Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HBV-MPL vaccine Formulation A · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | HBV-MPL Formulation A at months 0 and 6 |
| Group B | EXPERIMENTAL | HBV-MPL Formulation B at months 0 and 6 |
| Group C | EXPERIMENTAL | HBV-MPL Formulation A at month 0 and Engerix™-B at month 6 |
| Group D | ACTIVE_COMPARATOR | Engerix™-B at months 0, 1, 6 |
| Name | Type | Description |
|---|---|---|
| HBV-MPL vaccine Formulation A | BIOLOGICAL | Single dose (when extemporaneously co-administered with Engerix™-B) or 2-dose (when administered alone) intramuscular injection |
| HBV-MPL vaccine Formulation B | BIOLOGICAL | 2-dose intramuscular injection |
| Engerix™-B | BIOLOGICAL | Single dose (when extemporaneously co-administered with HBV-MPL) or 3-dose (when administered alone) intramuscular injection |
Inclusion Criteria: * Age: between 11 and 15 years at the time of the first vaccination. * Free of obvious health problems as established by medical history and clinical examination before entering into the study. * Written informed consent obtained from the parents or guardians of the subject and ...
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 |
HBV-MPL vaccine Formulation A is an investigational vaccine developed by GSK plc for the prevention of hepatitis B. It is a Phase 2 candidate that combines hepatitis B vaccine antigens with an MPL adjuvant component. It has been studied in healthy adolescents rather than in people already infected with hepatitis B.
HBV-MPL vaccine Formulation A is being developed for hepatitis B, an infectious disease of the liver. The clinical program evaluated it in healthy adolescents as a preventive vaccine, with immunogenicity and safety as the main measures. It is not an approved product and remains in clinical development.
GSK plc, which trades under the ticker GSK, is the developer of HBV-MPL vaccine Formulation A. The Phase 2 study was run under GSK Bio, the company's biologicals unit, and compared the candidate vaccines against Engerix-B, GSK's licensed hepatitis B vaccine.
HBV-MPL vaccine Formulation A is in Phase 2 development. The only recorded trial, NCT00697775, is a completed Phase 2 study, and no trials for this formulation are currently active. It is an investigational vaccine and has not been approved by the FDA.
HBV-MPL vaccine Formulation A has been studied in one clinical trial, NCT00697775, titled Safety and Immunogenicity of GSK Bio's Candidate HBV-MPL Vaccines Compared to Engerix-B, in Healthy Adolescents. The completed Phase 2 trial enrolled 200 participants in Germany, was randomized and active-controlled, and included adolescents aged 11 years and older.