Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HEPLISAV · 4 trials · 2 indications
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®)
Local and Systemic post-injection reactions.
| Arm | Type | Description |
|---|---|---|
| HEPLISAV | EXPERIMENTAL | 0.5 mL HEPLISAV |
| Engerix-B | ACTIVE_COMPARATOR | 2.0 mL Engerix-B |
| Fendrix | ACTIVE_COMPARATOR | 0.5 mL Fendrix |
| HEPLISAV and/or Placebo | EXPERIMENTAL | 0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) |
| Name | Type | Description |
|---|---|---|
| HEPLISAV | BIOLOGICAL | Intramuscular (IM) injection on Day1 |
| Engerix-B | BIOLOGICAL | Intramuscular (IM) injection on Day 1 |
| Fendrix | BIOLOGICAL | Intramuscular (IM) injection on Day 1 |
| HEPLISAV and/or Placebo | BIOLOGICAL | Intramuscular (IM) injections on Week 0, Week 4; placebo (saline) injection at Week 24 |
Inclusion Criteria: * ≥ 18 years of age * Has loss of renal function and is receiving hemodialysis treatments * Is not seroprotected against hepatitis B (has anti-HBs \< 10 mIU/mL) * In the opinion of the investigator, is clinically stable * Be serum negative for HBsAg, anti-hepatitis B core antige...
HEPLISAV is a hepatitis B vaccine studied for the prevention of hepatitis B virus infection. It has also been evaluated in adults with end stage renal disease, including patients on hemodialysis, who often respond poorly to conventional hepatitis B vaccines. Its clinical program covers both healthy adult and older adult populations.
HEPLISAV is developed by Dynavax Technologies Corporation, which trades on the Nasdaq under the ticker DVAX. The company sponsored the clinical trials of the vaccine, including the Phase 3 study comparing it with Engerix-B and the Phase 3 study in adults on hemodialysis.
HEPLISAV has been studied in Phase 3 clinical development. Its Phase 3 program includes NCT00435812, which enrolled 2,428 participants with hepatitis B, and NCT01195246, which enrolled 155 adults with end stage renal disease on hemodialysis. Earlier Phase 1 and Phase 2 studies were also completed.
Four completed trials are registered for HEPLISAV: NCT01999699, a Phase 1 study in healthy older adults; NCT01195246, a Phase 3 study in adults on hemodialysis with end stage renal disease; NCT00511095, a Phase 2 open-label study; and NCT00435812, a Phase 3 active-controlled study versus Engerix-B.
Across the registered studies, 2,815 participants were enrolled. The largest was NCT00435812, a randomized, double-blind, active-controlled Phase 3 trial with 2,428 participants in Canada and Germany. The hemodialysis study NCT01195246 enrolled 155 adults, and the Phase 2 study NCT00511095 enrolled 207.
Yes. HEPLISAV was evaluated in adults with end stage renal disease in the Phase 3 trial NCT01195246, titled a study of safety and immunogenicity of HEPLISAV in adults on hemodialysis. That trial enrolled 155 participants in Germany and has been completed. The other registered studies focused on hepatitis B in healthy volunteers.