Comparison of a triple antigen and a single antigen recombinant vaccine for adult hepatitis B vaccination*

Abstract

Hepatitis B and its sequelae are a major public health problem. Vaccines have been available for almost 20 years; however the disease still remains a global problem. Many factors contribute to the failure to control hepatitis B, including the limited nature of the vaccination programs implemented initially. Only relatively recently has mass childhood vaccination begun to be implemented and vaccination of high-risk groups, other than healthcare workers, is still not general policy. Additional factors contributing to continued persistence of hepatitis B in the developed world are that the present vaccines are not fully used by those recommended to be vaccinated and even when vaccination is carried out appropriately, there remain some who fail to achieve adequate protection. Clearly, the protection of at-risk groups who have inadequate response to current vaccines, and those who are unwilling or unable to comply with protracted multi-dose vaccine regimens, could be improved if there were a more potent vaccine and/or a shorter vaccination regimen available. Adults who had never been vaccinated against hepatitis B were randomised to receive a vaccination course of either a present single antigen (S) vaccine (Recombivax-HB) or a novel triple antigen (S, pre-S1, and pre-S2) recombinant vaccine (Hepacare Medeva Pharma plc). Doses were given at baseline and 1 month and 6 months later. Hepatitis B surface antibody (anti-HBs) levels were measured at 2, 4, 6, and 7 months after beginning vaccination. The primary efficacy parameter was the degree of protection, measured as the percentage of subjects with anti-HBs titres > or = 10 IU/L, 6 or 7 months (26 +/- 2 weeks) after beginning vaccination. A total of 303 adult subjects entered the study and were vaccinated. Of these, 11 failed to complete the study (4 on Hepacare and 7 on Recombivax-HB); however all but 2 (1 to receive the triple antigen vaccine and 1 to receive Recombivax-HB) were included in the intent-to-treat population for efficacy evaluation. Treatment randomisation was stratified at entry based on age (above and below 40 years old) and gender. The standard three-dose/6-month vaccination regimen of the single antigen vaccine protected 83% of subjects by 7 months after starting vaccination whereas the triple antigen vaccine as a two-dose/1-month regimen protected 88% within 6 months and as a three-dose/6-month regimen protected 97% by 7 months after starting vaccination. Thus the protection rate provided by the shortened (0, 1) regimen of the novel vaccine was "essentially equivalent" (i.e., not statistically inferior) to that provided by the full (0, 1, and 6) regimen of today's vaccine (88% vs. 81%, P < 0.001), and the protection rate provided by a three-dose/6-month (0, 1, and 6) regimen of the new vaccine was significantly superior to that provided by present vaccines (97% vs. 83% P < 0.001). The percentage of subjects protected increases with time after beginning vaccination and at all time points up to and including 6 months was significantly greater with the ...

Immunological effects of a 10-μg dose of domestic hepatitis B vaccine in adults

“…Its seroconversion rate reached 95.05%, a rate significantly higher than those of the other three groups. This seroconversion rate was also similar to that of the 20 μg hepatitis B vaccine reported by Young et al (2001). This similarity might be caused by the high purity of the Hansenula hepatitis B vaccine, which uses a chemosynthesis complete medium only, and not a selective medium, peptone or yeast powder.…”

“…This similarity might be caused by the high purity of the Hansenula hepatitis B vaccine, which uses a chemosynthesis complete medium only, and not a selective medium, peptone or yeast powder. The seroconversion rates of the 10 μg hepatitis B vaccine produced by the North China Pharmaceutical Company and GlaxoSmithKline were slightly higher than that of the 10 μg hepatitis B vaccine previously reported by Young et al (2001). Regarding the anti-HBs GMT, the immune effects for all the vaccines were good, except those of the Shenzhen Kangtai vaccine.…”

Efficacy of an Accelerated Hepatitis B Vaccination Program During Pregnancy

“…Although limited data are available, small studies have reported improved seroconversion rates in obese patients with increasing needle length, dose and formulation of vaccine, and weight reduction surgery. [21][22][23][24] Other factors that have been found to correlate poorly with immune response such as smoking and age were not associated with seroconversion in our cohort. Compliance rates for hepatitis B vaccination completion varies depending on the population.…”

Correlation between serum alanine aminotransferase activity and immunologic response and body mass index in obese patients with chronic hepatitis B virus infection

“…Further, Simo Minnana et al reported lower antibody response in adolescents with high BMI when administered a three-dose regimen of recombinant hepatitis B vaccine (20). A randomized controlled trial compares triple-antigen vaccine vs standard single antigen vaccine administered in three doses over six months resulted in 71% and 95% protection rates in obese subjects when compared with lean subjects (91% & 99% respectively) (21). Therefore, the purpose of this study was to examine the correlation between body mass index, serum alanine aminotransferase activity and immunologic response in obese hepatitis B virus patients.…”