Department of Obstetrics, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, The Netherlands
Department of Datascience and Biostatistics, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
BMJ Glob Health. 2023 Oct;8(10). doi: 10.1136/bmjgh-2023-012376.
Maternal vaccination is a promising strategy to reduce the burden of vaccine-preventable diseases for mothers and infants. We aimed to provide an up-to-date overview of the efficacy and safety of all available maternal vaccines.
We searched PubMed, Embase, CENTRAL and ClinicalTrials.gov on 1 February 2022, for phase III and IV randomised controlled trials (RCTs) that compared maternal vaccination against any pathogen with placebo or no vaccination. Primary outcomes were laboratory-confirmed or clinically confirmed disease in mothers and infants. Secondary safety outcomes included intrauterine growth restriction, stillbirth, maternal death, preterm birth, congenital malformations and infant death. Random effects meta-analysis were used to calculate pooled risk ratio's (RR). Quality appraisal was performed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE).
Six RCTs on four maternal vaccines, influenza, tetanus, diphtheria and pertussis (Tdap), pneumococcal and respiratory syncytial virus (RSV) were eligible. The overall risk of bias and certainty of evidence varied from low to high. Maternal influenza vaccination significantly reduced the number of laboratory-confirmed influenza cases (RR 0.58, 95% CI 0.42 to 0.79, event rate 57 vs 98, 2 RCTs, n=6003, I=0%), and clinically confirmed influenza cases in mothers (RR 0.88, 95% CI 0.78 to 0.99, event rate 418 vs 472, 2 RCTs, n=6003, I=0%), and laboratory-confirmed influenza in infants (RR 0.66, 95% CI 0.52 to 0.85, event rate 98 vs 148, 2 RCTs, n=5883, I=0%), although this was not significant for clinically confirmed influenza in infants (RR 0.99, 95% CI 0.94 to 1.05, event rate 1371 vs 1378, 2 RCTs, n=5883, I=0%). No efficacy data were available on maternal Tdap vaccination. Maternal pneumococcal vaccination did not reduce laboratory-confirmed and clinically confirmed middle ear disease (RR 0.49, 95% CI 0.24 to 1.02, event rate 9 vs 18, 1 RCT, n=133 and RR 0.88 95% CI 0.69 to 1.12, event rate 42 vs 47, 1 RCT, n=133, respectively), and clinically confirmed lower-respiratory tract infection (LRTI) (RR 1.08, 95% CI 0.82 to 1.43, event rate 18 vs 34, 1 RCT, n=70) in infants. Maternal RSV vaccination did not reduce laboratory-confirmed RSV LRTI in infants (RR 0.75, 95% CI 0.56 to 1.01, event rate 103 vs 71, 1 RCT, n=4527). There was no evidence of a significant effect of any of the maternal vaccines on the reported safety outcomes.
The few RCTs with low event rates suggest that, depending on the type of maternal vaccine, the vaccine might effectively prevent disease and within its size does not show safety concerns in mothers and infants.
CRD42021235115.
母亲接种疫苗是减少母亲和婴儿疫苗可预防疾病负担的一种有前途的策略。我们旨在提供所有现有母亲疫苗的有效性和安全性的最新概述。
我们于 2022 年 2 月 1 日在 PubMed、Embase、CENTRAL 和 ClinicalTrials.gov 上搜索了三期和四期随机对照试验 (RCT)，这些试验比较了针对任何病原体的母亲疫苗接种与安慰剂或无疫苗接种。主要结局是母亲和婴儿的实验室确诊或临床确诊疾病。次要安全性结局包括宫内生长受限、死产、母亲死亡、早产、先天性畸形和婴儿死亡。使用随机效应荟萃分析计算汇总风险比 (RR)。使用 Grading of Recommendations, Assessment, Development and Evaluation (GRADE) 进行质量评估。
四项母亲疫苗（流感、破伤风、白喉和百日咳（Tdap）、肺炎球菌和呼吸道合胞病毒（RSV））的六项 RCT 符合条件。整体偏倚风险和证据确定性从低到高不等。母亲流感疫苗接种显著降低了实验室确诊的流感病例数量（RR 0.58，95%CI 0.42 至 0.79，事件发生率 57 对 98，2 项 RCT，n=6003，I=0%）和母亲临床确诊的流感病例（RR 0.88，95%CI 0.78 至 0.99，事件发生率 418 对 472，2 项 RCT，n=6003，I=0%），以及婴儿实验室确诊的流感病例（RR 0.66，95%CI 0.52 至 0.85，事件发生率 98 对 148，2 项 RCT，n=5883，I=0%），尽管婴儿临床确诊的流感病例无显著效果（RR 0.99，95%CI 0.94 至 1.05，事件发生率 1371 对 1378，2 项 RCT，n=5883，I=0%）。没有关于母亲 Tdap 疫苗接种的疗效数据。母亲肺炎球菌疫苗接种并未降低实验室确诊和临床确诊的中耳疾病（RR 0.49，95%CI 0.24 至 1.02，事件发生率 9 对 18，1 项 RCT，n=133 和 RR 0.88 95%CI 0.69 至 1.12，事件发生率 42 对 47，1 项 RCT，n=133）和婴儿临床确诊的下呼吸道感染（LRTI）（RR 1.08，95%CI 0.82 至 1.43，事件发生率 18 对 34，1 项 RCT，n=70）。母亲 RSV 疫苗接种并未降低婴儿实验室确诊的 RSV LRTI（RR 0.75，95%CI 0.56 至 1.01，事件发生率 103 对 71，1 项 RCT，n=4527）。没有证据表明任何一种母亲疫苗对报告的安全性结局有显著影响。
根据母亲疫苗的类型，低事件发生率的少数 RCT 表明，疫苗可能有效预防疾病，而且在其规模内，母亲和婴儿没有安全性问题。
CRD42021235115。
