Jin Li1, Deyou Zhang, Rui Ma, Xuqin Yang, Xi Wang, Caimei Li, Sucai Zhang, Hesheng Xue, Kai Zhao, Hui Zhuang. 1. Microbiology Department and Infectious Disease Center; School of Basic Medical Sciences; Peking University Health Science Center; Beijing, P.R. China; Vaccine Research Department II; Beijing Tiantan Biological Products Co., Ltd.; Beijing, P.R. China.
Abstract
AIMS: The current 3-dose regimen of hepatitis B vaccination for infants requiring over 6 mo period may pose the poor rate of compliance and later protection from hepatitis B virus (HBV) infection. This preclinical study is to investigate the feasibility of reducing the number of doses of hepatitis B (HB) vaccine. RESULTS: Eight groups of guinea pigs immunized with two doses of HP-HB vaccines at either 0 and 4 weeks or 0 and 8 weeks elicited geometric titers (GMT) of anti-HBs similar to that of four groups immunized with three doses of controls. The overall GMT of anti-HBs were not significantly different between the E- and C-groups (p>0.05) of monkeys. Specifically, the anti-HBs titers in the C-group reached the peak of 24857 (938.3-104585) mIU/mL one week after the 3rd dose, which were statistically higher than those of the E-group. However, they were reduced to comparable levels of anti-HBs in the E-group during weeks 9-12, suggesting comparable immune response of both vaccination regimens. METHODS: Twelve groups of guinea pigs (four animals in each group) were immunized with 2 experimental recombinant yeast Hansenula Polymorpha derived HB vaccines (HP-HB vaccine) and 2 commercial recombinant yeast Saccharomyces Cerevisiae vaccines (Temrevac-HB) as controls at 0, 4 and 8 weeks, 0 and 4 weeks, and 0 and 8 weeks respectively. Each guinea pig received 2 µg vaccine. Twelve Cynomolgus monkeys were randomly divided into two groups (six animals in each group). Animals in the experimental group (E-group) were injected with two doses of pilot produced 20 µg HP-HB vaccine. Animals in the control group (C-Group) were immunized with three doses of 10 µg Temrevac-HB. Both vaccines were administered at an interval of 3 weeks for monkeys. CONCLUSIONS: The 2-dose regimen of the HP-HB vaccine has comparable HBV immune responses as the 3-dose regimen of Temrevac-HB vaccine in Cynomolgus monkeys.
AIMS: The current 3-dose regimen of hepatitis B vaccination for infants requiring over 6 mo period may pose the poor rate of compliance and later protection from hepatitis B virus (HBV) infection. This preclinical study is to investigate the feasibility of reducing the number of doses of hepatitis B (HB) vaccine. RESULTS: Eight groups of guinea pigs immunized with two doses of HP-HB vaccines at either 0 and 4 weeks or 0 and 8 weeks elicited geometric titers (GMT) of anti-HBs similar to that of four groups immunized with three doses of controls. The overall GMT of anti-HBs were not significantly different between the E- and C-groups (p>0.05) of monkeys. Specifically, the anti-HBs titers in the C-group reached the peak of 24857 (938.3-104585) mIU/mL one week after the 3rd dose, which were statistically higher than those of the E-group. However, they were reduced to comparable levels of anti-HBs in the E-group during weeks 9-12, suggesting comparable immune response of both vaccination regimens. METHODS: Twelve groups of guinea pigs (four animals in each group) were immunized with 2 experimental recombinant yeastHansenula Polymorpha derived HB vaccines (HP-HB vaccine) and 2 commercial recombinant yeastSaccharomyces Cerevisiae vaccines (Temrevac-HB) as controls at 0, 4 and 8 weeks, 0 and 4 weeks, and 0 and 8 weeks respectively. Each guinea pig received 2 µg vaccine. Twelve Cynomolgus monkeys were randomly divided into two groups (six animals in each group). Animals in the experimental group (E-group) were injected with two doses of pilot produced 20 µg HP-HB vaccine. Animals in the control group (C-Group) were immunized with three doses of 10 µg Temrevac-HB. Both vaccines were administered at an interval of 3 weeks for monkeys. CONCLUSIONS: The 2-dose regimen of the HP-HB vaccine has comparable HBV immune responses as the 3-dose regimen of Temrevac-HB vaccine in Cynomolgus monkeys.
Authors: B G Gellin; R N Greenberg; R H Hart; J S Bertino; D H Stein; M A Deloria; M L Clements-Mann Journal: J Infect Dis Date: 1997-06 Impact factor: 5.226
Authors: J Crosnier; P Jungers; A M Couroucé; A Laplanche; E Benhamou; F Degos; B Lacour; P Prunet; Y Cerisier; P Guesry Journal: Lancet Date: 1981-04-11 Impact factor: 79.321