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Hepatitis B Vaccine Recombinant, Adjuvanted Intramuscular · 1 trial · 2 indications
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| 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 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 |
Hepatitis B Vaccine Recombinant, Adjuvanted Intramuscular is an investigational vaccine being studied for hepatitis B, including chronic hepatitis B. It is a recombinant vaccine given by intramuscular injection and includes an adjuvant. Dynavax Technologies Corporation (ticker DVAX) is developing it, and it is currently in Phase 1 clinical development.
It is being studied for hepatitis B and chronic hepatitis B. The vaccine is intended to stimulate an immune response against hepatitis B virus through recombinant antigen combined with an adjuvant, delivered by intramuscular injection. Its use remains investigational and it is not established as an approved treatment or prevention option based on the available development information.
Dynavax Technologies Corporation, which trades under the ticker DVAX, is the developer of Hepatitis B Vaccine Recombinant, Adjuvanted Intramuscular. The company is running the clinical program for this adjuvanted recombinant hepatitis B vaccine candidate.
Hepatitis B Vaccine Recombinant, Adjuvanted Intramuscular is in Phase 1 clinical development. It is an investigational vaccine and has not completed the later-stage trials typically required for approval. The Phase 1 study is currently recruiting participants.
Hepatitis B Vaccine Recombinant, Adjuvanted Intramuscular is being studied in the Phase 1 trial NCT04843852, titled TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B. The trial is recruiting in the United States, has an estimated enrollment of 10 participants, and enrolls adults 18 years and older of all sexes.
Hepatitis B Vaccine Recombinant, Adjuvanted Intramuscular is also known as Hepatitis B Vaccine Recombinant, Adjuvanted Intramuscular Solution [HEPLISAV-B]. The HEPLISAV-B name refers to the same adjuvanted recombinant hepatitis B vaccine product associated with Dynavax Technologies Corporation.