Vaccine Info

Heplisav-B Hepatitis B Vaccine

Description

Heplisav-B combines hepatitis B surface antigen with Dynavax's proprietary Toll-like Receptor (TLR), 9 agonist, to enhance the immune response.

Indication

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.

Dosage

Heplisav-B is administered by intramuscular injection in the deltoid region.  

It is a two-dose series given one month apart.  

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
Updated
September 30th, 2019