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

Julia M Janssen; Sam Jackson; William L Heyward; Robert S Janssen

doi:10.1016/j.vaccine.2015.05.070

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

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

Authors

Julia M Janssen¹, Sam Jackson¹, William L Heyward², Robert S Janssen³

Affiliations

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.

PMID: 26067185
DOI: 10.1016/j.vaccine.2015.05.070

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.

Publication types

Clinical Trial, Phase III
Comparative Study
Research Support, Non-U.S. Gov't

MeSH terms

Adjuvants, Immunologic / administration & dosage*
Adolescent
Adult
Aged
Female
Healthy Volunteers
Hepatitis B Antibodies / blood*
Hepatitis B Surface Antigens / immunology*
Hepatitis B Vaccines / immunology*
Humans
Male
Middle Aged
Toll-Like Receptor 9 / agonists*
Treatment Outcome
Young Adult

Substances

Adjuvants, Immunologic
Hepatitis B Antibodies
Hepatitis B Surface Antigens
Hepatitis B Vaccines
Toll-Like Receptor 9