University Hospital for Children and Adolescents, Leipzig, Germany.
BMC Infect Dis. 2010 Jan 15;10:9. doi: 10.1186/1471-2334-10-9.
Few studies have assessed long term persisting immunity against hepatitis B virus (HBV) in children vaccinated during infancy with combined vaccines containing recombinant HBV surface antigen (HBs). We assessed antibody persistence and immune memory in children 4-5 years of age, previously vaccinated with four doses of combined hexavalent DTPa-HBV-IPV/Hib vaccine (Infanrix hexa).
Immune memory was assessed in 301 children through administration of a challenge dose of monovalent HBV vaccine.
At 4-5 years of age, 85.3% of subjects had persisting anti-HBs antibody concentrations >or= 10 mIU/mL, rising to 98.6% after the HBV challenge dose. All but 12 subjects (95.8%) achieved post-challenge anti-HBs concentrations >or= 100 mIU/mL. The post-challenge anti-HBs GMC rose by 100-fold compared to pre-challenge concentrations. An anamnestic response to the HBV vaccine challenge was observed in 96.8% of subjects, including 17/21 (81.0%) of children with initially undetectable antibodies (<3.3 mIU/mL). All but 4 of 42 subjects (90.5%) with anti-HBs antibodies <10 mIU/mL prior to the challenge dose, achieved seroprotective levels afterwards. A 4-fold rise in antibody concentration after the challenge dose was observed in 259/264 (98.1%) of initially seropositive subjects. The magnitude of the post-challenge responses was proportional to pre-challenge anti-HBs levels. No serious adverse events were reported during the study.
The combined DTPa-HBV-IPV/Hib vaccine induced lasting immune memory against hepatitis B. Long term protection afforded by DTPa-HBV-IPV/Hib is likely to be similar to that observed following priming with monovalent HBV vaccines.
http://www.clinicaltrials.gov 106789 NCT00411697.
在婴儿期使用包含重组乙型肝炎病毒表面抗原（HBs）的联合疫苗进行免疫接种的儿童中，很少有研究评估乙型肝炎病毒（HBV）长期持续免疫。我们评估了以前接种过四剂六价 DTPa-HBV-IPV/Hib 疫苗（Infanrix hexa）的儿童在 4-5 岁时的抗体持久性和免疫记忆。
通过给予单价 HBV 疫苗的挑战剂量，评估了 301 名儿童的免疫记忆。
在 4-5 岁时，85.3%的受试者抗-HBs 抗体浓度>或=10mIU/mL，在接受 HBV 挑战剂量后上升至 98.6%。除 12 名（95.8%）受试者外，所有受试者均获得>或=100mIU/mL的抗-HBs 浓度。与预挑战浓度相比，挑战后抗-HBs 的几何平均浓度（GMC）增加了 100 倍。96.8%的受试者对 HBV 疫苗挑战产生了记忆应答，包括 17/21（81.0%）最初抗体检测不到（<3.3mIU/mL）的儿童。在接受挑战剂量之前，42 名抗-HBs 抗体<10mIU/mL的儿童中，除 4 名外，其余儿童均获得了保护性水平。在 259/264（98.1%）最初血清阳性的受试者中，在接受挑战剂量后，抗体浓度增加了 4 倍。挑战后反应的幅度与预挑战抗-HBs 水平成正比。研究期间未报告严重不良事件。
联合 DTPa-HBV-IPV/Hib 疫苗诱导了针对乙型肝炎的持久免疫记忆。DTPa-HBV-IPV/Hib 提供的长期保护可能与单剂 HBV 疫苗接种后观察到的保护相似。
http://www.clinicaltrials.gov 106789 NCT00411697。
