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
Session: Poster Abstract Session: Vaccines: New and Novel
Thursday, October 27, 2016
Room: Poster Hall

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 (HEPLISAV-B: 4376; Engerix-B: 2289).

HEPLISAV-B

Engerix-B

Difference in SPRs

  (95% CI)*

N

Seroprotection Rate % (95% CI)

N

Seroprotection Rate % (95% CI)

Age Group

18 ‑ 29

174

100.0 (97.9 ‑ 100.0)

99

93.9 (87.3 ‑ 97.7)

6.1 (2.8 ‑ 12.6)

30 ‑ 39

632

98.9 (97.7 ‑ 99.6)

326

92.0 (88.5 ‑ 94.7)

6.9 (4.2 ‑ 10.4)

40 ‑ 49

974

97.2 (96.0 ‑ 98.2)

518

84.2 (80.7 ‑ 87.2)

13.1 (9.9 ‑ 16.6)

50 ‑ 59

1439

95.2 (94.0 ‑ 96.3)

758

79.7 (76.6 ‑ 82.5)

15.5 (12.6 ‑ 18.7)

60 - 70

1157

91.6 (89.9 ‑ 93.1)

588

72.6 (68.8 ‑ 76.2)

19.0 (15.2 ‑ 23.0)

Sex

Men

2203

94.5 (93.5 ‑ 95.4)

1150

78.8 (76.3 ‑ 81.1)

15.7 (13.2 ‑ 18.3)

Women

2173

96.4 (95.5 ‑ 97.1)

1139

83.8 (81.5 ‑ 85.9)

12.6 (10.4 ‑ 15.0)

BMI

≥30 kg/m2

2165

94.7 (93.7 ‑ 95.6)

1076

75.4 (72.7 ‑ 77.9)

19.4 (16.7 ‑ 22.2)

<30 kg/m2

2208

96.1 (95.2 ‑ 96.9)

1212

86.6 (84.5 ‑ 88.4)

9.6 (7.6 ‑ 11.7)

Diabetes Mellitus

640

 90.0 (87.4 ‑ 92.2)

321

65.1 (59.6 ‑ 70.3)

24.9 (19.3 ‑ 30.7)

Smoker

Yes

1371

95.9 (94.7 ‑ 96.9)

711

78.6 (75.4 ‑ 81.6)

17.3 (14.2 ‑ 20.6)

No

3005

95.2 (94.4 ‑ 95.9)

1578

82.4 (80.5 ‑ 84.3)

12.8 (10.8 ‑ 14.8)

*The lower limit of the 95% CI greater than 0 indicates the predefined definition of a statistically significant difference in SPRs. Week 28 assessment

Conclusion: HEPLISAV-B, administered as 2 doses over 4 weeks, induced significantly higher peak SPRs than 3 doses of Engerix-B administered over 24 weeks in all adult groups with known factors that reduce their immune response to hepatitis B vaccines as well as in adults without those factors.

Sam Jackson, MD, Kim Erby, BS, Lalith Akella, MS, William L. Heyward, MD, MPH, Randy Hyer, MD, PhD and Robert Janssen, MD, Dynavax Technologies Corporation, Berkeley, CA

Disclosures:

S. Jackson, Dynavax Technologies: Employee , Salary

K. Erby, Dynavax Technologies: Employee , Salary

L. Akella, Dynavax Technologies: Consultant , Consulting fee

W. L. Heyward, Dynavax Technologies: Consultant , Consulting fee

R. Hyer, Dynavax Technologies: Consultant , Consulting fee

R. Janssen, Dynavax Technologies: Employee , Salary

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