Chaithongwongwatthana Surasith, Wijagkanalan Wassana, Wanlapakorn Nasamon, Fortuna Librada, Yuwaree Vilasinee, Kerdsomboon Chawanee, Poredi Indrajeet Kumar, Mansouri Souad, Pham Hong Thai, Poovorawan Yong
Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
BioNet-Asia, Bangkok, Thailand.
Int J Infect Dis. 2024 Jul;144:107047. doi: 10.1016/j.ijid.2024.107047. Epub 2024 Apr 11.
AIM/OBJECTIVE: This study investigates placental antibody transfer following recombinant pertussis vaccination in pregnancy in a real-world setting.
This postmarketing observational study recruited pregnant women vaccinated with monovalent recombinant acellular pertussis (aP) vaccine (aP; n = 199) or combined to tetanus-diphtheria (TdaP; n = 200), or Td-vaccine only (n = 54). Pregnancy, delivery, and neonatal outcomes were assessed. Cord blood was collected postdelivery and pertussis toxin (PT)-IgG, filamentous hemagglutinin (FHA)-IgG, and PT-neutralizing antibodies (PT-Nab) were assessed.
No adverse pregnancy, delivery, or neonatal outcomes attributed to aP TdaP, or Td vaccination were reported. High anti-PT antibody levels were detected in cord samples from women vaccinated with aP (geometric mean concentration [GMC] PT-IgG 206.1 IU/ml, 95% confidence intervals [CI]: 164.3-258.6; geometric mean titer [GMT] PT-Nab 105.3 IU/ml, 95% CI: 81.7-135.8) or TdaP (GMC PT-IgG 153.1 IU/ml, 95% CI: 129.1-181.5; GMT PT-Nab 81.5 IU/ml, 95% CI: 66.4-100.0). In the Td-only group, anti-PT antibodies were low (GMC PT-IgG 6.5 IU/ml, 95% CI: 4.9-8.8; GMT PT-Nab 3.8 IU/ml, 95% CI: 2.8-5.1). The same was found for FHA-IgG. Recombinant pertussis vaccination at <27 or 27-36 weeks gestation induced similar cord pertussis antibody levels.
This first real-world study confirms that recombinant pertussis vaccination in the second or third trimester of pregnancy results in high levels of passive immunity in infants. Thai Clinical Trial Registry: TCTR20200528006.
本研究在实际环境中调查孕期接种重组百日咳疫苗后的胎盘抗体转移情况。
这项上市后观察性研究招募了接种单价重组无细胞百日咳疫苗(aP;n = 199)或与破伤风 - 白喉联合疫苗(TdaP;n = 200)或仅接种Td疫苗(n = 54)的孕妇。评估妊娠、分娩和新生儿结局。产后采集脐带血并评估百日咳毒素(PT)-IgG、丝状血凝素(FHA)-IgG和PT中和抗体(PT-Nab)。
未报告因接种aP、TdaP或Td疫苗导致的不良妊娠、分娩或新生儿结局。在接种aP(几何平均浓度[GMC]PT-IgG 206.1 IU/ml,95%置信区间[CI]:164.3 - 258.6;几何平均滴度[GMT]PT-Nab 105.3 IU/ml,95%CI:81.7 - 135.8)或TdaP(GMC PT-IgG 153.1 IU/ml,95%CI:129.1 - 181.5;GMT PT-Nab 81.5 IU/ml,95%CI:66.4 - 100.0)的女性脐带样本中检测到高抗PT抗体水平。在仅接种Td疫苗的组中,抗PT抗体水平较低(GMC PT-IgG 6.5 IU/ml,95%CI:4.9 - 8.8;GMT PT-Nab 3.8 IU/ml,95%CI:2.8 - 5.1)。FHA-IgG情况相同。妊娠<27周或27 - 36周时接种重组百日咳疫苗诱导的脐带百日咳抗体水平相似。
这项首次实际研究证实,孕期第二或第三阶段接种重组百日咳疫苗可使婴儿获得高水平的被动免疫。泰国临床试验注册:TCTR20200528006。