Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
1.0 cc HBVAXPRO 10mcgr/ml · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Intramuscular group | ACTIVE_COMPARATOR | These subjects will receive one intramuscular injection of 1.0cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur-MSD) with syringe and needle in the deltoid region. |
| Intradermal group (Mantoux) | EXPERIMENTAL | These subjects will receive one intradermal injection with mantoux technique in the forearm. 0.1cc of HBVAXPRO 40mcgr/ml (Sanofi Pasteur-MSD) will be injected. |
| Intradermal group (VAX-ID) A | EXPERIMENTAL | These subjects will receive one intradermal injection with the newly developed intradermal injection device VAX-ID in the forearm. 0.1cc of HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) will be injected. |
| Intradermal group (VAX-ID) B | EXPERIMENTAL | These subjects will receive two intradermal injections with two newly developed intradermal injection devices VAX-ID in both forearms each 0.1cc of HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) will be injected. |
| Name | Type | Description |
|---|---|---|
| VAX-ID | DEVICE | 0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) with each injection |
| 1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD) | DRUG | 1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD) |
| 0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) | DRUG | 0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) with each injection |
Inclusion Criteria: * healthy adults, checked anamnestically (based on medical history) at entry of the study * 18-35 years * vaccination status: fully vaccinated against hepatitis B at least 5 years ago, with proof of vaccine response (to avoid non-response among the subjects). Subjects has to ask...
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 |
1.0 cc HBVAXPRO 10mcgr/ml is a hepatitis B vaccine given as a 1.0 milliliter dose containing 10 micrograms per milliliter of antigen. It is used to prevent hepatitis B infection and was studied in a Phase 1 immunogenicity and safety trial in healthy adult volunteers.
1.0 cc HBVAXPRO 10mcgr/ml is used for hepatitis B, an infectious disease of the liver. The clinical program evaluated the vaccine for immunogenicity and safety in healthy adult volunteers aged 18 years and older. The only listed trial enrolled 48 participants in Belgium.
OraSure Technologies, Inc., which trades under the ticker OSUR, is the developer associated with 1.0 cc HBVAXPRO 10mcgr/ml. The product is also identified as 1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD), reflecting the Sanofi Pasteur MSD naming associated with this hepatitis B vaccine presentation.
1.0 cc HBVAXPRO 10mcgr/ml is in Phase 1 development. The single listed trial, NCT02186977, is a completed Phase 1 study, and no active trials are recorded. It is an investigational product in clinical development for hepatitis B.
1.0 cc HBVAXPRO 10mcgr/ml was studied in one completed Phase 1 trial, NCT02186977, titled Proof Of Concept: Immunogenicity and Safety of hepB Injection in the Dermis Using VAX-ID. That trial enrolled 48 healthy adult volunteers in Belgium, used an active-controlled, randomized design, and has completed.