23价肺炎球菌多糖疫苗在澳大利亚北领地孕期接种对婴儿急性下呼吸道感染的影响。
Impact of the 23-valent pneumococcal polysaccharide vaccination in pregnancy against infant acute lower respiratory infections in the Northern Territory of Australia.
作者信息
Binks Michael J, Moberley Sarah A, Balloch Anne, Leach Amanda J, Nelson Sandra, Hare Kim M, Wilson Cate, Nelson Jane, Morris Peter S, Ware Robert S, Tang Mimi L K, Torzillo Paul J, Carapetis Jonathan R, Mulholland Kim, Andrews Ross M
机构信息
1Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory 0810 Australia.
2Murdoch Children's Research Institute, University of Melbourne, Royal Children's Hospital, Melbourne, Victoria Australia.
出版信息
Pneumonia (Nathan). 2018 Dec 25;10:13. doi: 10.1186/s41479-018-0057-2. eCollection 2018.
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 ( = 75; 30-36 weeks gestation), at birth ( = 75), or at 7 months post-partum ( = 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 ( HR 2.45, 95%CI 0.60-9.99; 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.
背景
澳大利亚北领地的原住民儿童在出生几周内就被肺炎球菌大量定植，这是导致急性下呼吸道感染（ALRI）高发的原因。我们评估了孕期接种23价肺炎球菌多糖疫苗（23vPPV）对该地区婴儿ALRI的影响。
方法
在澳大利亚北领地进行的一项开放标签、分配隐藏、结局评估者盲法的随机对照试验中，将17 - 39岁的健康原住民女性随机分为三组，分别在孕期（n = 75；妊娠30 - 36周）、出生时（n = 75）或产后7个月（n = 77）接种23vPPV。随机分组按居住社区进行分层。在一项二次分析中，我们比较了孕期接种疫苗的母亲所生婴儿与未在孕期接种疫苗的母亲所生婴儿（对照组）在生命第一年中ALRI住院率和ALRI门诊就诊率（通过电子病历确定）。
结果
孕期接种疫苗的母亲所生婴儿的ALRI住院率为每100儿童年12.3例，而对照组为每100儿童年15.8例（风险比（HR）0.77，95%置信区间0.29 - 2.03）。与城市婴儿相比，偏远地区婴儿的ALRI住院更为常见（每100儿童年分别为27.7例和8.6例）。按居住类型分层显示，产前疫苗对ALRI住院有不同的影响（HR 2.45，95%置信区间0.60 - 9.99；HR 0.21，95%置信区间0.04 - 1.08）。孕期接种疫苗的母亲所生婴儿和对照组婴儿的ALRI门诊就诊率相似。
结论
在这项小型研究中，产前接种23vPPV与生命第一年婴儿ALRI住院率或ALRI门诊就诊率降低无关。城市和偏远地区之间潜在的差异效应值得进一步研究。
试验注册
PneuMum；美国国立医学图书馆临床试验注册中心NCT00714064。
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