Peak Immunogenicity of Two Doses of Investigational HEPLISAV-B™ in Difficult to Vaccinate Individuals: Seroprotection Rates in Three Phase 3 Trials
AASLD LiverLearning®. Jackson S. Nov 14, 2016; 144672
Sam Jackson
Sam Jackson
Login now to access Regular content available to all registered users.

AASLD Members enjoy free LiverLearning® Premium Access. Registrants of The Liver Meeting® receive LiverLearning® Premium Access for one year from the first day of the meeting. A LiverLearning® Subscription ($150.00 US) grants access to LiverLearning® Premium content for one year after date of purchase. Click here to purchase your Premium Access Subscription now.


Abstract
Discussion Forum (0)
Rate & Comment (0)
ABSTRACT FINAL ID: 1780

TITLE: Peak Immunogenicity of Two Doses of Investigational HEPLISAV-B™ in Difficult to Vaccinate Individuals: Seroprotection Rates in Three Phase 3 Trials

SPONSORSHIP - THIS STUDY WAS SPONSORED BY: (IF THIS ABSTRACT WAS NOT SPONSORED PLEASE INDICATE):
Dynavax

ABSTRACT BODY:
Background: Improved HBV vaccine immunogenicity is needed for certain populations who have reduced seroprotection rates with traditional vaccines. Three multi-center, observer-blinded, randomized, phase 3 studies, compared two doses of HEPLISAV-B (H) to three doses of Engerix-B® (E).
Methods: H (20 mcg rHBsAg combined with 3000 mcg 1018, a Toll-like receptor 9 agonist) was administered at 0 and 4 weeks, with placebo administered at 24 weeks. E (20 mcg rHBsAg) was administered at 0, 4 and 24 weeks. Peak seroprotection rates (SPR=proportion with anti-HBs ≥ 10 mIU/mL) were compared in analyses pooling the modified intent-to-treat (mITT) populations of the 3 trials.
Results: The 12,728 subjects in the mITT population had the following baseline characteristics that were well balanced across treatment groups: mean age 49.3 years, 49.0% men; 43.4% BMI ≥ 30 kg/m2; 78.0% white; 18.9% black; 30.7% smokers; 10.6% with diabetes mellitus; and 1.2% with chronic liver disease (hepatic steatosis 60.1%; HCV 27.4%, other 12.5%). The peak SPRs of H were statistically significantly higher (p value<0.01) than E when stratified according to factors that have previously been associated with reduced seroprotection rates (Table 1). Both vaccines were generally well-tolerated with the rate and severity of AEs being similar across the groups.
Conclusion: HEPLISAV-B given as 2 doses over 4 weeks induced significantly higher rates of seroprotection than Engerix-B given as 3 doses over 24 weeks in groups known to have reduced seroprotection rates as well as in groups known to have good responses to currently licensed hepatitis B vaccines.
Code of conduct/disclaimer available in General Terms & Conditions