在婴儿期接种4剂六价DTPa-HBV-IPV / Hib疫苗的14-15岁青少年长期

StephenW

Hum Vaccin Immunother. 2018 Aug 17. doi: 10.1080/21645515.2018.1509658. [Epub ahead of print]
Long-term antibody persistence against hepatitis B in adolescents 14-15-years of age vaccinated with 4 doses of hexavalent DTPa-HBV-IPV/Hib vaccine in infancy.
Schwarz TF1, Behre U2, Adelt T3, Donner M4, Suryakiran PV5, Janssens W6, Mesaros N6, Panzer F7.
Author information

1
    a Institute of Laboratory Medicine and Vaccination Centre , Klinikum Würzburg Mitte, Standort Juliusspital , Würzburg , Germany.
2
    b Pediatric Practice , Kehl , Baden-Württemberg , Germany.
3
    c Pediatric Practice , Bramsche , Germany.
4
    d Pediatric Practice , Mönchengladbach , Germany.
5
    e GSK , Bangalore , India.
6
    f GSK , Wavre , Belgium.
7
    g Pediatric Practice , Mannheim , Germany.

Abstract

We evaluated antibody persistence against hepatitis B virus (HBV) in adolescents previously vaccinated with a hexavalent diphtheria-tetanus-acellular pertussis-HBV-inactivated poliovirus-Haemophilus influenzae type b conjugate vaccine (DTPa-HBV-IPV/Hib), as part of the national newborn immunization program in Germany. We also assessed the anamnestic response to a challenge dose of a monovalent HBV vaccine. In this phase 4, open-label, non-randomized study (NCT02798952), 302 adolescents aged 14-15 years, primed in their first 2 years of life with 4 DTPa-HBV-IPV/Hib doses, received one challenge dose of monovalent HBV vaccine. Blood samples were taken before and one month post-vaccination and used to determine antibody levels against hepatitis B surface antigen (HBs). Reactogenicity and safety were also assessed post-challenge dose. Pre-challenge dose, 53.7% of 268 participants included in the according-to-protocol cohort for immunogenicity had anti-HBs antibody concentrations ≥10 mIU/mL (seroprotection cut-off) and 16.8% had anti-HBs antibody concentrations ≥100 mIU/mL. One month post-challenge dose, 93.3% of adolescents had anti-HBs antibody concentrations ≥10 mIU/mL and 87.3% had antibody concentrations ≥100 mIU/mL. An anamnestic response was mounted in 92.5% of adolescents. Injection site pain (in 33.6% of participants) and fatigue (30.2%) were the most frequently reported solicited local and general symptoms, respectively. Six of the 55 unsolicited adverse events reported were considered vaccination-related. Two vaccination-unrelated serious adverse events were reported during the study. Long-term antibody persistence against hepatitis B was observed in 14-15 years old adolescents previously primed in infancy with DTPa-HBV-IPV/Hib. A challenge dose of monovalent HBV vaccine induced strong anamnestic response, with no safety concerns.
KEYWORDS:

DTPa-HBV-IPV/Hib; Hepatitis B; adolescents; anamnestic response; challenge dose; immune memory; long-term persistence; seroprotection

PMID:
    30118633
DOI:
    10.1080/21645515.2018.1509658

StephenW

Hum Vaccin Immunother。 2018年8月17日doi：10.1080 / 21645515.2018.1509658。 [提前打印]
在婴儿期接种4剂六价DTPa-HBV-IPV / Hib疫苗的14-15岁青少年长期抗乙型肝炎抗体持续存在。
Schwarz TF1，Behre U2，Adelt T3，Donner M4，Suryakiran PV5，Janssens W6，Mesaros N6，Panzer F7。
作者信息

1
    德国维尔茨堡Standlin Juliusspital的KlinikumWürzburgMitte实验室医学和疫苗接种中心。
2
    b儿科实践，Kehl，Baden-Württemberg，德国。
3
    c儿科实践，德国Bramsche。
4
    d儿科实践，德国门兴格拉德巴赫。
五
    e GSK，班加罗尔，印度。
6
    f GSK，比利时瓦夫尔。
7
    g儿科实践，德国曼海姆。

抽象

我们评估了先前接种六价白喉 - 破伤风 - 无细胞百日咳-HBV灭活脊髓灰质炎病毒 - 乙型流感嗜血杆菌b型结合疫苗（DTPa-HBV-IPV / Hib）的青少年抗乙型肝炎病毒（HBV）的抗体持久性，作为德国国家新生儿免疫计划。我们还评估了对单价HBV疫苗的攻击剂量的回忆反应。在这个阶段4，开放标签，非随机研究（NCT02798952），302名年龄在14-15岁的青少年，在他们的前2年内用4种DTPa-HBV-IPV / Hib剂量引发，接受一种单价的挑战剂量HBV疫苗。在接种前和接种后一个月采集血样并用于确定针对乙型肝炎表面抗原（HBs）的抗体水平。攻击后剂量也评估了反应原性和安全性。攻击前剂量，包括在根据协议的免疫原性队列中的268名参与者中，53.7％的抗HBs抗体浓度≥10mIU/ mL（血清保护切断），16.8％的抗HBs抗体浓度≥100mIU /毫升。攻击后一个月，93.3％的青少年抗-HBs抗体浓度≥10mIU/ mL，87.3％的抗体浓度≥100mIU/ mL。对92.5％的青少年进行了回忆性反应。注射部位疼痛（33.6％的参与者）和疲劳（30.2％）是最常报告的局部和一般症状。报告的55个未经请求的不良事件中有6个被认为与疫苗接种有关。研究期间报告了两次与疫苗无关的严重不良事件。在早期用DTPa-HBV-IPV / Hib引发婴儿的14-15岁青少年中观察到长期抗乙型肝炎持续存在。单价HBV疫苗的攻击剂量诱导了强烈的记忆反应，没有安全问题。
关键词：

DTPA-HBV-IPV /乙型流感嗜血杆菌;乙型肝炎;青少年;回忆反应;挑战剂量;免疫记忆;长期坚持;血清保护

结论：
    30118633
DOI：
    10.1080 / 21645515.2018.1509658