Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Recombinant MPL- adjuvanted hepatitis B vaccine · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | - |
| Group B | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Recombinant MPL- adjuvanted hepatitis B vaccine | BIOLOGICAL | Intramuscular injection, 3 doses |
| Engerix™-B | BIOLOGICAL | Intramuscular injection, 3 doses |
Inclusion Criteria: * Age: older than 18 years of age. * Documented non-responders 2 to 5 months after having received 4 doses of a hepatitis B vaccine * Good physical condition as established by clinical examination and history taking at the time of entry. * Female participants who are at risk to ...
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 vaccine developed by GSK plc for hepatitis B, a viral infection of the liver. The vaccine combines a recombinant hepatitis B antigen with an MPL adjuvant, a component intended to strengthen the immune response. It is in Phase 3 clinical development.
It is being developed for hepatitis B, including use in adult non-responders, people who did not develop adequate protection after standard hepatitis B vaccination. The Phase 3 trial enrolled healthy adult volunteers aged 18 years and older in Belgium.
GSK plc, which trades under the ticker GSK, is the developer of the Recombinant MPL-adjuvanted hepatitis B vaccine. The company sponsored the Phase 3 trial evaluating the vaccine in adult non-responders.
The Recombinant MPL-adjuvanted hepatitis B vaccine is in Phase 3 development. It is investigational and has not been approved. One Phase 3 trial has been completed, and no trials are currently active.
The vaccine has been studied in one completed Phase 3 trial, NCT00697931, titled Immunogenicity and Reactogenicity of MPL Adjuvanted Recombinant Hepatitis B Vaccine and Engerix-B in Adult Non-Responders. It enrolled 116 participants in Belgium, was randomized and active-controlled, and compared the vaccine with Engerix-B.