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Kidney Week

Abstract: FR-PO770

Immunogenicity and Safety of a Single Booster Dose of Heplisav-B in Patients Undergoing Hemodialysis

Session Information

Category: Dialysis

  • 701 Dialysis: Hemodialysis and Frequent Dialysis

Authors

  • Hyer, Randall N., Dynavax Technologies, Berkeley, California, United States
  • Janssen, Robert, Dynavax Technologies, Berkeley, California, United States
Background

Patients with end-stage renal disease (ESRD) undergoing hemodialysis have a greater risk of hepatitis B virus (HBV) exposure, a lower seroprotection response to primary HBV vaccination, and experience a more rapid decline in antibody to HBV surface antigen (anti-HBs) levels compared with healthy subjects. Anti-HBs levels should be assessed annually, and a booster provided if levels decline to <10 mIU/mL. Heplisav-B® is a TLR9-agonist-adjuvanted HBV vaccine with higher protection rates than commonly used alum-adjuvanted HBV vaccine (Engerix-B®), particularly in populations known to be hyporesponsive. This phase 3, randomized, open-label study assessed the immunogenicity of a single booster dose of Heplisav-B in patients with ESRD receiving hemodialysis who had previously received HBV vaccinations.

Methods

Adult patients with or without seroprotection from at least 1 HBV vaccine series (prior responders and prior nonresponders, respectively) and with anti-HBs levels <10 mIU/mL were randomized 1:1:1 to receive a booster vaccination of Heplisav-B, Engerix-B, or Fendrix (not available in the US). Seroprotection rates (SPRs) (proportion of patients with anti-HBs ≥10 mIU/mL) were assessed at week 4. Here we report the comparison between Heplisav-B and Engerix-B.

Results

A total of 76 prior nonresponders (Heplisav-B, n=38; Engerix-B, n=38) and 28 prior responders (Heplisav-B, n=16; Engerix-B, n=12) were enrolled. Among prior nonresponders, a single dose of Heplisav-B induced a higher SPR at week 4 compared with a double dose of Engerix-B (42.1% vs 18.9%); treatment difference was 23.2% (95% CI: 1.4, 43.1). Among prior responders, SPRs at week 4 were comparable (Heplisav-B: 80.0% vs Engerix-B: 90.9%; treatment difference: –10.9% [95% CI: –41.3, 23.5]). In a post hoc analysis based on criteria established in prior phase 3 trials, the SPR at week 4 with Heplisav-B group was significantly higher than with Engerix-B among prior nonresponders. Adverse events (AEs), serious AEs, and deaths were comparable between groups.

Conclusion

A single booster of Heplisav-B provides better protection against HBV than a double dose of Engerix-B with a comparable safety profile in patients undergoing hemodialysis who were nonresponders to prior HBV vaccination.
Acknowledgement: Writing assistance, funded by Dynavax Technologies, provided by Caroline Walsh Cazares, PhD, of JB Ashtin.

Funding

  • Commercial Support