A controlled clinical trial comparing the safety and immunogenicity of a new adjuvanted hepatitis B vaccine with a standard hepatitis B vaccine

Vaccine. 2006 Nov 30;24(49-50):7167-74. doi: 10.1016/j.vaccine.2006.06.053. Epub 2006 Jul 12.


A randomised trial was conducted in 285 adults not immune to hepatitis B (HB) to compare the safety and immunogenicity of a commercial aluminium-adjuvanted HB vaccine with and without an additional new adjuvant (AgB/RC-210-04 or AgB study groups, respectively). The additional adjuvant RC-529 is a fully synthetic monosaccharide mimetic of monophosphoryl lipid A. Subjects in the AgB/RC-210-04 (n=136) and AgB (n=149) groups were vaccinated intramuscularly on days 0, 30, and 180, according to the standard vaccination schedule for hepatitis B vaccines. Serum levels of anti-HBs were measured on days 30, 60, 90, 180, and 210. Standard safety assessments were made throughout the study period. The rates of seroprotection (anti-HBs > or =10.0 mIU/ml) were significantly greater for the AgB/RC-210-04 group at all time points: at day 90, the seroprotection rate, the primary endpoint of the trial, was 99% for AgB/RC-210-04 compared with 84% for AgB (p<0.0001). Similarly, geometric mean anti-HBs titres were significantly higher at all time points for the AgB/RC-210-04 group. There were more local reactions in the AgB/RC-210-04 group, however they were transient and this double-adjuvanted formulation was well tolerated. We conclude that the addition of a synthetic adjuvant to the AgB vaccine significantly enhanced the immunogenicity of the commercial vaccine AgB. The results indicate furthermore that a two-dose regime of the double-adjuvanted vaccine (schedule: 0-1 month) may be sufficient to achieve seroprotection in nearly 100% of individuals.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • 1,2-Dipalmitoylphosphatidylcholine
  • Adjuvants, Immunologic
  • Adolescent
  • Adult
  • Cohort Studies
  • Dose-Response Relationship, Immunologic
  • Double-Blind Method
  • Excipients
  • Female
  • Hepatitis B / immunology*
  • Hepatitis B / prevention & control*
  • Hepatitis B Antibodies / analysis
  • Hepatitis B Antibodies / biosynthesis
  • Hepatitis B Surface Antigens / analysis
  • Hepatitis B Surface Antigens / immunology
  • Hepatitis B Vaccines / administration & dosage
  • Hepatitis B Vaccines / adverse effects*
  • Hepatitis B Vaccines / immunology*
  • Humans
  • Male
  • Suspensions


  • Adjuvants, Immunologic
  • Excipients
  • Hepatitis B Antibodies
  • Hepatitis B Surface Antigens
  • Hepatitis B Vaccines
  • Suspensions
  • 1,2-Dipalmitoylphosphatidylcholine