Clinical trial NCT01777295: 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
Official title: Development of Read-outs to Detect and Characterise the Early and Adaptive Immune Responses in Healthy, Hepatitis B Virus Naive Adults Vaccinated With the Hepatitis B Surface Antigen in Combination With a GSK Biologicals' Adjuvant System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis B
Keywords: Adults
Reactogenicity
Naive
Immune responses
Read-outs
Hepatitis B
Healthy
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Region of Wallonia
name: Public Private Partnership with Institute for Medical Immunology (Universite Libre de Bruxelles)
First posted: 2013-01-28
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to develop innovative immunological read-outs and new technologies in order to further characterise the early immune response and its kinetics as well as the adaptive immune responses to adjuvanted vaccines.

This study will also evaluate the reactogenicity in healthy, hepatitis B virus naive adults vaccinated with the hepatitis B surface antigen in combination with a GSK Biologicals' Adjuvant System.

Detailed description: This study will be conducted in 2 steps with 2 study groups in each step. The entire study period for Step 1 is from Day -30 to Day 210 (240 days) The entire study period for Step 2 is from Day 0 to Day 180 for Group C and from Day 0 to Day 330 for Group D.

Subjects will be blinded up to Day 60 in Step 1 and will be unblinded at the end of their Day 60 visit. Step 2 will be conducted in an open-label manner.

Eligibility criteria: Inclusion Criteria:

* Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol
* A male or female between, and including, 18 and 45 years of age at the time of first study product administration
* Written informed consent obtained from the subject
* Healthy subjects, in the opinion of the investigator, as established by medical history, clinical examination, and clinical laboratory assessment with no active disease that could interfere with the study endpoints, before entering into the study
* Body Mass Index (BMI) between 18.5 and 30 kg/m2
* Female subjects of non-childbearing potential may be enrolled in the study

  - Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
* Female subjects of childbearing potential may be enrolled in the study, if the subject:

  * has practiced adequate contraception for 30 days prior to first study product administration and
  * has a negative pregnancy test on the day of placebo administration/ vaccination, and
  * has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the study.

Exclusion Criteria:

* Known history of HBV infection.
* Previous vaccination against hepatitis B.
* Positive for anti-hepatitis B surface (HBs) antibodies, anti-hepatitis B core (HBc) antibodies, HBsAg, HCV antibodies and/or HIV.
* Any previous administration of vaccine components.
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first study product administration, or planned use during the study period.
* No significant dietary restrictions or life-threatening food allergies.
* Regular use of non steroidal anti-inflammatory drugs within 1 month prior to first study product administration.
* Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first study product administration.. Inhaled and topical steroids are allowed.
* Planned administration / administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first study product administration and during the entire study period (both Steps), with the exception of the influenza vaccine (pandemic or seasonal) which can be administered \> 21 days preceding or \> 21 days following each placebo/vaccine administration.
* Administration of immunoglobulins and/or any blood products within the last 3 months preceding the first study product administration or planned administration during the study period.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV based on screening evaluations and on medical history and physical examination.
* History of or current bleeding or coagulation disorder.
* Any known or clinical signs of anaemia or any clinical condition (including vascular disorder) that would preclude frequent blood drawings.
* Poor venous access as assessed at screening by the investigator.
* Blood loss, including blood donation, of more than 300 mL within 90 days before the first study product administration.
* History of or current autoimmune or other immune-mediated disease.
* Any haematological or biochemical level out of normal range before entering into the study, as follows:
* Haemoglobin level \< lower normal limit (LNL).
* Platelet counts out of normal range.
* Alanine aminotransferase \[ALT\] \> upper normal limit (UNL).
* Aspartate aminotransferase \[AST\] \> UNL.
* Creatinine \> UNL.
* c-reactive protein \[CRP\] \> UNL.
* Creatine phosphokinase \[CPK\] \> UNL without any plausible explanation for this abnormality (such as sport activity).

In case of haematological and/or biochemical value out of range for parameters mentioned here above, one re-testing of out of range value may be performed.

* Any acute or chronic, clinically significant disease, as determined by medical history, physical examination or laboratory screening tests.
* Known or suspected reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
* Acute disease and/or fever at the time of enrolment.
* Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
* Fever is defined as temperature ≥ 37.5°C for oral route.
* Pregnant or lactating female.
* Recent history of chronic alcohol consumption and/or drug abuse.
* Other conditions that the principal investigator judges may interfere with study findings.

Primary outcomes:
measure: Concentrations of Cytokines and Chemokines - Step 1
timeFrame: At Day -30 prior to placebo administration
measure: Cytokines and Chemokines Concentrations - Step 1
timeFrame: Post-placebo at Day -30 plus 1.5 Hours
measure: Concentrations of Cytokines and Chemokines in Step 1
timeFrame: Post-placebo at Day -30 plus 3 Hours
measure: Concentrations of Cytokines and Chemokines During Step 1
timeFrame: Post-placebo at Day -30 plus 6 Hours
measure: Concentrations of Cytokines/Chemokines - Step 1
timeFrame: Post-placebo at Day -30 plus 9 Hours
measure: Concentrations of Cytokines/Chemokines in Step 1
timeFrame: Post-placebo at Day -30 plus 12 Hours
measure: Concentrations of Cytokines/Chemokines During Step 1
timeFrame: Post-placebo at Day -30 plus 18 Hours
measure: Cytokines and Chemokines Concentrations in Step 1
timeFrame: Post-placebo at Day -29
measure: Cytokines and Chemokines Concetrations During Step 1
timeFrame: Post-placebo at Day -28
measure: Cytokines/Chemokines Concentrations in Step 1
timeFrame: Post-placebo at Day -27
measure: Cytokines and Chemokines Concentrations During Step 1
timeFrame: Post-placebo at Day -23
measure: Concentrations of Cytokines and Chemokines - Study Step 1
timeFrame: Pre-dose1 at Day 0
measure: Concentrations of Cytokines and Chemokines in Step 1 of Study
timeFrame: Post-dose1 at Day 0 plus 1.5 Hours
measure: Concentrations of Cytokines and Chemokines During Step 1 of Study
timeFrame: Post-dose1 at Day 0 plus 6 Hours
measure: Cytokines and Chemokines Concentrations - Study Step 1
timeFrame: Post-dose1 at Day 0 plus 12 Hours
measure: Cytokines and Chemokines Concentrations in Step 1 of Study
timeFrame: Post-dose1 at Day 0 plus 18 Hours
measure: Cytokines and Chemokines Concentrations During Step 1 of Study
timeFrame: Post-dose1 at Day 1
measure: Cytokines/Chemokines Concentrations - Study Step 1
timeFrame: Post-dose1 at Day 2
measure: Cytokines/Chemokines Concentrations in Step 1 of Study
timeFrame: Post-dose1 at Day 7
measure: Cytokines/Chemokines Concentrations During Step 1 of Study
timeFrame: Post-dose1 at Day 30
measure: Plasma Concentrations of Cytokines and Chemokines - Step 1
timeFrame: Post-dose 2 at Day 30 plus 1.5 Hours
measure: Plasma Concentrations of Cytokines and Chemokines - Study Step 1
timeFrame: Post-dose 2 at Day 30 plus 3 Hours
measure: Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
timeFrame: Post-dose 2 at Day 30 plus 6 hours
measure: Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
timeFrame: Post-dose 2 at Day 30 plus 9 Hours
measure: Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
timeFrame: Post-dose 2 at Day 30 plus 12 Hours
measure: Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
timeFrame: Post-dose 2 at Day 30 plus 18 Hours
measure: Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
timeFrame: Post-dose 2 at Day 31
measure: Concentrations of Plasma Cytokines and Chemokines - Step 1
timeFrame: Post-dose 2 at Day 32
measure: Concentrations of Plasma Cytokines and Chemokines in Step 1
timeFrame: Post-dose 2 at Day 33
measure: Concentrations of Plasma Cytokines and Chemokines During Step 1
timeFrame: Post-dose 2 at Day 37
measure: Concentrations of Cytokines and Chemokines - Step 2
timeFrame: Pre-dose 1 at Day 0
measure: Cytokines and Chemokines Concentrations - Step 2
timeFrame: Post-dose 1 at Day 1
measure: Concentrations of Cytokines and Chemokines During Step 2
timeFrame: Post-dose 1 at Day 30
measure: Concentrations of Cytokines and Chemokines in Step 2
timeFrame: Post-dose2 at Day 30 plus 6 Hours
measure: Concentrations of Cytokines/Chemokines - Step 2
timeFrame: Post-dose 2 at Day 31
measure: Concentrations of Cytokines/Chemokines in Step 2
timeFrame: Post-dose 2 at Day 37
measure: Concentrations of Cytokines/Chemokines During Step 2
timeFrame: Post-dose 2 at Day 180
measure: Plasma Concentrations of Cytokines and Chemokines - Study Step 2
timeFrame: Post-dose 3 at Day 180 plus 6 Hours
measure: Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
timeFrame: Post-dose 3 at Day 181
measure: Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
timeFrame: Post-dose 3 at Day 187
Secondary outcomes:
measure: Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 1
timeFrame: At Day 0 (PRE) and Day 60 (D60) post-vaccination
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
timeFrame: During the 7-day (Days 0-6) post-placebo (PP) and post-vaccination period following each vaccine dose (D1 and D2) and across doses
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
timeFrame: During the 7-day (Days 0-6) post-placebo (PP) and post-vaccination period following each vaccine dose (D1 and D2) and across doses
measure: Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1
timeFrame: Up to 4 days post-placebo/vaccine administration.
measure: Number of Subjects With Any Unsolicited Adverse Events (AEs) - Step 1
timeFrame: Within the 28-day (Days 0-27) post-placebo (PP) and post-product administration period.
measure: Number of Subjects With Serious Adverse Events (SAEs) - Step 1
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 Group
measure: Number of Subjects With Any Potential Immune-mediated Disorders (pIMDs) - Step 1
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 Group
measure: Number of Subjects With Any New Medical Conditions Requiring Medical Attention (MAEs) - Step 1
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 Group
measure: Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1
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 60
measure: Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1
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 60
measure: Levels of Basophils in Blood Samples - Step 1
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 60
measure: Levels of Total Bilirubin in Blood Samples - Step 1
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 60
measure: Levels of Serum Creatinine in Blood Samples - Step 1
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 60
measure: Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1
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 60
measure: Levels of C-reactive Protein (CRP) in Blood Samples - Step 1
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 60
measure: Levels of Eosinophils in Blood Samples - Step 1
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 60
measure: Levels of Haemoglobin in Blood Samples - Step 1
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 60
measure: Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1
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 60
measure: Levels of Lymphocytes in Blood Samples - Step 1
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 60
measure: Levels of Monocytes in Blood Samples - Step 1
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 60
measure: Levels of Neutrophils in Blood Samples - Step 1
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 60
measure: Platelet Count in Blood Samples - Step 1
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 60
measure: Levels of Red Blood Cell (RBC) in Blood Samples - Step 1
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 60
measure: Levels of Urea in Blood Samples - Step 1
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 60
measure: Levels of White Blood Cells (WBC) - Step 1
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 60
measure: Levels of Diastolic Blood Pressure - Step 1
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 60
measure: Levels of Heart Rate - Step 1
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 60
measure: Levels of Respiratory Rate - Step 1
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 60
measure: Levels of Systolic Pressure - Step 1
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 60
measure: Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 2 Immuno
timeFrame: At Day 0 (PRE) and post-vaccination (Day 44 for HBsAg/AS_2 Group and Day 194 for Engerix-B_2 Group)
measure: Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 2 Persistence
timeFrame: At Day 0 (PRE) and post-vaccination (Day 44 for HBsAg/AS_2 Group and Day 194 for Engerix-B_2 Group)
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
timeFrame: During the 7-day (Days 0-6) post-vaccination period following each vaccine dose and across doses
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
timeFrame: During the 7-day (Days 0-6) post-vaccination period following each vaccine dose and across doses
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
timeFrame: During the 7-day (Days 0-6) post-vaccination period following each vaccine dose and across doses
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
timeFrame: During the 7-day (Days 0-6) post-vaccination period following each vaccine dose and across doses
measure: Number of Subjects With Any Unsolicited Adverse Events (AEs) - Step 2
timeFrame: Within the 28-day (Days 0-27) and post-vaccination period
measure: Number of Subjects With Any Unsolicited Adverse Events (AEs) - Pooling Step
timeFrame: Within the 28-day (Days 0-27) post-vaccination period.
measure: Number of Subjects With Serious Adverse Events (SAEs) - Step 2
timeFrame: Up to Day 180 for the HBsAg/AS_2 Group and up to Day 330 for the Engerix-B_2 Group
measure: Number of Subjects With Serious Adverse Events (SAEs) - Pooling Step
timeFrame: Up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group
measure: Number of Subjects With Any Potential Immune-mediated Disorders (pIMDs) - Step 2
timeFrame: Up to Day 180 for the HBsAg/AS_2 Group and up to Day 330 for the Engerix-B_2 Group
measure: Number of Subjects With Any Potential Immune-mediated Disorders (pIMDs) - Pooling Step
timeFrame: Up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group
measure: Number of Subjects With Any New Medical Conditions Requiring Medical Attention (MAEs) - Step 2
timeFrame: Up to Day 180 for the HBsAg/AS_2 Group and up to Day 330 for the Engerix-B_2 Group
measure: Number of Subjects With Any New Medical Conditions Requiring Medical Attention (MAEs) - Pooling Step
timeFrame: Up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group
measure: Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 2
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 Group
measure: Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 2
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 Group
measure: Levels of Basophils in Blood Samples - Step 2
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 Group
measure: Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2
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 Group
measure: Levels of Eosinophils in Blood Samples - Step 2
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 Group
measure: Levels of White Blood Cell (WBC) in Blood Samples - Step 2
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 Group
measure: Levels of Lymphocytes in Blood Samples - Step 2
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 Group
measure: Levels of Monocytes in Blood Samples - Step 2
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 Group
measure: Levels of Neutrophils in Blood Samples - Step 2
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 Group
measure: Platelet Count in Blood Samples - Step 2
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 Group
measure: Levels of Total Bilirubin in Blood Samples - Step 2
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 Group
measure: Levels of Diastolic Blood Pressure - Step 2
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 Group
measure: Levels of Heart Rate - Step 2
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 Group
measure: Levels of Respiratory Rate - Step 2
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 Group
measure: Levels of Systolic Pressure - Step 2
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 Group
measure: -Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Immune Markers - Step 1
timeFrame: At Day 0 prior to vaccination (PRE) and Day 44 post-vaccination
measure: Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Immune Markers - Step 1
timeFrame: At Day 0 prior to vaccination (PRE), Day 44 and Day 180 post-vaccination
measure: Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)8+ T-cells Expressing at Least 2 Immune Markers - Step 1
timeFrame: At Day 0 prior to vaccination (PRE) and Day 44 post-vaccination
measure: Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)8+ T-cells Expressing at Least 2 Immune Markers - Step 1
timeFrame: At Day 0 prior to vaccination (PRE), Day 44 and Day 180 post-vaccination
measure: Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2
timeFrame: Up to 3 days post-placebo/vaccine administration.
measure: Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Pooling Step
timeFrame: Up to 3 days post-Dose 2 vaccine administration in HBsAg/AS_1+2 Group
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Burny W, Herve C, Caubet M, Yarzabal JP, Didierlaurent AM. Utility of urinary cytokine levels as predictors of the immunogenicity and reactogenicity of AS01-adjuvanted hepatitis B vaccine in healthy adults. Vaccine. 2022 Apr 26;40(19):2714-2722. doi: 10.1016/j.vaccine.2022.03.050. Epub 2022 Mar 30.
citation: Burny W, Marchant A, Herve C, Callegaro A, Caubet M, Fissette L, Gheyle L, Legrand C, Ndour C, Tavares Da Silva F, van der Most R, Willems F, Didierlaurent AM, Yarzabal J; ECR-008 study group. Inflammatory parameters associated with systemic reactogenicity following vaccination with adjuvanted hepatitis B vaccines in humans. Vaccine. 2019 Mar 28;37(14):2004-2015. doi: 10.1016/j.vaccine.2019.02.015. Epub 2019 Mar 5.