Oct 27, 2016 - Results. The table. Q208 presents peak SPRs in the per-protocol population (HEPLISAV-. B: 4376; Engerix-B: 2289). HEPLISAV-B. Engerix-B.
754. Immunogenicity of Investigational 2-Dose Hepatitis B Vaccine, HEPLISAV-B, Compared With a Licensed Vaccine (ENGERIX-B) in Adults With Factors That Reduce Immune Responses Sam Jackson, MD; Kim Erby, BS; Lalith Akella, MS; William L. Heyward, MD, MPH; Randy Hyer, MD, PhD; Robert Janssen, MD; Dynavax Technologies Corporation, Berkeley, California Session: 76. Vaccines: New and Novel Thursday, October 27, 2016: 12:30 PM
Q208
Background. Adults who are older, male, have a high BMI, diabetes mellitus, or are smokers have reduced seroprotection rates (SPRs) (% with anti-HBs ≥10 mIU/mL) with currently licensed hepatitis B vaccines. A previously reported randomized, observer-blind, multicenter, phase 3 study was conducted among 8374 adults 18–70 years of age comparing 2 doses of HEPLISAV-B (20 mcg rHBsAg + 3000 mcg 1018 adjuvant, a Toll-like receptor 9 agonist) at 0 and 4 weeks to 3 doses of Engerix-B at 0, 4 and 24 weeks. The peak SPR in the HEPLISAV-B group at Week 24 was 95.4% and in the Engerix-B group at Week 28 was 81.3%. Further analyses are presented here. Methods. Primary and secondary objectives were to compare peak SPRs in subpopulations by age, sex, BMI, diabetes mellitus status, and smoking status. Results. The table presents peak SPRs in the per-protocol population (HEPLISAVB: 4376; Engerix-B: 2289).
HEPLISAV-B
N Age Group 18–29 30–39 40–49
Seroprotection Rate % (95% CI)
174 100.0 (97.9–100.0) 632 98.9 (97.7–99.6) 974 97.2 (96.0–98.2)
Engerix-B
N
Seroprotection Difference in Rate % (95% CI) SPRs (95% CI)*
99 93.9 (87.3–97.7) 6.1 (2.8–12.6) 326 92.0 (88.5–94.7) 6.9 (4.2–10.4) 518 84.2 (80.7–87.2) 13.1 (9.9–16.6)
continued. HEPLISAV-B
50–59 60–70 Sex Men Women BMI ≥30 kg/m2
