Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HBsAg formulated with different concentrations of MPL and Aluminium Salts · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | - |
| Group B | EXPERIMENTAL | - |
| Group C | EXPERIMENTAL | - |
| Group D | EXPERIMENTAL | - |
| Group E | EXPERIMENTAL | - |
| Group F | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| HBsAg formulated with different concentrations of MPL and Aluminium Salts | BIOLOGICAL | Intramuscular injection, 3 doses |
| Engerix™-B | BIOLOGICAL | Intramuscular injection, 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 |
It is an investigational recombinant hepatitis B vaccine formulation developed by GSK plc. It combines hepatitis B surface antigen (HBsAg) with different concentrations of the adjuvant components MPL and aluminium salts, and it is being studied to evaluate immune response and reactogenicity in healthy adult volunteers.
It is intended for the prevention of hepatitis B, an infectious disease of the liver. The formulation is designed to stimulate an immune response against hepatitis B surface antigen. It is being evaluated in healthy adult volunteers rather than in patients with existing infection.
GSK plc, which trades under the ticker GSK, is the developer of this hepatitis B vaccine formulation. The company sponsors the clinical program evaluating different concentrations of the MPL and aluminium salt adjuvants combined with hepatitis B surface antigen.
It is in Phase 3 development. The program includes one completed Phase 3 trial, and no trials are currently listed as active. The vaccine candidate remains investigational and is not described as approved.
The candidate has been studied in trial NCT00697970, titled Evaluation of Immunogenicity and Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine. This completed Phase 3 trial enrolled 321 healthy volunteers aged 18 years and older in Austria and used a randomized, double-blind, active-controlled design.