575. Immunogenicity and Safety of Investigational HEPLISAVTM Compared with Licensed Hepatitis B Vaccine (Engerix-B) in Patients with Chronic Kidney Disease (CKD) and Type 2 Diabetes Mellitus
Session: Oral Abstract Session: Immunization of Children and Adults with Immune Deficiencies
Thursday, October 3, 2013: 3:15 PM
Room: The Moscone Center: 250-262
Background: Chronic kidney disease (CKD) is associated with reduced responsiveness to hepatitis B vaccines and diabetes is associated with a further reduction in the response.

Methods: A prespecified subgroup analysis was conducted on subjects with type 2 diabetes mellitus in a randomized, controlled, phase 3 trial that was conducted among 521 patients 18-75 years of age with CKD (glomerular filtration rate ≤ 45mL/min/1.73 m2), comparing 3 single doses of an investigational hepatitis B vaccine, HEPLISAV, (20 mcg rHBsAg + 3000 mcg 1018 ISS, a toll-like receptor 9 agonist) given at 0, 4, and 24 weeks to 4 double-doses of Engerix-B (4x40 mcg rHBsAg + 500 mcg alum) given at 0, 4, 8, and 24 weeks (total of 8 injections).

Results: Among 507 subjects in the modified intent-to-treat population, 168 subjects with type 2 diabetes received HEPLISAV and 160 received Engerix-B. The mean age of subjects was 62.6 years; 61% of subjects were men; 78% were white and 18% were black. At Week 28, the peak seroprotection rate (SPR; % with anti-HBs ≥ 10 mIU/mL) in the HEPLISAV group (89.5%) was significantly higher than in the Engerix-B group (76.7%) with a difference in SPRs of 12.9% (95% CI 4.4%, 21.2%).  At week 28, the geometric mean concentration (GMC) of anti-HBs in the HEPLISAV group (448.2 mIU/mL) was significantly higher than in the Engerix-B group (109.3 mIU/mL) with a ratio of GMCs of 4.1 (95% CI 2.0, 8.6). Local post-injection reactions were less frequent in the HEPLISAV group and systemic post-injection reactions were a similar frequency in both groups. The rates of adverse events, serious adverse events, autoimmune adverse events, and deaths were similar in the two groups.

Conclusion: Three doses of HEPLISAV induced significantly higher seroprotection and antibody concentrations than 4 double doses of Engerix-B in this highly immunocompromised population. HEPLISAV was generally well tolerated among CKD patients with type 2 diabetes and had a similar safety profile to Engerix-B.

Robert Janssen, MD, Hamid Namini, PhD, William L. Heyward, MD and JT Martin, MD, Dynavax Technologies Corporation, Berkeley, CA

Disclosures:

R. Janssen, Dynavax Technologies Corporation: Employee, Salary

H. Namini, Dynavax Technologies Corporation: Employee, Salary

W. L. Heyward, Dynavax Technologies Corporation: Employee, Salary

J. Martin, Dynavax Technologies Corporation: Employee, Salary

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