Optimization of Antibiotics in Mothers and their Breastfed Infants Using Pharmacomicrobiomic and Metabolomic Analyses

项目摘要/摘要 孕妇特别容易感染SARS-CoV-2，并有可能患上更严重的或 病程复杂，包括死亡风险增加约70%。妊娠期间的感染也会出现 与早产风险增加以及其他不良妊娠结局有关，例如 死产。因此，孕妇被认为是优先接种疫苗的人群。中的限制 现有孕妇临床试验的设计和V-SAFE注册中缺乏对照组 指出迫切需要按疫苗暴露三个月提供额外的疫苗安全性和有效性数据，并 包括孕妇和他们的后代相对于 未暴露对照组。向家长奖1P50HD106463-01提供行政补充资金和 利用加州大学圣地亚哥分校已建立的美国母婴怀孕队列研究，我们建议完成 新登记和跟踪900名新冠肺炎疫苗暴露者(所有品牌、所有剂量、所有三个月 )和900个未接种疫苗的对照指标，以评估妊娠结局，包括重大先天性 畸形、自然流产、死产、早产、小于胎龄儿、出生后 通过一年的年龄增长。此外，通过产后一年的时间，我们将比较 孕期接种SARS-CoV-2的母婴对接种后感染情况分析 孕期未接种疫苗的母婴配对感染发生率。 最后，在180名接种疫苗的人(每三个月接触60人)的子集中，代表暴露于以下一种 我们将在孕期最后一次接种疫苗后采集血液样本 以检查怀孕期间的免疫反应。这些数据将提供必要的安全性和有效性 能够支持新冠肺炎疫苗相关公共卫生建议的信息。

Project Summary/Abstract Pregnant people are particularly vulnerable to SARS-CoV-2 and at risk of developing a more serious or complicated disease course, including about a 70% increased risk of death. Infection in pregnancy also appears to be related to increased risk for preterm delivery as well as other adverse pregnancy outcomes, such as stillbirth. For this reason, pregnant people are considered a priority population for vaccination. Limitations in the design of existing clinical trials with pregnant persons and the lack of a comparison group in the V-Safe Registry point to the urgent need for additional vaccine safety and efficacy data by trimester of vaccine exposure and encompassing both short and longer term outcomes for pregnant people and their offspring relative to an unexposed comparison group. With administrative supplement funding to parent award 1P50HD106463-01 and using the established U.S. MotherToBaby pregnancy cohort study at UC San Diego, we propose to complete new enrollment and follow-up of 900 COVID-19 vaccine exposed individuals (all brands, all doses, all trimesters of exposure) and 900 unvaccinated comparators to evaluate pregnancy outcomes including major congenital malformations, spontaneous abortion, stillbirth, preterm delivery, small for gestational age infants, postnatal growth through one year of age. In addition, through one year post-partum we will compare the incidence of SARS-CoV-2 infection post-vaccination in maternal/child pairs who were vaccinated in pregnancy to the incidence of infection in gestational-age matched maternal/child pairs who were not vaccinated in pregnancy. Finally, in a subset of 180 vaccinated individuals (60 per trimester of exposure) representing exposure to one of the two mRNA vaccine products we will obtain blood samples following the last vaccination dose in pregnancy in order to examine immune response in pregnancy. These data will provide essential safety and efficacy information that can support COVID-19 vaccine-related public health recommendations in this special population.