Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, Netherlands; European Programme for Intervention Epidemiology Training, European Centre for Disease Prevention and Control, Stockholm, Sweden.
Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, Netherlands.
Lancet Infect Dis. 2018 Jul;18(7):749-757. doi: 10.1016/S1473-3099(18)30166-X. Epub 2018 May 8.
In 2016, an increase in invasive Haemophilus influenzae serotype b (Hib) disease was reported in the Netherlands in children younger than 5 years, which coincided with the introduction of the hexavalent diphtheria, tetanus, and acellular pertussis-hepatitis B virus-inactivated polio virus/Hib vaccine (DTPa-HBV-IPV/Hib) from 2011 onwards. We aimed to estimate the effectiveness of the hexavalent vaccine to assess whether this increase could be explained by decreasing effectiveness.
We did a case-control study in the Netherlands. We selected patients with a Hib infection (cases) by use of the surveillance records of the Netherlands Reference Laboratory for Bacterial Meningitis (Amsterdam). Cases with a Hib infection that began from Jan 1, 2003, to Dec 31, 2016, and who were younger than age 5 years were included. Ten controls from the national vaccination register (Praeventis) were selected for each case, matched by date of birth. Vaccination status was ascertained by use of Praeventis, which details the vaccination records of children living in the Netherlands. The last recorded vaccine dose was used to classify the child as having received the hexavalent DTPa-HBV-IPV/Hib vaccine or a pentavalent vaccine (which excludes the hepatitis B virus component) or another vaccine. We estimated the effectiveness of these vaccines by use of conditional logistic regression.
We included 159 (94%) of 170 cases reported and 1590 matched controls, who had a median age of 1·5 years (IQR 0·8-2·9). The remaining 11 cases could not be cross-matched with vaccination records from Praeventis. 91 (57%) of 159 cases had been vaccinated, compared with 1408 (89%) of 1590 controls. The overall vaccine effectiveness was 92·8% (95% CI 88·7-95·4), with no differences between the year of disease onset (p=0·9670). There were no differences conferred by type of vaccine given: vaccine effectiveness of the pentavalent and other vaccines was 91·8% (95% CI 86·1-95·1) versus 94·0% (89·0-96·8) for the hexavalent vaccine (OR 0·72, 95% CI 0·36-1·45; p=0·3591). Vaccine effectiveness was highest in children aged 1-2 years at disease onset (97·1-99·0%) and was lowest in children aged 3-4 years at disease onset (60·7-82·3%; p=0·0008).
Our results support the current vaccination programme, since Hib vaccine effectiveness has not decreased over time or by the introduction of the hexavalent DTPa-HBV-IPV/Hib vaccine. Vaccine effectiveness was high but waned with age. Alternative explanations for the increase in Hib disease therefore need to be assessed.
Dutch Ministry of Health, Welfare and Sports.
2016 年，荷兰报告称，5 岁以下儿童侵袭性 B 型流感嗜血杆菌（Hib）疾病有所增加，这与 2011 年以来六价白喉、破伤风和无细胞百日咳-乙型肝炎病毒-灭活脊髓灰质炎病毒/Hib 疫苗（DTPa-HBV-IPV/Hib）的引入同时发生。我们旨在评估六价疫苗的有效性，以评估这种增加是否可以通过降低有效性来解释。
我们在荷兰进行了一项病例对照研究。我们通过荷兰细菌性脑膜炎参考实验室（阿姆斯特丹）的监测记录选择 Hib 感染（病例）患者。纳入的病例为 2003 年 1 月 1 日至 2016 年 12 月 31 日发病且年龄小于 5 岁的 Hib 感染者。对每个病例选择来自国家疫苗接种登记处（Praeventis）的 10 名匹配对照，按出生日期匹配。通过使用 Praeventis 确定疫苗接种状态，该登记处详细记录了居住在荷兰的儿童的疫苗接种记录。最后一次记录的疫苗剂量用于将儿童分类为接受六价 DTPa-HBV-IPV/Hib 疫苗、五价疫苗（不含乙型肝炎病毒成分）或其他疫苗。我们使用条件逻辑回归估计这些疫苗的有效性。
我们纳入了报告的 159 例（94%）病例和 1590 例匹配对照，这些病例的中位年龄为 1.5 岁（IQR 0.8-2.9）。其余 11 例病例无法与 Praeventis 的疫苗接种记录交叉匹配。159 例病例中有 91 例（57%）接种过疫苗，而 1590 例对照中有 1408 例（89%）接种过疫苗。总体疫苗有效性为 92.8%（95%CI 88.7-95.4），发病年份之间无差异（p=0.9670）。所给予的疫苗类型之间没有差异：五价疫苗和其他疫苗的疫苗有效性分别为 91.8%（95%CI 86.1-95.1）和 94.0%（89.0-96.8）的六价疫苗（OR 0.72，95%CI 0.36-1.45；p=0.3591）。发病年龄在 1-2 岁的儿童疫苗有效性最高（97.1-99.0%），发病年龄在 3-4 岁的儿童疫苗有效性最低（60.7-82.3%；p=0.0008）。
我们的结果支持当前的疫苗接种计划，因为 Hib 疫苗的有效性并未随着时间的推移或六价 DTPa-HBV-IPV/Hib 疫苗的引入而降低。疫苗有效性很高，但随着年龄的增长而减弱。因此，需要评估 Hib 疾病增加的其他解释。
荷兰卫生、福利和体育部。
