10年前按3、5、11月龄程序接种六价疫苗的健康儿童，接种一剂乙肝疫苗加强针后的安全性及免疫反应：意大利一项开放标签、对照、多中心试验
Safety and immune response to a challenge dose of hepatitis B vaccine in healthy children primed 10years earlier with hexavalent vaccines in a 3, 5, 11-month schedule: An open-label, controlled, multicentre trial in Italy.
作者信息
Zanetti Alessandro, Desole Maria Giuseppina, Romanò Luisa, d'Alessandro Antonio, Conversano Michele, Ferrera Giuseppe, Panico Maria Grazia, Tomasi Alberto, Zoppi Giorgio, Zuliani Massimo, Thomas Stéphane, Soubeyrand Benoît, Eymin Cécile, Lockhart Stephen
机构信息
Dipartimento di Scienze Biomediche per la Salute, Università degli Studi di Milano, 20133 Milano, Italy.
ASL di Sassari, Servizio di Igiene Pubblica, Via Rizzeddu, 21/b, 07100 Sassari, Italy.
出版信息
Vaccine. 2017 Jul 13;35(32):4034-4040. doi: 10.1016/j.vaccine.2017.05.047. Epub 2017 Jun 16.
BACKGROUND AND AIMS
The strategy of vaccinating infants to prevent hepatitis B virus infection in adolescence or adulthood requires durable immunity. This study investigated responses to a challenge dose of monovalent hepatitis B vaccine in children primed with three doses of either Hexavac® or Infanrix hexa® 10years earlier during infancy.
METHODS
This open-label, controlled, multicentre study conducted in Italy, enrolled 751 healthy pre-adolescents (aged 11-13years) who were given either Hexavac (n=409) or Infanrix hexa (n=342) at 3, 5 and 11months of life. All participants received a challenge dose of a monovalent hepatitis B vaccine (HBVaxPro® 5µg). The concentrations of antibodies to hepatitis B surface antigen (anti-HBs) were measured before and 1month after the challenge dose. The analysis was descriptive and no formal hypothesis was tested.
RESULTS
One month post-challenge, 331 participants in the Hexavac cohort [83.6%, 95% CI: 79.6; 87.1] and 324 in the Infanrix hexa cohort [96.4%, 95% CI: 93.8; 98.1] had anti-HBs concentrations ≥10mIU/mL. Before the challenge dose, an anti-HBs concentration of ≥10mIU/mL was found in 94 children in the Hexavac cohort [23.9%, 95% CI: 19.7; 28.4] and in 232 children in the Infanrix hexa cohort [69%, 95% CI: 63.8; 74.0]. Among children with a pre-challenge anti-HBs concentration of <10mIU/mL, 236 [78.7%, 95% CI: 73.6; 83.2] in the Hexavac cohort and 92 [88.5%, 95% CI: 80.7; 93.9] in the Infanrix hexa cohort achieved protective anti-HBs antibody concentrations. No evidence of active hepatitis B disease was observed in either group, and the HBVaxPro challenge dose was well tolerated.
CONCLUSIONS
These data confirm that immune memory persists in a high percentage of children (>80%) at least 10years after a two-dose primary and booster vaccination schedule with a hexavalent vaccine (Hexavac or Infanrix hexa).
TRIAL REGISTRATION
EudraCT Number: 2013-001602-28; clinicaltrials.gov: NCT02012998.
背景与目的
通过给婴儿接种疫苗以预防青少年期或成年期乙型肝炎病毒感染的策略需要持久的免疫力。本研究调查了10年前婴儿期接种过3剂Hexavac®或Infanrix hexa®的儿童对单价乙型肝炎疫苗激发剂量的反应。
方法
这项在意大利进行的开放标签、对照、多中心研究纳入了751名健康的青春期前儿童（11 - 13岁），他们在11个月、5个月和3个月时分别接种了Hexavac（n = 409）或Infanrix hexa（n = 342）。所有参与者均接受了一剂单价乙型肝炎疫苗（HBVaxPro® 5μg）的激发剂量。在激发剂量前及激发剂量后1个月测量乙型肝炎表面抗原抗体（抗-HBs）浓度。分析为描述性，未检验正式假设。
结果
激发后1个月，Hexavac队列中的331名参与者[83.6%，95%置信区间：79.6；87.1]和Infanrix hexa队列中的324名参与者[96.4%，95%置信区间：93.8；98.1]抗-HBs浓度≥10mIU/mL。在激发剂量前，Hexavac队列中的94名儿童[23.9%，95%置信区间：19.7；28.4]和Infanrix hexa队列中的232名儿童[69%，95%置信区间：63.8；74.0]抗-HBs浓度≥10mIU/mL。在激发前抗-HBs浓度<10mIU/mL的儿童中，Hexavac队列中的236名[78.7%，95%置信区间：73.6；83.2]和Infanrix hexa队列中的92名[88.5%，95%置信区间：80.7；93.9]达到了保护性抗-HBs抗体浓度。两组均未观察到活动性乙型肝炎疾病的证据，且HBVaxPro激发剂量耐受性良好。
结论
这些数据证实，在接受六价疫苗（Hexavac或Infanrix hexa）两剂基础免疫和加强免疫至少10年后，高比例（>80%）的儿童仍存在免疫记忆。
试验注册
欧洲药品管理局临床试验编号：2013 - 001602 - 28；美国国立医学图书馆临床试验注册中心编号：NCT02012998。
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