Heron Leon, Selnikova Olga, Moiseieva Anna, Van Damme Pierre, van der Wielen Marie, Levie Karin, Hoet Bernard, Stoffel Michel
National Center for Immunisation Research and Surveillance of Vaccine Preventable Diseases, Childrens Hospital, Westmead, Australia.
Vaccine. 2007 Apr 12;25(15):2817-22. doi: 10.1016/j.vaccine.2006.12.021. Epub 2006 Dec 29.
This trial assessed the immunogenicity, safety and reactogenicity of a two-dose hepatitis B immunisation regimen (thiomersal-free Engerix-B 20 microg HBsAg doses 6 months apart) compared to the standard three-dose vaccination regimen (preservative-free Engerix-B 10 microg HBsAg doses, 0, 1, 6 month dose schedule) in healthy adolescents aged 11-15 years. Subjects were randomly assigned (2:1 ratio) to one of the two regimens (258 to the two-dose [20 microg] and 126 to the three-dose [10 microg] regimen) (Study ID 103860/280). One month after the final vaccine dose, the seroprotection (anti-HBs >or=10mIU/ml) rate in the two-dose (20 microg) group (233/241 individuals -96.7% seroprotected) was non-inferior to the seroprotection rate in the three-dose (10 microg) group (111/113 individuals -98.2% seroprotected). Both regimens were shown to be safe and well tolerated. Two doses of Engerix-B (20 microg HBsAg) could be considered as an alternative to standard three-dose Engerix-B (10 microg HBsAg) immunisation for adolescents aged 11-15 years.
本试验评估了两剂乙肝免疫接种方案（不含硫柳汞的安在时-B，每剂含20微克乙肝表面抗原，间隔6个月）与标准三剂接种方案（不含防腐剂的安在时-B，每剂含10微克乙肝表面抗原，接种时间为0、1、6个月）在11至15岁健康青少年中的免疫原性、安全性和反应原性。受试者被随机分配（2:1比例）至两种方案之一（258人接受两剂[20微克]方案，126人接受三剂[10微克]方案）（研究编号103860/280）。在最后一剂疫苗接种后1个月，两剂（20微克）组的血清保护率（抗-HBs≥10mIU/ml）（233/241人 - 96.7%获得血清保护）不低于三剂（10微克）组的血清保护率（111/113人 - 98.2%获得血清保护）。两种方案均显示安全且耐受性良好。对于11至15岁的青少年，两剂安在时-B（20微克乙肝表面抗原）可被视为标准三剂安在时-B（10微克乙肝表面抗原）免疫接种的替代方案。
