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Dengue vaccination during pregnancy – An overview of clinical trials data

机译：怀孕期间登革热疫苗 - 临床试验数据的概述

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BackgroundThe live, attenuated, tetravalent dengue vaccine (CYD-TDV) is licensed in several endemic countries and contraindicated during pregnancy. Inadvertent vaccination during pregnancy may occur during clinical trials that include women of childbearing age. The potential risk associated with dengue vaccination in pregnancy remains unknown. We describe pregnancy outcomes following inadvertent dengue vaccination in pregnancy from CYD-TDV trial data.MethodsData were collected from trials conducted as part of the CYD-TDV clinical development. Women who received CYD-TDV or placebo during the pre-specified pregnancy risk window (from 30?days before the date of their last menstrual period to end of pregnancy) were considered as exposed; pregnancies occurring in non-risk periods during the trials were considered to be non-exposed. Pregnancy losses were defined as abortion (spontaneous or unspecified), death in utero, and stillbirth.Results615 pregnancies were reported from 19 CYD-TDV trials: 404 in the CYD-TDV arm, and 211 in the placebo arm. Exposure could not be determined for 7 pregnancies (5, CYD-TDV; 2, placebo). In the CYD-TDV arm, 58 pregnancies were considered as exposed. Most of these (n?=?47, 81%) had healthy live births; 6 (10.3%) had pregnancy losses; 3 underwent elective termination and 2 had unknown outcome. In the placebo group, 30 pregnancies were considered exposed. Most of these (n?=?25, 83%) had healthy births; 4 (13.3%) had pregnancy losses; and 1 had elective termination. Among non-exposed pregnancies, most resulted in healthy live births; 23/341 (6.7%) in the CYD-TDV group and 17/179 (9.5%) in the placebo group had pregnancy losses. Most reported pregnancy losses were in women considered high-risk for adverse pregnancy outcome, primarily due to young age.ConclusionIn the small dataset assessed, no evidence of increased adverse pregnancy outcomes has been identified from inadvertent immunization of women in early pregnancy with CYD-TDV compared with the control group.
机译：背景：减毒活，四价疫苗登革热（CYD-TDV）在几个流行国家授权和孕期禁忌。在临床试验，其中包括育龄妇女，可能会出现在怀孕期间不慎接种。妊娠合并登革热疫苗接种有关的潜在风险仍是未知。我们描述了从作为CYD-TDV临床开发的一部分进行的试验收集以下从CYD-TDV试验data.MethodsData怀孕不慎登革热疫苗接种妊娠结局。 （？他们的最后一次月经怀孕的结束日期前30天）谁预先指定的怀孕风险窗口期间接受CYD-TDV或安慰剂的妇女被认为是暴露;在试验期间非风险时段发生妊娠被认为是未曝光。在安慰剂组中CYD-TDV臂404和211：在怀孕的损失被定义为在子宫内的流产（自发或不指定），死亡和从19 CYD-TDV试验报道stillbirth.Results615怀孕。曝光无法为7名怀孕（; 2，安慰剂5，CYD-TDV）来确定。在CYD-TDV手臂，58周妊娠被视为曝光。大多数这些（N = 47，81％？）有健康的活产; 6（10.3％）有妊娠损失; 3行选择性终止和2有未知的结果。在安慰剂组中，30名怀孕被认为是暴露。大多数的这些（？N = 25，83％）有健康胞胎; 4（13.3％）有妊娠损失; 1例选择终止。在非暴露怀孕，最引起健康活产; 341分之23（6.7％），安慰剂组中的CYD-TDV组和一百七十九分之一十七（9.5％）中有怀孕损失。报道最多的怀孕损失是在被认为高风险的不良妊娠结局，主要是由于年轻age.ConclusionIn小数据集进行评估，不会增加不良妊娠结局的证据已经从女性的不慎免疫标识在怀孕初期与CYD-TDV女性与对照组相比较。

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