Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Hepatitis E vaccine, recombinant · 1 trial · 1 indication
Percent of participants of definite hepatitis E by category and immunological markers (anti HEV) during the follow-up period. * Illness for at least 3 days comprised of at least 3 of the following symptoms: fatigue, loss of appetite, abdominal discomfort, right upper quadrant pain, nausea, vomiting * Peak of Alanine Aminotransferase (ALT) greater then 2.5 times the upper limit of normal (2.5 x 42 =105) * Percent of Participants = n x 100 / N
| Arm | Type | Description |
|---|---|---|
| 20mcg Recombinant HEV | EXPERIMENTAL | 20mcg of recombinant HEV antigen administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule |
| Placebo | PLACEBO_COMPARATOR | PBS buffer placebo containing alum was administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule. |
| Name | Type | Description |
|---|---|---|
| Hepatitis E vaccine, recombinant (Sar 56 kDa) | BIOLOGICAL | 20mcg or rhE Sar 56 kDa/dose of 0.5 mL, aluminium hydroxide (0.5 mg/dose) and phenoxyethanol (2.5 mg/dose) |
| Placebo | OTHER | PBS buffer placebo containing alum |
Inclusion Criteria: * A male or female 18 years of age or older at the time of the first vaccination. * Written or oral witnessed (if the subject was illiterate) informed consent obtained from the subject * Free of obvious health problems as established by medical history before entering into the s...
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 | 5 | PHASE2 | Daplusiran/Tomligisiran, Bepirovirsen |
| Aligos Therapeutics, Inc. | ALGS | 1 | PHASE2 | ALG-000184 |
| Precision BioSciences, Inc. | DTIL | 2 | PHASE1 | PBGENE-HBV |
The Hepatitis E vaccine, recombinant is a preventive vaccine being developed for hepatitis E, a liver infection caused by the hepatitis E virus. It is designed to protect healthy adults from infection. It is an investigational product in Phase 2 development and is not approved for use.
The Hepatitis E vaccine, recombinant is being developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program for this vaccine candidate.
The Hepatitis E vaccine, recombinant is in Phase 2 clinical development. It has completed one Phase 2 trial and has no active trials at this time. It is investigational and has not been approved by the FDA or any other regulatory agency.
The Hepatitis E vaccine, recombinant has been studied in one completed Phase 2 trial, NCT00287469, titled A Safety and Efficacy Study of the Hepatitis E Vaccine in Nepal. That randomized, double-blind, placebo-controlled trial enrolled 2,000 healthy adult volunteers in Nepal.
Yes. The Hepatitis E vaccine, recombinant is also known as Hepatitis E vaccine, recombinant (Sar 56 kDa). Sar 56 kDa refers to the same recombinant vaccine candidate developed by GSK plc for the prevention of hepatitis E.