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Vaccine. 2015 Jul 17;33(31):3614-8. doi: 10.1016/j.vaccine.2015.05.070. Epub 2015 Jun 9.

Immunogenicity of an investigational hepatitis B vaccine with a toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared with a licensed hepatitis B vaccine in subpopulations of healthy adults 18-70 years of age.

Author information

1
Dynavax Technologies Corporation, 2929 Seventh Street, Suite 100, Berkeley, CA 94710-2753, United States.
2
Quattro Clinical Research, 6114 LaSalle Ave., #727, Oakland, CA 94611, United States.
3
Dynavax Technologies Corporation, 2929 Seventh Street, Suite 100, Berkeley, CA 94710-2753, United States. Electronic address: rjanssen@dynavax.com.

Abstract

BACKGROUND:

Immunologic response to a complete vaccine regimen of currently licensed alum-adjuvanted hepatitis B vaccines is reduced in several subpopulations, including older adults, men, obese persons, and smokers. Two phase 3 trials in healthy adults demonstrated that 2 doses over 1 month of an investigational hepatitis B vaccine (HBsAg-1018) induced superior seroprotection rates (SPRs) to 3 doses over 6 months of the licensed vaccine Engerix-B (HBsAg-Eng).

METHODS:

An exploratory analysis of immunogenicity was conducted in subpopulations from pooled data for the 2 phase 3 trials.

RESULTS:

In each subpopulation, the peak SPR in the HBsAg-1018 group was statistically significantly higher than the peak SPR in the HBsAg-Eng group. Peak HBsAg-1018 SPRs ranged from 91.6% to 99.7%, while peak HBsAg-Eng SPRs ranged from 67.7% to 92.9%.

CONCLUSION:

In these exploratory analyses, 2 doses of HBsAg-1018 induced statistically significantly higher rates of seroprotection than 3 doses of HBsAg-Eng across all subpopulations.

KEYWORDS:

Age; BMI; Hepatitis B vaccine; Sex; Smokers; Toll-like receptor 9

PMID:
26067185
DOI:
10.1016/j.vaccine.2015.05.070
[Indexed for MEDLINE]

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