Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Hepatitis B Vaccine Recombinant, Adjuvanted Intramuscular · 1 trial · 2 indications
Number of local and systemic solicited adverse events
Number of unsolicited adverse events
Number of Medically Attended Adverse Events (MAAEs)
| Arm | Type | Description |
|---|---|---|
| Intervention | EXPERIMENTAL | HEPLISAV-B is available in pre-filled, single-dose 0.5 mL vials. Each dose contains 20 μg of HBsAg and 3,000 μg of 1018 adjuvant. HEPLISAV-B is administered as an intramuscular injection in the deltoid region. Study subjects will receive a total of 2 injections, each administered at least 4 weeks apart - the same dosing schedule recommended for hepatitis B prevention. Once enrolled, participants will have study visits on days 0 (first injection), and weeks 2, 4 (second injection), 8, and 28. They will also have phone follow ups on day 7 and week 5 (7 days after each injection) and week 56 (end of study). |
| Name | Type | Description |
|---|---|---|
| Hepatitis B Vaccine Recombinant, Adjuvanted Intramuscular Solution [HEPLISAV-B] | DRUG | one 0.5ml intramuscular injection on day 0 and week 4. |
Inclusion Criteria: In order to participate in this study, an individual must meet all the following criteria: 1. \>18 years old 2. Diagnosed with CHB infection, without HIV, hepatitis C nor hepatitis D co-infections 3. Currently receiving NUC with HBV VL \<100 IU/ml for ≥ 12 months 4. Willing and...
Top 6 of 10 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 |