Gilca Vladimir, De Serres Gaston, Boulianne Nicole, De Wals Philippe, Murphy Donald, Trudeau Gisele, Massé Richard, Duval Bernard
Institut national de santé publique du Québec, Laval University, Quebec, Canada.
Vaccine. 2009 Oct 9;27(43):6048-53. doi: 10.1016/j.vaccine.2009.07.100. Epub 2009 Aug 13.
Few data are available concerning the persistence of anti-HBs and the effect of booster doses given several years post-vaccination against hepatitis B during preadolescence. The objective of this open-labelled clinical trial was to evaluate the persistence of antibodies after vaccination with three paediatric doses of Engerix-B at the age of 8-10 years and the effect of a booster dose given 5 (Group Y5) or 10 (Group Y10) years later. Anti-HBs were measured before and one month post-primary vaccination, then 5 and 10 years later, before the booster dose, as well as one month and 1 year post-booster. The anamnestic response was defined as a >or=fourfold increase of anti-HBs post-booster (>or=10 IU/L) when compared to pre-booster. Ten years post-primary vaccination, 559 of the 652 initially randomized subjects (86%) were eligible for analysis. Group Y5, 5 years post-booster results: 99% of subjects had detectable levels of antibodies and 96% a titer >or=10 IU/L. The anti-HBs GMTs decreased from 114,489 IU/L one month post-booster to 3354 IU/L 5 years later. Group Y10 results: 10 years post-primary vaccination 96% of subjects had a detectable level of anti-HBs and 85% were above the threshold of 10 IU/L. The GMTs one month post-booster were 31,030 IU/L. The challenge with a booster demonstrated an anamnestic response in 99% of subjects in group Y5 and 100% of subjects in group Y10. All subjects were anti-HBc negative. The booster doses were well tolerated. The excellent anamnestic response observed after the booster dose demonstrates the persistence of immunity in virtually all young adults vaccinated at the age of 8-10 with three paediatric doses of Engerix-B.
关于乙肝表面抗体(anti-HBs)的持久性以及青春期前接种乙肝疫苗数年之后加强剂量的效果,现有数据较少。这项开放标签临床试验的目的是评估8至10岁儿童接种三剂重组酵母乙肝疫苗(Engerix-B)后抗体的持久性,以及5年(Y5组)或10年(Y10组)后加强剂量的效果。在初次接种疫苗前、接种后1个月、5年和10年后(加强剂量前)以及加强剂量后1个月和1年检测anti-HBs。回忆反应定义为加强剂量后anti-HBs较加强剂量前升高≥4倍(≥10 IU/L)。初次接种疫苗10年后,652名最初随机分组的受试者中有559名(86%)符合分析条件。Y5组,加强剂量5年后结果:99%的受试者可检测到抗体水平,96%的受试者滴度≥10 IU/L。加强剂量后1个月anti-HBs几何平均滴度(GMT)为114,489 IU/L,5年后降至3354 IU/L。Y10组结果:初次接种疫苗10年后,96%的受试者可检测到anti-HBs水平,85%的受试者高于10 IU/L的阈值。加强剂量后1个月GMT为31,030 IU/L。加强剂量激发试验显示,Y5组99%的受试者和Y10组100%的受试者出现回忆反应。所有受试者乙肝核心抗体(anti-HBc)均为阴性。加强剂量耐受性良好。加强剂量后观察到的出色回忆反应表明,几乎所有8至10岁接种三剂重组酵母乙肝疫苗(Engerix-B)的年轻成年人都保持着免疫力。