Heplisav-B is indicated for the prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older.
Hepatitis B has a long incubation period.
Heplisav-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.
Clinical Trials NCT03934736: Phase 1 Clinical Trial Heplisav-B in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis
Primary Outcome Measures:
1. Safety evaluation of clinically significant adverse events (Time Frame: Monitor for safety until Week 68 or EOS)
- To evaluate the rate of medically-attended adverse events (MAEs), serious adverse events (SAEs), and immune-mediated adverse events of special interest (AESIs).
2. Evaluation of seroprotection rate (SPR) (Time Frame: Week 20)
- To evaluate the immunogenicity induced by HEPLISAV-B® when administered according to the proposed dosing schedule, as measured by the SPR, defined as antibody to hepatitis B surface antigen (anti-HBs) ≥ 10 mIU/mL
Secondary Outcome Measures:
1. Evaluation of immunogenicity [ Time Frame: Weeks 4, 8, 16, 20, 24, 28, 52, 68 ]
- To evaluate the immunogenicity induced by HEPLISAV-B® as measured by the serum anti-HBs geometric mean concentration (GMC) on hemodialysis