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Also known as Engerix-B vaccine, EngerixTM-B
Engerix-B · 6 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 |
|---|---|---|
| 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: * Between 18 and 40 years old. * Written informed consent will have been obtained from the subjects. * Good physical condition as established by physical examination and history taking at the time of entry. * Female participants will avoid becoming pregnant during the study peri...
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 |
Engerix-B is a hepatitis B vaccine used to prevent hepatitis B infection. It is developed by GSK plc and studied in healthy adult volunteers across multiple countries including Belgium, Germany, Austria, Denmark, and Iceland. Clinical trials have evaluated its immunogenicity, safety, and reactogenicity in adults, including older adults aged 50 years and above.
Engerix-B is made by GSK plc, which trades under the ticker GSK. GSK is the developer of the vaccine and has sponsored the clinical trials evaluating its use in hepatitis B prevention.
Engerix-B has been studied in Phase 3 clinical trials. The Phase 3 trials include NCT00697840 and NCT00697242, both of which are completed. The vaccine has also been evaluated in Phase 2 trials such as NCT00805389 and NCT00697853.
Engerix-B has been evaluated in six completed clinical trials, including NCT00805389, NCT00697853, NCT00697840, and NCT00697242. These trials enrolled a total of 1,584 participants and assessed immunogenicity, safety, and reactogenicity in healthy adults, with some trials including older adults aged 50 and above.
Yes, Engerix-B is also known as Engerix-B vaccine, Engerix B, and Engerix-B. These names refer to the same hepatitis B vaccine developed by GSK plc. The alternative names include variations with trademark symbols such as Engerix™-B and Engerix-B™.