Infant antibody levels following 10-valent pneumococcal-protein D conjugate and DTaP-Hib vaccinations in the first year of life after maternal Tdap vaccination: An open-label, parallel, randomised controlled trial
Infant antibody levels following 10-valent pneumococcal-protein D conjugate and DTaP-Hib vaccinations in the first year of life after maternal Tdap vaccination: An open-label, parallel, randomised controlled trial
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DOI：
10.1016/j.vaccine.2020.04.001
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发表时间：
2020-06-15
期刊：
影响因子：
5.5
通讯作者：
Rots, Nynke Y.
中科院分区：
文献类型：
--
作者：
Barug, Daan;Berbers, Guy A. M.;Rots, Nynke Y.
背景资料：妊娠期间接种Tdap疫苗后的母体抗体水平可能会影响婴儿对百日咳、破伤风类毒素（TT）、白喉类毒素（DT）疫苗和以白喉毒素突变体（如CRM 197）为载体蛋白的肺炎球菌疫苗的初级抗体应答。她们在妊娠30-32周（n = 58）或分娩后48小时内（n = 60）接受Tdap [Boostrix]。婴儿在3、5和11个月时接受DTaP-IPV-Hib-HepB [Infanrix Hexa]和10价蛋白D结合肺炎球菌结合疫苗（PHiD-CV10 [Synflorix]）。我们现在报告了初次和加强疫苗接种前后婴儿对DT、TT、B型流感嗜血杆菌多聚核糖基核糖醇反式磷酸盐（HiB PRP）和PHiD-CV 10的特异性IgG水平，作为次要研究终点;百日咳抗体是研究的主要终点。该试验在clinicaltrialsregister.eu（EudraCT 2012-004006-9）和trialregister.nl（NTR编号NTR 4314）中注册。结果：初次接种后，妊娠期间Tdap疫苗接种后，DT抗体水平显著低于对照组（GMC比率分别为0.4，95% CI 0.3-0.6和0.9，95% CI 0.6-1.2）。血清型19 F的抗体显着较低的母亲Tdap组，而Hib PRP和其他9种肺炎球菌血清型的抗体水平没有差异。后加强疫苗接种，没有观察到显着差异，除了DT。解释：母亲Tdap疫苗接种结果显着干扰婴儿的反应不仅DT，但也结合肺炎球菌疫苗DT突变体作为载体蛋白。在设计婴儿的国家免疫计划和选择疫苗时，需要考虑到母亲接种Tdap疫苗后的这些相互作用。(C)2020由Elsevier Ltd.出版
Background: Maternal antibody levels after Tdap vaccination during pregnancy may affect infant primary antibody responses to pertussis, Tetanus toxoid (TT), Diphtheria toxoid (DT) vaccinations and pneumococcal vaccines with diphtheria toxin mutants like CRM197 as carrier protein.Methods: Mothers were recruited in an open label randomised parallel controlled trial in 2014-2016 through midwifes. They received Tdap [Boostrix] at 30-32 weeks of pregnancy (n = 58) or within 48 h after delivery (n = 60). Infants received DTaP-IPV-Hib-HepB [Infanrix Hexa] and 10-valent protein D con-jugated pneumococcal conjugate vaccine (PHiD-CV10 [Synflorix]) at age 3, 5 and 11 months. We now report on infant specific IgG levels towards DT, TT, Haemophilus influenzae type b polyribosylribitol phos-phate (Hib PRP) and PHiD-CV10 before and after primary- and booster vaccination as secondary study endpoints; pertussis antibodies were the primary endpoint of the study. This trial is registered in clinicaltrialsregister.eu (EudraCT 2012-004006-9) and trialregister.nl (NTR number NTR4314).Findings: Post primary vaccinations, antibody levels to DT, but not TT, were significantly lower after Tdap vaccination during pregnancy compared to controls (GMC ratio 0.4, 95% CI 0.3-0.6 and 0.9, 95% CI 0.6-1.2, respectively). Antibodies to serotype 19F were significantly lower in the maternal Tdap group, whereas there were no differences in antibody levels to Hib PRP and the other 9 pneumococcal serotypes. Post booster vaccinations, no significant differences were observed, except for DT.Interpretation: Maternal Tdap vaccination results in significant interference with infants responses not only to DT but also to conjugated pneumococcal vaccines containing DT mutants as carrier proteins. These interactions after maternal Tdap vaccination need to be taken into account when designing infants' national immunization schedules and choice of vaccines. (C) 2020 Published by Elsevier Ltd.