title: 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.
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%.
  
  
  CONCLUSIONS
  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.
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: Dynavax Technologies Corporation, 2929 Seventh Street, Suite 100, Berkeley, CA 94710-2753, United States.
authors.forename: Sam
authors.initials: S
authors.lastname: Jackson
authors.affiliation: Quattro Clinical Research, 6114 LaSalle Ave., #727, Oakland, CA 94611, United States.
authors.forename: William L
authors.initials: WL
authors.lastname: Heyward
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 / Q000008:administration & dosage*; D000293:Adolescent; D000328:Adult; D000368:Aged; D005260:Female; D064368:Healthy Volunteers; D006510:Hepatitis B Antibodies / Q000097:blood*; D006514:Hepatitis B Surface Antigens / Q000276:immunology*; D017325:Hepatitis B Vaccines / Q000276:immunology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D051217:Toll-Like Receptor 9 / Q000819:agonists*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000276:Adjuvants, Immunologic; D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D051217:Toll-Like Receptor 9
keywords: Age; BMI; Hepatitis B vaccine; Sex; Smokers; Toll-like receptor 9