title: Immunogenicity and safety of an investigational hepatitis B vaccine with a Toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared with a licensed hepatitis B vaccine in patients with chronic kidney disease and type 2 diabetes mellitus.
abstract: BACKGROUND
  Many 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.
  
  
  METHODS
  A prespecified subgroup analysis of immunogenicity was conducted in CKD participants with type 2 diabetes in the phase 3 trial.
  
  
  RESULTS
  In 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.
  
  
  CONCLUSIONS
  HBsAg-1018 induced significantly higher seroprotection than HBsAg-Eng in CKD patients with diabetes.
authors.affiliation: Dynavax Technologies Corporation, 2929 Seventh Street, Suite 100, Berkeley, CA 94710-2753, United States.
authors.forename: Julia M
authors.initials: JM
authors.lastname: Janssen
authors.affiliation: Quattro Clinical Research, Oakland, CA 94609, United States.
authors.forename: William L
authors.initials: WL
authors.lastname: Heyward
authors.affiliation: Adjuvance Technologies, Inc., New York, NY, United States.
authors.forename: J Tyler
authors.initials: JT
authors.lastname: Martin
authors.affiliation: Dynavax Technologies Corporation, 2929 Seventh Street, Suite 100, Berkeley, CA 94710-2753, United States. Electronic address: rjanssen@dynavax.com.
authors.forename: Robert S
authors.initials: RS
authors.lastname: Janssen
mesh_terms: D000276:Adjuvants, Immunologic / Q000627:therapeutic use; D000293:Adolescent; D000328:Adult; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy / Q000276:immunology*; D005260:Female; D006509:Hepatitis B / Q000517:prevention & control*; D006510:Hepatitis B Antibodies / Q000276:immunology; D006514:Hepatitis B Surface Antigens / Q000276:immunology; D017325:Hepatitis B Vaccines / Q000009:adverse effects* / Q000276:immunology* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D051436:Renal Insufficiency, Chronic / Q000188:drug therapy / Q000276:immunology*; D051217:Toll-Like Receptor 9 / Q000819:agonists*; D055815:Young Adult
chemical_list: D000276:Adjuvants, Immunologic; D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; C495371:TLR9 protein, human; D051217:Toll-Like Receptor 9
keywords: CKD; Hepatitis B vaccine; NCT00985426; Toll-like receptor 9; Type 2 diabetes