Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HEPLISAV · 4 trials · 3 indications
The percentage of participants with Medically-attended adverse events (MAEs), Serious Adverse Events (SAEs), and immune-mediated Adverse Events of Special Interest (AESIs). MAEs are Adverse events (AEs) for which a subject sought medical attention at a doctor's office, clinic or study site, or emergency room, or was hospitalized. SAEs are AEs that met the definition of Serious per FDA regulations. Immune-mediated AESIs are AEs that were confirmed to be autoimmune in etiology.
Percentage of subjects with type 2 diabetes mellitus who have a seroprotective immune response (anti-HBs ≥ 10 milli-international unit (mIU)/mL) who receive HEPLISAV compared with subjects who receive Engerix-B
Local and Systemic post-injection reactions.
| Arm | Type | Description |
|---|---|---|
| HEPLISAV | EXPERIMENTAL | 0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) administered intramuscularly in the deltoid muscle at Weeks 0, 4, and placebo (saline injection) at Week 24, followed by a 52-week safety follow-up from the last active dose of HEPLISAV. |
| Engerix-B | ACTIVE_COMPARATOR | 1.0 mL Engerix-B (20 mcg HBsAg adsorbed on 500 mcg of aluminum hydroxide) administered intramuscularly in the deltoid muscle at Weeks 0, 4, and 24, followed by a 32-week safety follow-up from the last dose of Engerix-B. |
| Fendrix | ACTIVE_COMPARATOR | 0.5 mL Fendrix |
| Name | Type | Description |
|---|---|---|
| HEPLISAV | BIOLOGICAL | Intramuscular injections at Week 0 and Week 4, plus a placebo injection at Week 24 |
| Engerix-B | BIOLOGICAL | Intramuscular injections at Week 0, Week 4, and Week 24 |
| Fendrix | BIOLOGICAL | Intramuscular (IM) injection on Day 1 |
A subject must meet all of the following criteria to be eligible for the trial: Inclusion Criteria: * Be 18-70 years of age, inclusive * Able to comprehend and follow all required study procedures and be available for all visits scheduled in the study * If a woman is of childbearing potential, she...
HEPLISAV is a hepatitis B vaccine being developed for the prevention of hepatitis B infection. It is studied in healthy adults, including older adults, and in adults with end stage renal disease who are on hemodialysis. The vaccine is designed to generate an immune response against the hepatitis B virus.
HEPLISAV is being developed by Dynavax Technologies Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol DVAX. Dynavax is conducting clinical trials to evaluate the safety and immunogenicity of the vaccine across different patient populations.
HEPLISAV is in Phase 3 clinical development. The most advanced trial, NCT02117934, is a Phase 3 study comparing HEPLISAV to Engerix-B vaccine in healthy adults. Earlier Phase 2 and Phase 1 studies have also been completed, but the drug remains investigational and is not yet approved.
HEPLISAV has been studied in several completed clinical trials. NCT02117934 is a Phase 3 trial in 8,374 healthy adults comparing HEPLISAV to Engerix-B. NCT01195246 is a Phase 3 trial in 155 adults on hemodialysis with end stage renal disease. NCT00511095 is a Phase 2 trial in 207 healthy adolescents, and NCT01999699 is a Phase 1 trial in 25 healthy older adults.
HEPLISAV is a vaccine designed to stimulate the immune system to produce antibodies against the hepatitis B virus. It is administered to induce protective immunity, particularly in populations at risk of hepatitis B infection, such as healthy adults and those with end stage renal disease undergoing hemodialysis.
HEPLISAV is not the same as Engerix-B. Engerix-B is a comparator vaccine used in clinical trials to evaluate HEPLISAV's safety and immunogenicity. In the Phase 3 trial NCT02117934, HEPLISAV was directly compared to Engerix-B in healthy adults to assess immune responses.