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Vaccine. 2015 Feb 11;33(7):833-7. doi: 10.1016/j.vaccine.2014.12.060. Epub 2015 Jan 6.

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.

Author information

1
Dynavax Technologies Corporation, 2929 Seventh Street, Suite 100, Berkeley, CA 94710-2753, United States.
2
Quattro Clinical Research, Oakland, CA 94609, United States.
3
Adjuvance Technologies, Inc., New York, NY, United States.
4
Dynavax Technologies Corporation, 2929 Seventh Street, Suite 100, Berkeley, CA 94710-2753, United States. Electronic address: rjanssen@dynavax.com.

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.

CONCLUSION:

HBsAg-1018 induced significantly higher seroprotection than HBsAg-Eng in CKD patients with diabetes.

KEYWORDS:

CKD; Hepatitis B vaccine; NCT00985426; Toll-like receptor 9; Type 2 diabetes

PMID:
25576215
DOI:
10.1016/j.vaccine.2014.12.060
[Indexed for MEDLINE]

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