Vaccination in pregnancy using a tetanus toxoid, reduced dose diphtheria toxoid, and reduced dose acellular pertussis (Tdap) vaccine is important for prevention of severe pertussis disease in young infants. The objectives of this systematic literature review were to search for original research studies evaluating the vaccine effectiveness, immunogenicity, and safety of Adacel^®/Adacel-Polio^® used during pregnancy to prevent pertussis disease in young infants. Medical databases used included EMBASE, BIOSIS Previews, and Chemical Abstracts, with search terms related to pregnancy, vaccines/immunization, safety, pertussis, effectiveness/efficacy, and immune response; other potentially eligible reports were included where applicable. Search results were restricted to literature published from 1 January 1995 to 26 July 2021. A total of 2021 articles and 4 other reports were identified for primary review. A total of 49 publications qualified for inclusion after primary and secondary reviews. Effectiveness studies of Adacel or Adacel-Polio given in pregnancy consistently showed high levels of protection from pertussis disease in the newborn (vaccine effectiveness: 91–93%). In immunogenicity studies, the response in pregnant women was consistent with that of non-pregnant women. Infants of mothers vaccinated with Adacel or Adacel-Polio in pregnancy had higher anti-pertussis antibody levels at birth and at 2 months of age compared to infants born to women vaccinated with comparator vaccines, placebo, or those not vaccinated during pregnancy. There was evidence of a slightly decreased response to primary pertussis vaccination in infants of mothers vaccinated with Adacel or Adacel-Polio, but this was not thought to be clinically significant. In safety studies, Adacel or Adacel-Polio vaccination was well tolerated by pregnant woman and not associated with pregnancy, postpartum, or neonatal complications. In conclusion, Adacel or Adacel-Polio vaccination in pregnancy is highly effective in protecting young infants from pertussis disease, with a favorable safety profile for both pregnant women and their infants.

妊娠期使用破伤风类毒素、减剂量白喉类毒素和减剂量无细胞百日咳 (Tdap) 疫苗进行疫苗接种对于预防小婴儿严重百日咳疾病非常重要。本系统文献综述的目的是寻找原始研究，评估妊娠期间使用 Adacel ^® /Adacel-Polio ^®预防小婴儿百日咳的疫苗有效性、免疫原性和安全性。使用的医学数据库包括 EMBASE、BIOSIS Previews 和 Chemical Abstracts，搜索词涉及妊娠、疫苗/免疫、安全性、百日咳、有效性/功效和免疫反应；其他可能符合条件的报告也包括在适用的情况下。检索结果仅限于1995年1月1日至2021年7月26日发表的文献。共确定了2021篇文章和4篇其他报告进行初步审查。经过初审和复审，共有49篇出版物符合收录资格。怀孕期间给予 Adacel 或 Adacel-Polio 的有效性研究一致表明，对新生儿具有高水平的百日咳保护作用（疫苗有效性：91-93%）。在免疫原性研究中，孕妇的反应与非孕妇的反应一致。与接种对照疫苗、安慰剂或在怀孕期间未接种疫苗的妇女所生的婴儿相比，在怀孕期间接种 Adacel 或 Adacel-Polio 疫苗的母亲所生的婴儿在出生时和 2 个月大时抗百日咳抗体水平较高。有证据表明，接种 Adacel 或 Adacel-脊髓灰质炎疫苗的母亲所生的婴儿对初次百日咳疫苗的反应略有下降，但这并不被认为具有临床意义。 在安全性研究中，孕妇对 Adacel 或 Adacel-Polio 疫苗接种的耐受性良好，并且与妊娠、产后或新生儿并发症无关。总之，怀孕期间接种 Adacel 或 Adacel-Polio 疫苗对于保护幼儿免受百日咳疾病非常有效，对孕妇及其婴儿具有良好的安全性。