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Impact of the 23-valent pneumococcal polysaccharide vaccination in pregnancy against infant acute lower respiratory infections in the Northern Territory of Australia

机译：怀孕23价肺炎球菌多糖疫苗接种对澳大利亚北领地婴儿急性下呼吸道感染的影响

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Background Indigenous children in Australia’s Northern Territory are densely colonised with the pneumococcus within weeks of birth antecedent to a high prevalence of acute lower respiratory infection (ALRI). We assessed the impact of the 23-valent pneumococcal polysaccharide vaccine (23vPPV) in pregnancy against infant ALRI in this setting. Methods In an open label, allocation concealed, outcome-assessor blinded, randomised controlled trial conducted in the Northern Territory of Australia, healthy Indigenous women aged 17–39?years were randomised to receive the 23vPPV during pregnancy ( n =?75; 30–36?weeks gestation), at birth ( n =?75), or at 7?months post-partum ( n =?77). Randomisation was stratified by community of residence. In a secondary analysis, we compared the incidence of ALRI hospitalisations and ALRI clinic presentations (ascertained from electronic medical records) among infants of pregnancy vaccinees versus infants of mothers not vaccinated in pregnancy (controls) in the first year of life. Results ALRI hospitalisation incidence was 12.3 per 100 child-years among infants of pregnancy vaccinees compared with 15.8 per 100 child-years among controls (hazard ratio (HR) 0.77, 95%CI 0.29–2.03). ALRI hospitalisations were more common among remote compared to urban infants (27.7 versus 8.6 per 100 child-years). Stratification by dwelling highlighted a differential antenatal vaccine effect against ALRI hospitalisations ( urban HR 2.45, 95%CI 0.60–9.99; remote HR 0.21, 95%CI 0.04–1.08). ALRI clinic presentation incidence was similar among infants of pregnancy vaccinees and controls. Conclusions In this small study, antenatal 23vPPV vaccination was not associated with a reduced incidence of infant ALRI hospitalisations or ALRI clinic presentations during the first year of life. A potential differential effect between urban and remote settings warrants further investigation. Trial registration PneuMum; ClinicalTrials.gov NCT00714064 .
机译：背景技术在澳大利亚北部地区的土著儿童在出生的几周内被肺炎球菌致密地定居，这是由于急性下呼吸道感染（ALRI）的高流行所致。在这种情况下，我们评估了23价肺炎球菌多糖疫苗（23vPPV）对孕妇ALRI的影响。方法在澳大利亚北部地区进行的一项开放标签，分配隐蔽，结果评估者盲法，随机对照试验中，将17-39岁的健康土著妇女在怀孕期间随机接受23vPPV（n =？75; 30-孕36周），分娩时（n = 75）或产后7个月（n = 77）。随机化按居住社区分层。在第二项分析中，我们比较了出生后第一年的怀孕疫苗婴儿与未接种疫苗的母亲婴儿（对照）之间的ALRI住院和ALRI临床表现（从电子病历确定）的发生率。结果妊娠疫苗婴儿的ALRI住院发生率为每100个孩子年12.3岁，而对照组为每100个孩子年15.8岁（危险比（HR）0.77，95％CI 0.29–2.03）。与城市婴儿相比，偏远地区的ALRI住院更为普遍（每100个儿童年27.7比8.6）。按住所分层显示针对ALRI住院的产前疫苗效果不同（城市HR 2.45，95％CI 0.60–9.99;偏远HR 0.21，95％CI 0.04–1.08）。在怀孕的疫苗接种婴儿和对照组中，ALRI临床表现发生率相似。结论在这项小型研究中，产前23vPPV疫苗接种与出生后第一年婴儿ALRI住院或ALRI临床表现减少的发生率无关。城市和偏远地区之间的潜在差异影响值得进一步研究。试用注册PneuMum; ClinicalTrials.gov NCT00714064。

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