubin, D181
|
—
|
0.6 mg/dL
Interval 0.4 to 0.7
|
|
Levels of Total Bilirubin in Blood Samples - Step 2
Total Bilirubin, D182
|
—
|
0.6 mg/dL
Interval 0.5 to 0.7
|
|
Levels of Total Bilirubin in Blood Samples - Step 2
Total Bilirubin, D187
|
—
|
0.5 mg/dL
Interval 0.5 to 0.7
|
|
Levels of Total Bilirubin in Blood Samples - Step 2
Total Bilirubin, D210
|
—
|
0.6 mg/dL
Interval 0.5 to 0.7
|
SECONDARY outcome
Timeframe: At Day 0 (PRE), Day 30 (H0, H6) at Day 31, at Day 32, at Day 37, at Day 60 for the HBsAg/AS_2 Group and at Day 0 (PRE), Day 180 (H0, H6), Day 181, at Day 182, at Day 187 and at Day 210 for the Engerix-B_2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Diastolic pressure was part of the list of vital signs followed at specific protocol-defined time points during this study, measured in millimeter of mercury (mmHg). On Days 30 and 180, diastolic blood pressure was assessed at multiple time points (plus 0 and 6 hours - H0, H6).
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Diastolic Blood Pressure - Step 2
Diastolic, D0
|
74 mmHg
Interval 69.0 to 75.0
|
70 mmHg
Interval 67.0 to 72.0
|
|
Levels of Diastolic Blood Pressure - Step 2
Diastolic, D30 H0
|
74.5 mmHg
Interval 73.0 to 78.0
|
—
|
|
Levels of Diastolic Blood Pressure - Step 2
Diastolic, D30 H6
|
71 mmHg
Interval 69.0 to 75.0
|
—
|
|
Levels of Diastolic Blood Pressure - Step 2
Diastolic, D31
|
71.5 mmHg
Interval 68.0 to 78.0
|
—
|
|
Levels of Diastolic Blood Pressure - Step 2
Diastolic, D32
|
71.5 mmHg
Interval 66.0 to 82.0
|
—
|
|
Levels of Diastolic Blood Pressure - Step 2
Diastolic, D37
|
70 mmHg
Interval 69.0 to 76.0
|
—
|
|
Levels of Diastolic Blood Pressure - Step 2
Diastolic, D60
|
72 mmHg
Interval 68.0 to 77.0
|
—
|
|
Levels of Diastolic Blood Pressure - Step 2
Diastolic, D180 H0
|
—
|
69 mmHg
Interval 63.0 to 71.0
|
|
Levels of Diastolic Blood Pressure - Step 2
Diastolic, D180 H6
|
—
|
68.5 mmHg
Interval 65.0 to 71.0
|
|
Levels of Diastolic Blood Pressure - Step 2
Diastolic, D181
|
—
|
72 mmHg
Interval 66.0 to 75.0
|
|
Levels of Diastolic Blood Pressure - Step 2
Diastolic, D182
|
—
|
70 mmHg
Interval 69.0 to 72.0
|
|
Levels of Diastolic Blood Pressure - Step 2
Diastolic, D187
|
—
|
72 mmHg
Interval 64.0 to 77.0
|
|
Levels of Diastolic Blood Pressure - Step 2
Diastolic, D210
|
—
|
71.5 mmHg
Interval 65.0 to 74.0
|
SECONDARY outcome
Timeframe: At Day 0 (PRE), Day 30 (H0, H6) at Day 31, at Day 32, at Day 37, at Day 60 for the HBsAg/AS_2 Group and at Day 0 (PRE), Day 180 (H0, H6), Day 181, at Day 182, at Day 187 and at Day 210 for the Engerix-B_2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Heart rate was part of the list of vital signs followed at specific protocol-defined time points during this study. It was expressed in beats per minute. On Days 30 and 180, heart rate was assessed at multiple time points (plus 0 and 6 hours - H0, H6).
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Heart Rate - Step 2
Heart rate, PRE
|
72 beats/minute
Interval 63.0 to 80.0
|
70 beats/minute
Interval 62.0 to 80.0
|
|
Levels of Heart Rate - Step 2
Heart rate, D30 H0
|
70 beats/minute
Interval 65.0 to 81.0
|
—
|
|
Levels of Heart Rate - Step 2
Heart rate, D30 H6
|
68 beats/minute
Interval 64.0 to 77.0
|
—
|
|
Levels of Heart Rate - Step 2
Heart rate, D31
|
84 beats/minute
Interval 70.0 to 90.0
|
—
|
|
Levels of Heart Rate - Step 2
Heart rate, D32
|
73 beats/minute
Interval 67.0 to 83.0
|
—
|
|
Levels of Heart Rate - Step 2
Heart rate, D37
|
65 beats/minute
Interval 56.0 to 73.0
|
—
|
|
Levels of Heart Rate - Step 2
Heart rate, D60
|
65 beats/minute
Interval 62.0 to 72.0
|
—
|
|
Levels of Heart Rate - Step 2
Heart rate, D180 H0
|
—
|
71.5 beats/minute
Interval 63.0 to 86.0
|
|
Levels of Heart Rate - Step 2
Heart rate, D180 H6
|
—
|
70 beats/minute
Interval 58.0 to 80.0
|
|
Levels of Heart Rate - Step 2
Heart rate, D181
|
—
|
81 beats/minute
Interval 73.0 to 91.0
|
|
Levels of Heart Rate - Step 2
Heart rate, D182
|
—
|
72 beats/minute
Interval 71.0 to 83.0
|
|
Levels of Heart Rate - Step 2
Heart rate, D187
|
—
|
78 beats/minute
Interval 67.0 to 84.0
|
|
Levels of Heart Rate - Step 2
Heart rate, D210
|
—
|
76.5 beats/minute
Interval 68.0 to 79.0
|
SECONDARY outcome
Timeframe: At Day 0 (PRE), Day 30 (H0, H6) at Day 31, at Day 32, at Day 37, at Day 60 for the HBsAg/AS_2 Group and at Day 0 (PRE), Day 180 (H0, H6), Day 181, at Day 182, at Day 187 and at Day 210 for the Engerix-B_2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Respiratory Rate was part of the list of vital signs followed at specific protocol-defined time points during this study. It was expressed as breaths per minute (breaths/min). On Days 30 and 180, respiratory rate was assessed at multiple time points (plus 0 and 6 hours - H0, H6).
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Respiratory Rate - Step 2
Respiratory rate, PRE
|
12 breaths/min
Interval 12.0 to 14.0
|
12 breaths/min
Interval 12.0 to 14.0
|
|
Levels of Respiratory Rate - Step 2
Respiratory rate, D30 H0
|
12.5 breaths/min
Interval 11.0 to 13.0
|
—
|
|
Levels of Respiratory Rate - Step 2
Respiratory rate, D30 H6
|
12 breaths/min
Interval 12.0 to 14.0
|
—
|
|
Levels of Respiratory Rate - Step 2
Respiratory rate, D31
|
13 breaths/min
Interval 12.0 to 14.0
|
—
|
|
Levels of Respiratory Rate - Step 2
Respiratory rate, D32
|
12 breaths/min
Interval 12.0 to 13.0
|
—
|
|
Levels of Respiratory Rate - Step 2
Respiratory rate, D37
|
13.5 breaths/min
Interval 12.0 to 14.0
|
—
|
|
Levels of Respiratory Rate - Step 2
Respiratory rate, D60
|
12 breaths/min
Interval 12.0 to 13.0
|
—
|
|
Levels of Respiratory Rate - Step 2
Respiratory rate, D180 H0
|
—
|
12.5 breaths/min
Interval 12.0 to 15.0
|
|
Levels of Respiratory Rate - Step 2
Respiratory rate, D180 H6
|
—
|
12.5 breaths/min
Interval 12.0 to 14.0
|
|
Levels of Respiratory Rate - Step 2
Respiratory rate, D181
|
—
|
12 breaths/min
Interval 12.0 to 14.0
|
|
Levels of Respiratory Rate - Step 2
Respiratory rate, D182
|
—
|
13 breaths/min
Interval 12.0 to 14.0
|
|
Levels of Respiratory Rate - Step 2
Respiratory rate, D187
|
—
|
13 breaths/min
Interval 12.0 to 15.0
|
|
Levels of Respiratory Rate - Step 2
Respiratory rate, D210
|
—
|
13.5 breaths/min
Interval 12.0 to 15.0
|
SECONDARY outcome
Timeframe: At Day 0 (PRE), Day 30 (H0, H6) at Day 31, at Day 32, at Day 37, at Day 60 for the HBsAg/AS_2 Group and at Day 0 (PRE), Day 180 (H0, H6), Day 181, at Day 182, at Day 187 and at Day 210 for the Engerix-B_2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Systolic pressure was part of the list of vital signs followed at specific protocol-defined time points during this study, measured in millimeter of mercury (mmHg). On Days 30 and 180, systolic pressure was assessed at multiple time points (plus 0 and 6 hours - H0, H6).
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Systolic Pressure - Step 2
Systolic, D210
|
—
|
112 mmHg
Interval 108.0 to 116.0
|
|
Levels of Systolic Pressure - Step 2
Systolic, PRE
|
114 mmHg
Interval 110.0 to 116.0
|
112 mmHg
Interval 103.0 to 115.0
|
|
Levels of Systolic Pressure - Step 2
Systolic, D37
|
108.5 mmHg
Interval 105.0 to 117.0
|
—
|
|
Levels of Systolic Pressure - Step 2
Systolic, D60
|
113 mmHg
Interval 104.0 to 122.0
|
—
|
|
Levels of Systolic Pressure - Step 2
Systolic, D180 H0
|
—
|
111.5 mmHg
Interval 105.0 to 119.0
|
|
Levels of Systolic Pressure - Step 2
Systolic, D180 H6
|
—
|
111.5 mmHg
Interval 108.0 to 114.0
|
|
Levels of Systolic Pressure - Step 2
Systolic, D181
|
—
|
115 mmHg
Interval 112.0 to 129.0
|
|
Levels of Systolic Pressure - Step 2
Systolic, D182
|
—
|
117 mmHg
Interval 108.0 to 120.0
|
|
Levels of Systolic Pressure - Step 2
Systolic, D187
|
—
|
112 mmHg
Interval 110.0 to 115.0
|
|
Levels of Systolic Pressure - Step 2
Systolic, D30 H0
|
114 mmHg
Interval 109.0 to 118.0
|
—
|
|
Levels of Systolic Pressure - Step 2
Systolic, D30 H6
|
116 mmHg
Interval 104.0 to 121.0
|
—
|
|
Levels of Systolic Pressure - Step 2
Systolic, D31
|
112 mmHg
Interval 108.0 to 113.0
|
—
|
|
Levels of Systolic Pressure - Step 2
Systolic, D32
|
111.5 mmHg
Interval 102.0 to 116.0
|
—
|
SECONDARY outcome
Timeframe: At Day 0 prior to vaccination (PRE) and Day 44 post-vaccinationPopulation: The analysis was performed on the ATP cohort for adaptive immunogenicity up to Day 60 (step 1 only) which included all evaluable subjects who complied with the protocol and for whom data concerning adaptive immunogenicity were available for at least one adaptive assay at one post-vaccination time point (up to Day 60).
Markers expressed were Interleukin-2 (IL-2), Interferon gamma (IFN-γ), Tumor Necrosis Factor (TNF)-α and Cluster of differentiation 40-Ligand (CD40L), as measured by classical (qualified assay) Intracellular Cytokine Staining (ICS),using frozen Peripheral blood mononuclear cells (PBMCs).
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=26 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=25 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
-Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Immune Markers - Step 1
PRE
|
8 T cells/million cells
Interval 1.0 to 52.0
|
1 T cells/million cells
Interval 1.0 to 18.0
|
|
-Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Immune Markers - Step 1
Day 44
|
4494 T cells/million cells
Interval 2441.0 to 7494.0
|
268 T cells/million cells
Interval 76.0 to 509.0
|
SECONDARY outcome
Timeframe: At Day 0 prior to vaccination (PRE), Day 44 and Day 180 post-vaccinationPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence (step 1 only) included all evaluable subjects, who complied with the protocol, for whom data concerning adaptive immunogenicity were available for at least one adaptive assay at Day 180.
Markers expressed were Interleukin-2 (IL-2), Interferon gamma (IFN-γ), Tumor Necrosis Factor (TNF)-α and Cluster of differentiation 40-Ligand (CD40L), as measured by classical (qualified assay) Intracellular Cytokine Staining (ICS),using frozen Peripheral blood mononuclear cells (PBMCs).
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=24 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Immune Markers - Step 1
PRE
|
8 T cells/ million cells
Interval 1.0 to 52.0
|
1 T cells/ million cells
Interval 1.0 to 21.0
|
|
Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Immune Markers - Step 1
Day 44
|
4494 T cells/ million cells
Interval 2441.0 to 7494.0
|
260 T cells/ million cells
Interval 33.0 to 527.0
|
|
Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Immune Markers - Step 1
Day 180
|
1119 T cells/ million cells
Interval 748.0 to 2181.0
|
34 T cells/ million cells
Interval 1.0 to 155.0
|
SECONDARY outcome
Timeframe: At Day 0 prior to vaccination (PRE) and Day 44 post-vaccinationPopulation: The analysis was performed on the ATP cohort for adaptive immunogenicity up to Day 60 (step 1 only) which included all evaluable subjects who complied with the protocol and for whom data concerning adaptive immunogenicity were available for at least one adaptive assay at one post-vaccination time point (up to Day 60).
Markers expressed were Interleukin-2 (IL-2), Interferon gamma (IFN-γ), Tumor Necrosis Factor (TNF)-α and Cluste of differentiation 40-Ligand (CD40L), as measured by classical (qualified assay) Intracellular Cytokine Staining (ICS),using frozen Peripheral blood mononuclear cells (PBMCs).
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=26 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=25 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)8+ T-cells Expressing at Least 2 Immune Markers - Step 1
PRE
|
1 T cells/ million cells
Interval 1.0 to 24.0
|
1 T cells/ million cells
Interval 1.0 to 1.0
|
|
Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)8+ T-cells Expressing at Least 2 Immune Markers - Step 1
Day 44
|
38 T cells/ million cells
Interval 1.0 to 108.0
|
1 T cells/ million cells
Interval 1.0 to 33.0
|
SECONDARY outcome
Timeframe: At Day 0 prior to vaccination (PRE), Day 44 and Day 180 post-vaccinationPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence (step 1 only) included all evaluable subjects, who complied with the protocol, for whom data concerning adaptive immunogenicity were available for at least one adaptive assay at Day 180.
Markers expressed were Interleukin-2 (IL-2), Interferon gamma (IFN-γ), Tumor Necrosis Factor (TNF)-α and Cluster of differentiation 40-Ligand (CD40L), as measured by classical (qualified assay) Intracellular Cytokine Staining (ICS),using frozen Peripheral blood mononuclear cells (PBMCs).
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=24 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)8+ T-cells Expressing at Least 2 Immune Markers - Step 1
PRE
|
1 T ceclls/ million cells
Interval 1.0 to 24.0
|
1 T ceclls/ million cells
Interval 1.0 to 1.0
|
|
Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)8+ T-cells Expressing at Least 2 Immune Markers - Step 1
Day 44
|
38 T ceclls/ million cells
Interval 1.0 to 108.0
|
1 T ceclls/ million cells
Interval 1.0 to 42.0
|
|
Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)8+ T-cells Expressing at Least 2 Immune Markers - Step 1
Day 180
|
1 T ceclls/ million cells
Interval 1.0 to 17.0
|
1 T ceclls/ million cells
Interval 1.0 to 31.0
|
SECONDARY outcome
Timeframe: Up to 3 days post-placebo/vaccine administration.Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Assessed solicited symptoms were fever \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], pain, redness \[spreading beyond 20 millimeters (mm) of injection site\], induration \[spreading beyond 20 millimeters (mm) of injection site\], swelling \[spreading beyond 20 millimeters (mm) of injection site\] and muscle stiffness.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2
Pain, Dose 2
|
8 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2
Pain, Dose 3
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2
Redness, Dose 2
|
5 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2
Redness, Dose 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2
Swelling, Dose 2
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2
Swelling, Dose 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2
Induration, Dose 2
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2
Induration, Dose 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2
Fever, Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2
Fever, Dose 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2
Muscle stiffness, Dose 2
|
7 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2
Muscle stiffness, Dose 3
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 3 days post-Dose 2 vaccine administration in HBsAg/AS_1+2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, of the HBsAg/AS\_1+2 Group only, which included all subjects with the vaccine administration documented.
Assessed solicited symptoms were fever \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], pain, redness \[spreading beyond 20 millimeters (mm) of injection site\], induration \[spreading beyond 20 millimeters (mm) of injection site\], swelling \[spreading beyond 20 millimeters (mm) of injection site\] and muscle stiffness.
Outcome measures
| Measure |
HBsAg/AS_1 Group
n=37 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1 Group
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Pooling Step
Pain
|
26 Participants
|
—
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Pooling Step
Redness
|
12 Participants
|
—
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Pooling Step
Swelling
|
7 Participants
|
—
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Pooling Step
Induration
|
2 Participants
|
—
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Pooling Step
Muscle stiffness
|
22 Participants
|
—
|
Adverse Events
HBsAg/AS_1+2 Group
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Engerix-B_1+2 Group
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HBsAg/AS_1+2 Group
n=38 participants at risk
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30; and during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1+2 Group
n=40 participants at risk
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180; and during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/38 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
2.5%
1/40 • Number of events 1 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
Other adverse events
| Measure |
HBsAg/AS_1+2 Group
n=38 participants at risk
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30; and during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1+2 Group
n=40 participants at risk
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180; and during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.9%
3/38 • Number of events 3 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
0.00%
0/40 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/38 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
7.5%
3/40 • Number of events 3 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
|
General disorders
Fatigue
|
0.00%
0/38 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
5.0%
2/40 • Number of events 2 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
|
Nervous system disorders
Headache
|
5.3%
2/38 • Number of events 3 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
12.5%
5/40 • Number of events 5 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
|
General disorders
Influenza like illness
|
5.3%
2/38 • Number of events 2 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
0.00%
0/40 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
|
Nervous system disorders
Migraine
|
0.00%
0/38 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
5.0%
2/40 • Number of events 5 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
|
Infections and infestations
Nasopharyngitis
|
13.2%
5/38 • Number of events 5 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
2.5%
1/40 • Number of events 1 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
|
Infections and infestations
Oral herpes
|
5.3%
2/38 • Number of events 2 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
2.5%
1/40 • Number of events 1 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
15.8%
6/38 • Number of events 7 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
2.5%
1/40 • Number of events 1 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/38 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
5.0%
2/40 • Number of events 2 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
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