• Julia M Janssen, William L Heyward, J Tyler Martin, and Robert S Janssen.
• Dynavax Technologies Corporation, 2929 Seventh Street, Suite 100, Berkeley, CA 94710-2753, United States.
• Vaccine. 2015 Feb 11;33(7):833-7.

BackgroundMany patients with chronic kidney disease (CKD) are hyporesponsive to currently licensed alum-adjuvanted hepatitis B vaccines, including Engerix-B(®) (HBsAg-Eng). Seroprotection rates (SPRs) are further reduced in CKD patients with diabetes mellitus. Three doses of an investigational hepatitis B vaccine (HBsAg-1018) that uses a Toll-like receptor 9 agonist demonstrated superior SPRs to 4 double doses of HBsAg-Eng in a large phase 3 trial of CKD patients.MethodsA prespecified subgroup analysis of immunogenicity was conducted in CKD participants with type 2 diabetes in the phase 3 trial.ResultsIn 328 participants, the peak SPR in the HBsAg-1018 group met criteria for noninferiority and superiority to the peak SPR in the HBsAg-Eng group. The peak geometric mean concentration of antibody against hepatitis B surface antigen in the HBsAg-1018 group was statistically significantly higher than in the HBsAg-Eng group.ConclusionHBsAg-1018 induced significantly higher seroprotection than HBsAg-Eng in CKD patients with diabetes.Copyright © 2015 Elsevier Ltd. All rights reserved.

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