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...
Hepatitis E vaccine, recombinant is used for the prevention of hepatitis, specifically hepatitis E virus infection. It is an investigational vaccine being developed by GSK plc (GSK) for use in adults. The vaccine is designed to elicit an immune response against the hepatitis E virus to protect against infection.
Hepatitis E vaccine, recombinant is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. GSK is conducting clinical trials to evaluate the safety and efficacy of this investigational vaccine for the prevention of hepatitis.
Hepatitis E vaccine, recombinant is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The vaccine is being studied in a completed Phase 2 trial to assess its safety and efficacy in preventing hepatitis.
Hepatitis E vaccine, recombinant has been studied in one clinical trial, NCT00287469, titled 'A Safety and Efficacy Study of the Hepatitis E Vaccine in Nepal.' This Phase 2, randomized, double-blind, placebo-controlled trial enrolled 2,000 healthy adult volunteers in Nepal and has been completed.
No, Hepatitis E vaccine, recombinant is not a monoclonal antibody. It is classified as a recombinant vaccine, which means it is produced using recombinant DNA technology to generate antigens that stimulate an immune response against the hepatitis E virus.