三价流感疫苗接种孕妇随机对照试验与不良胎儿结局。
Trivalent influenza vaccination randomized control trial of pregnant women and adverse fetal outcomes.
机构信息
Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, York Road, Parktown, Johannesburg 2193, South Africa; Colorado School of Public Health, Center for Global Health, University of Colorado School of Medicine, Aurora Colorado, 13123 E. 16(th) Ave., B055 Aurora, CO, United States; University of Colorado Denver, Dept. of Pediatric Infectious Diseases, 13123 E. 16(th) Ave, B055 Aurora, CO, United States.
Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, York Road, Parktown, Johannesburg 2193, South Africa; Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, York Road, Parktown, Johannesburg 2193, South Africa.
出版信息
Vaccine. 2019 Aug 23;37(36):5397-5403. doi: 10.1016/j.vaccine.2019.07.024. Epub 2019 Jul 19.
INTRODUCTION
The purpose of this study was to evaluate the association of influenza vaccine during pregnancy and adverse fetal outcomes. Preventing fetal death, low birth weight, small for gestational age birth and preterm birth are important potential effects of antenatal maternal influenza immunization for which there are conflicting data.
MATERIALS AND METHODS
A double-blind, randomized, placebo-controlled clinical trial of trivalent inactivated influenza vaccine was conducted in South Africa from March 2011 until after the 2012 influenza season when the infants born had reached the age of 24 weeks. Mothers were administered the vaccine or placebo during pregnancy at a gestation of 20 to 36 weeks. A comparison of rates of fetal death, low birth weight, small for gestational age birth, and preterm birth, between vaccinated and placebo groups was made. Fetal outcome differences between the groups were measured using Student's t-tests, vaccine efficacy with 95% confidence intervals, and Poisson regression for incidence rates. All analyses except fetal death excluded mothers who were administered vaccine or placebo after 34 weeks gestational age.
RESULTS
There were 2116 HIV-uninfected pregnant women age 18 to 38 years in the trial; 2005 infants were born to mothers where vaccine or placebo had been administered ≥ 14 days prior to delivery, and there were 6 miscarriages and 23 stillbirths. There was no significant vaccine efficacy (with [95% confidence interval]) on fetal death (-21.2% [-150.8, 41.4]), low birth weight (-11.1% [-42.3, 12.5]), small for gestational age birth (-9.9% [-35.6, 11.0]), or preterm birth (-21.3% [-60.5, 8.3]). Neither was vaccine efficacy demonstrated when the analysis was restricted to infants of mothers who were exposed to an influenza season (1832 outcomes available).
CONCLUSION
We did not find a beneficial effect of trivalent inactivated influenza vaccine during pregnancy on adverse fetal outcomes.
引言
本研究旨在评估孕妇接种流感疫苗与不良胎儿结局的关联。预防胎儿死亡、低出生体重、小于胎龄儿和早产是产前母体流感免疫的重要潜在影响，但目前相关数据存在冲突。
材料与方法
2011 年 3 月至 2012 年流感季节后，在南非开展了一项三价灭活流感疫苗的双盲、随机、安慰剂对照临床试验，当时出生的婴儿已达到 24 周龄。孕妇在妊娠 20 至 36 周时接种疫苗或安慰剂。比较疫苗组和安慰剂组的胎儿死亡、低出生体重、小于胎龄儿和早产发生率。采用学生 t 检验、疫苗效力（95%置信区间）和泊松回归分析发病率比较两组间胎儿结局差异。除了将在妊娠 34 周后接受疫苗或安慰剂的母亲排除在外，所有分析均排除了母亲在分娩前 14 天内接种疫苗或安慰剂。
结果
试验共纳入 2116 例年龄在 18 至 38 岁的 HIV 阴性孕妇；2005 例婴儿的母亲在分娩前 14 天内接受了疫苗或安慰剂治疗，其中有 6 例流产和 23 例死胎。疫苗在胎儿死亡（-21.2% [-150.8, 41.4]）、低出生体重（-11.1% [-42.3, 12.5]）、小于胎龄儿（-9.9% [-35.6, 11.0]）和早产（-21.3% [-60.5, 8.3]）方面均无显著疗效。当分析仅限于暴露于流感季节的母亲所生婴儿（1832 例）时，也未发现疫苗有疗效。
结论
我们未发现孕妇接种三价灭活流感疫苗对不良胎儿结局有有益影响。
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