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.
Hum Vaccin Immunother. 2013 Apr;9(4):736-43. doi: 10.4161/hv.23227. Epub 2013 Jan 31.
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.
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.
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.
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.
婴儿需要超过 6 个月的时间才能完成乙肝疫苗接种的 3 剂方案，这可能会导致较差的依从性，并且以后容易受到乙肝病毒（HBV）感染。本临床前研究旨在探讨减少乙肝（HB）疫苗剂量的可行性。
8 组豚鼠分别在 0 周和 4 周或 0 周和 8 周时接种 2 剂 HP-HB 疫苗，抗-HBs 的几何平均滴度（GMT）与 4 组接种 3 剂对照疫苗的 GMT 相似。两组猴子的抗-HBs 总体 GMT 无显著差异（p＞0.05）。具体而言，第 3 剂后 1 周，C 组的抗-HBs 滴度达到峰值 24857（938.3-104585）mIU/mL，显著高于 E 组。然而，在第 9-12 周，E 组的抗-HBs 滴度下降到与 C 组相当的水平，表明两种免疫方案具有相似的免疫反应。
12 组豚鼠（每组 4 只）分别在 0、4 和 8 周、0 和 4 周、0 和 8 周时用 2 种实验性重组酵母汉逊酵母衍生的 HB 疫苗（HP-HB 疫苗）和 2 种商业重组酵母酿酒酵母疫苗（Temrevac-HB）作为对照进行免疫，每只豚鼠接种 2 µg 疫苗。12 只食蟹猴随机分为两组（每组 6 只）。实验组（E 组）猴接种两剂试验生产的 20 µg HP-HB 疫苗。对照组（C 组）猴接种三剂 10 µg Temrevac-HB 疫苗。两种疫苗均间隔 3 周用于猴。
在食蟹猴中，HP-HB 疫苗的 2 剂方案与 Temrevac-HB 疫苗的 3 剂方案具有相当的 HBV 免疫反应。
