Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Engerix-B
Hepatitis B adjuvanted vaccine · 9 trials · 1 indication
The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD40L), Interleukin (IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs). Results for the Day 44 time point are the primary results among the outcome measure results presented.
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | - |
| Group B | ACTIVE_COMPARATOR | - |
| Group C | EXPERIMENTAL | - |
| Group D | ACTIVE_COMPARATOR | - |
| Group E | EXPERIMENTAL | - |
| GSK223192A 1 Group | EXPERIMENTAL | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| GSK223192A 2 Group | EXPERIMENTAL | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| GSK223192A 3 Group | EXPERIMENTAL | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| Fendrix Group | EXPERIMENTAL | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| Engerix-B Group | ACTIVE_COMPARATOR | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| Group F | EXPERIMENTAL | Subjects will receive HBV-MPL vaccine in the primary schedule 0, 6 months and will receive a booster dose of Engerix™-B vaccine at 70 months |
| Group G | EXPERIMENTAL | Subjects will receive Engerix™-B vaccine in the primary schedule 0, 6 months and will receive a booster dose of HBV-MPL vaccine at 70 months |
| Group H | EXPERIMENTAL | Subjects will receive Engerix™-B vaccine in the primary schedule 0, 6 months and will receive a booster dose of Engerix™-B vaccine at 70 months |
| Name | Type | Description |
|---|---|---|
| Hepatitis B adjuvanted vaccine | BIOLOGICAL | - |
| Engerix-B | BIOLOGICAL | - |
| Engerix™-B | BIOLOGICAL | Intramuscular injection, 2 doses |
| HBV-MPL 208129 | BIOLOGICAL | Intramuscular injection, 2 doses |
| Vaccine containing HBsAg absorbed on aluminium salts - experimental formulation | BIOLOGICAL | Intramuscular injection, 2 doses; experimental formulation |
| Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL | BIOLOGICAL | Intramuscular injection, 3 doses |
| Engerix-B™ | BIOLOGICAL | 2 doses intramuscular injections |
| Fendrix™ | BIOLOGICAL | 2 doses intramuscular injections |
| GSK Biologicals' Hepatitis B vaccines (GSK223192A) | BIOLOGICAL | 2 doses intramuscular injections 3 different formulations of (GSK223192A), each administered to 1 group |
| HBsAg (Booster injection) | BIOLOGICAL | Single dose intramuscular injection |
| HBV-MPL vaccine 208129 | BIOLOGICAL | 2-dose intramuscular injection |
| HBV-MPL vaccine (208129) | BIOLOGICAL | - |
| Hepatitis B vaccine, experimental formulation | BIOLOGICAL | Intramuscular injection, 3 doses |
| HBV-MPL vaccine | BIOLOGICAL | Intramuscular injection, 1 or 3 doses |
Inclusion Criteria: * Subjects were to have completed primary vaccination course. A male or female \> = 15 years of age at the time of the first vaccination. * Written informed consent obtained from the subject/ from the parents or guardians of the subject. * If the subject was a female, she was of...
Top 6 of 8 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Gilead Sciences, Inc. | GILD | 3 | PHASE3 | Viread, Tenofovir alafenamide |
| Vir Biotechnology, Inc. | VIR | 6 | PHASE3 | Tobevibart, Elebsiran |
| Bausch Health Companies Inc. | BHC | 1 | PHASE3 | Larsucosterol |
| GSK plc Sponsored ADR | GSK | 4 | PHASE2 | Daplusiran/Tomligisiran, Bepirovirsen |
| Aligos Therapeutics, Inc. | ALGS | 1 | PHASE2 | ALG-000184 |
| Precision BioSciences, Inc. | DTIL | 2 | PHASE1 | PBGENE-HBV |
The Hepatitis B adjuvanted vaccine is being developed for the prevention of Hepatitis B, an infectious disease. It is specifically studied in pre-dialysis and haemodialysis patients aged 15 years and older, a population that often responds poorly to standard Hepatitis B vaccines. It is an investigational vaccine and has not been approved.
The Hepatitis B adjuvanted vaccine is being developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program evaluating this adjuvanted vaccine in patients with kidney disease undergoing pre-dialysis or haemodialysis.
The Hepatitis B adjuvanted vaccine is in Phase 3 clinical development. Three Phase 3 trials have been completed, and no trials are currently active. The vaccine remains investigational and has not been approved by the FDA or any regulatory agency.
The Hepatitis B adjuvanted vaccine has been evaluated in three completed Phase 3 trials: NCT00383591 with 120 participants, NCT00383383 with 141 participants, and NCT00383227 with 165 participants. All three trials enrolled pre-dialysis and haemodialysis patients aged 15 years and older and compared the adjuvanted vaccine to a double dose of Engerix-B.
The Hepatitis B adjuvanted vaccine combines a Hepatitis B antigen with an adjuvant to enhance the immune response. The adjuvant is intended to improve immunogenicity, particularly in pre-dialysis and haemodialysis patients who typically have weaker responses to standard Hepatitis B vaccines. The vaccine is designed to prevent Hepatitis B infection in this patient population.