Study to compare the efficacy of GSK Biologicals’ adjuvants in combination with the antigen of the Hepatitis B vaccine
Trial overview
Number of Hepatitis B (HB)-specific Cluster of Differentiation 4 (CD4+) T cells .
Timeframe: At Day 44
Number of Hepatitis B (HB)-specific Cluster of Differentiation 4 (CD4+) T cells
Timeframe: At Days 0, 14, 30 and 60
Number of Hepatitis B (HB) - specific Cluster of Differentiation 8 (CD8+) T cells.
Timeframe: At Days 0, 14, 30, 44, and 60
Number of HB specific CD4+ T cells .
Timeframe: At Days 0, 180 and 360
Number of HB - specific CD8+ T cells.
Timeframe: At Days 0, 180 and 360
Number of HB - specific CD4+ T cells.
Timeframe: At Days 0, 360 and 374
Number of HB - specific CD8+ T cells
Timeframe: At Days 0, 360 and 374
Number of HB - specific CD4+ T cells
Timeframe: At Days 0, 14, 30, 33, 37, 44 and 60
Number of HB - specific CD8+ T cells
Timeframe: At Days 0, 14, 30, 44, 60 and 180
Number of Hepatitis B (HB)-specific Cluster of Differentiation 4 (CD4+) T cells expressing T helper cell type 1 response/T helper cell type 2 response (Th1/Th2) cytokine profile
Timeframe: At Days 0, 14, 30, 44 and 60
Number of HB specific Cluster of Differentiation 4 (CD4+) T cells expressing Th1/Th2 cytokine profile
Timeframe: At Days 0 and 180
Anti-Hepatitis B (anti-HB) antibody concentrations in serum, as measured by Chemi Luminescence Immuno Assay (CLIA)
Timeframe: At Days 0, 30, 44, and 60
Anti-HB antibody concentrations in serum, as measured by Chemi Luminescence Immuno Assay (CLIA)
Timeframe: At Days 0, 180 and 360
Anti-HB antibody concentrations in serum, as measured by CLIA
Timeframe: At Days 0, 374 and 390
Number of Hepatitis B (HB)-specific memory B cells
Timeframe: At Days 0, 30, 37, 44 and 60.
Number of HB-specific memory B cells
Timeframe: At Days 180 and 360
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible protein-10 and monocyte chemotactic protein-1 cytokines in serum
Timeframe: At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30,30+ (Day 30 + 3 to 6 hours), 31, 33 and 37.
Normalized levels of white blood cells (WBC) and creatine phosphokinases (CPK)
Timeframe: At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30, 30+ (Day 30 + 3 to 6 hours), 31, 33, 37 and 60.
Normalized levels of C-reactive protein (CRP)
Timeframe: At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30, 30+ (Day 30 + 3 to 6 hours), 31, 33 and 37.
Normalized levels of WBC and of CPK
Timeframe: At Days 0, 30, 37 and 60.
Normalized levels of CRP
Timeframe: At Days 0, 30 and 37.
Levels of white blood cells, neutrophils, lymphocytes, monocytes, eosinophils and basophils
Timeframe: At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30, 30+ (Day 30 + 3 to 6 hours), 31, 33, 37 and 60.
Levels of WBC, NEU, LYM, MON, EOS and BAS
Timeframe: At Days 0, 30, 37 and 60.
Normalized levels of red blood cells and platelets
Timeframe: At Days 0, 30, 37 and 60.
Normalized levels of haemoglobin, alanine aminotransferase and aspartate aminotransferase
Timeframe: At Days 0, 30, 37 and 60.
Normalized levels of serum creatinine, urea and lactate dehydrogenase
Timeframe: At Days 0, 30, 37 and 60.
Number of subjects with normal and abnormal levels of white blood cells, neutrophils, lymphocytes, monocytes, eosinophils, basophils, C-reactive protein, and creatine phosphokinase.
Timeframe: At Day 0 and up to Day 60.
Number of subjects with normal and abnormal levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK.
Timeframe: At Day 0 and up to Day 60.
Number of subjects presenting normal and abnormal levels of white blood cells, neutrophils, lymphocytes, monocytes, eosinophils, basophils, C-reactive protein, and creatine phosphokinase.
Timeframe: Post vaccination (up to Day 360)
Number of subjects having normal and abnormal levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK.
Timeframe: At Days 360 and 390.
Number of subjects with normal and abnormal levels of red blood cells, platelets, haemoglobin, alanine aminotransferase, aspartate aminotransferase, serum creatinine, urea and lactate dehydrogenase
Timeframe: At Day 0 and up to Day 60.
Number of subjects with normal and abnormal levels of RBC, PLA, HGB, ALT, AST, S-CREA, urea and LDH
Timeframe: post vaccination (up to Day 360).
Number of subjects presenting normal and abnormal levels of red blood cells, platelets, haemoglobin, alanine aminotransferase, aspartate aminotransferase, serum creatinine, urea and lactate dehydrogenase
Timeframe: At Days 360 and 390.
Number of subjects reporting any, grade 3 and related solicited local symptoms following primary vaccination.
Timeframe: Within the 14-day (Days 0-13) follow up period following primary vaccination with the GSK223192A, Fendrix™ or Engerix-B™ vaccines.
Number of subjects reporting any, grade 3 and related solicited general symptoms following primary vaccination.
Timeframe: Within the 14-day (Days 0-13) follow up period following primary vaccination with the GSK223192A, Fendrix™ or Engerix-B™ vaccine.
Number of subjects reporting any, grade 3 and related solicited local symptoms following booster vaccination.
Timeframe: Within the 7-day (Days 0-6) follow up period following booster vaccination with HBsAg antigens
Number of subjects reporting any, grade 3 and related solicited general symptoms following booster vaccination.
Timeframe: Within the 7-day (Days 0-6) follow up period following booster vaccination with HBsAg antigens
Number of subjects reporting any, Grade 3 and/or related unsolicited adverse events (AEs) following primary vaccination
Timeframe: Within the 31-day (Days 0-30) follow up period following primary vaccination with the GSK223192A, Fendrix™ or Engerix-B™ vaccine
Number of subjects reporting any, Grade 3 and/or related unsolicited adverse events (AEs) following booster vaccination
Timeframe: Within the 31-day (Days 0-30) follow up period following booster vaccination with HBsAg antigens
Number of subjects reporting any and related adverse events of specific interest (AESIs)
Timeframe: During the entire study period, from Day 0 to study end, at Day 360 for subjects not in Subsets 1 & 2 and at Day 390 for subjects in Subsets 1 & 2.
Number of subjects reporting any serious adverse events (SAEs) and SAEs related to study vaccination
Timeframe: During the entire study period, from Day 0 to study end, at Day 360 for subjects not in Subsets 1 & 2 and at Day 390 for subjects in Subsets 1 & 2.
Levels of messenger ribonucleic acid (mRNA) as measured by quantitative polymerase chain reaction (qPCR)
Timeframe: At Days 0, 1, 14, 30, 31, 33 and 37
mRNA levels as measured by qPCR
Timeframe: At Days 0, 1, 14, 30, 31, 33 and 37
mRNA levels as measured by quantitative polymerase chain reaction (qPCR)
Timeframe: At Days 0, 1, 14, 30, 31, 33 and 37
Messenger ribonucleic acid (mRNA) levels as measured by quantitative polymerase chain reaction (qPCR)
Timeframe: At Days 0, 1, 14, 30, 31, 33 and 37
Levels of mRNA as measured by qPCR
Timeframe: At Days 0, 1, 14, 30, 31, 33 and 37
Levels of messenger ribonucleic acid (mRNA) as measured by qPCR
Timeframe: At Days 0, 1, 14, 30, 31, 33 and 37
Levels of mRNA as measured by quantitative polymerase chain reaction (qPCR)
Timeframe: At Days 0, 1, 14, 30, 31, 33 and 37
Participation criteria
- All subjects must satisfy the following criteria at study entry :
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
- Previous vaccination against Hepatitis B.
- All subjects must satisfy the following criteria at study entry :
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- A male or female between, and including, 18 and 45 years at the time of the first vaccination.
- Written informed consent obtained from the subject.
- Healthy subjects as established by medical history, clinical examination and clinical laboratory assessment before entering into the study.
- If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
- The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
- Previous vaccination against Hepatitis B.
- Positive for anti-HBs antibodies, antiHBc antibodies, HBsAg, HCV antibodies and/or HIV.
- Any previous administration of specific adjuvant components.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period or participation to another pharmaceutical/vaccine study.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine with the exception of the influenza vaccine (pandemic or seasonal) which can be administered > 21 days preceding or > 21 days following each primary vaccine dose (Doses 1 and 2) AND > 7 days preceding or > 7 days following the booster dose.
- Administration of immunoglobulins and/or any blood products within the last 3 months.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
- Current serious neurologic or mental disease.
- Any past or current malignancies and lymphoproliferative disorders.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, renal functional abnormality, autoimmune disease or anemia, as determined by physical examination or laboratory screening tests at the discretion of the investigator.
- Acute disease at the time of enrolment.
- Pregnant or lactating female.
- History of chronic alcohol consumption and/or drug abuse.
- Other conditions that the principal investigator judges may interfere with study findings.
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.