Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Engerix-B · 2 trials · 2 indications
Percentage of subjects who have a seroprotective immune response (anti-HBsAg antibody≥ 10 milli-international unit (mIU)/mL) 8 weeks after the last active dose of HEPLISAV™ compared to 8 weeks after the last active dose of Engerix-B®
Percentage of subjects who have a seroprotective immune response (anti-HBsAg ≥ 10 milli-international unit (mIU)/mL) after the final active injection in each treatment group (Week 12 for HEPLISAV™ and Week 28 for Engerix-B®)
| Arm | Type | Description |
|---|---|---|
| HEPLISAV and/or Placebo | EXPERIMENTAL | 0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) |
| Engerix-B(1) | ACTIVE_COMPARATOR | 1.0 mL Engerix-B |
| Engerix-B | ACTIVE_COMPARATOR | 1.0 mL Engerix-B |
| Name | Type | Description |
|---|---|---|
| HEPLISAV and/or Placebo | BIOLOGICAL | Intramuscular (IM) injections on Week 0 and Week 4; placebo (saline) injection at Week 24 |
| Engerix-B | BIOLOGICAL | Intramuscular (IM) injections on Week 0, Week 4 and Week 24 |
Inclusion Criteria: * be 40 - 70 years of age, inclusive * be seronegative for hepatitis B surface antigen (HBsAg), antibody against hepatitis B surface antigen (anti-HBsAg), antibody against hepatitis B core antigen (anti-HBcAg), and human immunodeficiency virus (HIV) * be in good health in the op...
Engerix-B is a hepatitis B vaccine used to prevent hepatitis B infection in healthy individuals. It is given to people aged 11 years and older, including adults aged 40 years and over, to stimulate immunity against the hepatitis B virus.
Engerix-B is developed by Dynavax Technologies Corporation, a biopharmaceutical company traded on NASDAQ under the ticker DVAX. The vaccine is used as a comparator in clinical trials evaluating other hepatitis B vaccines.
Engerix-B is an approved vaccine that has been used as an active comparator in Phase 3 clinical trials. These trials, which are completed, compared Engerix-B with investigational hepatitis B vaccines to assess their safety and efficacy.
Engerix-B was used in two completed Phase 3 trials: NCT00435812, which enrolled 2428 participants aged 11 years and older in Canada and Germany, and NCT01005407, which enrolled 2452 healthy adults aged 40 years and older in the United States and Canada.
No, Engerix-B is not the same as HEPLISAV. Engerix-B is a licensed hepatitis B vaccine used as a comparator in clinical trials, while HEPLISAV is an investigational hepatitis B vaccine being tested against Engerix-B in Phase 3 studies.