Serological and functional impact of COVID-19 vaccination on the maternal fetal unit and infant immunity

COVID-19 疫苗接种对母婴单位和婴儿免疫力的血清学和功能影响

• 批准号: 10539649
• 负责人: Elke BergmannLeitner
• 金额: $ 22.58万
• 依托单位: THOMAS JEFFERSON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10539649
• 关键词: 2019-nCoV; Antibodies; Antibody Response; Antibody-mediated protection; Biological; Biological Assay; Blood; Breast Feeding; COVID-19; COVID-19 booster; COVID-19 impact; COVID-19 pandemic; COVID-19 vaccination; COVID-19 vaccine; Characteristics; Clinical Research; Cohort Studies; Communicable Diseases; Coronavirus; Data; Data Analyses; Data Analytics; Discipline of obstetrics; Disease; Dose; Evaluation; Evolution; Frequencies; Future; Gestational Age; Guidelines; Health; Hospitals; Human Milk; Immune; Immune response; Immunity; Immunology; Impact evaluation; Infant; Infection; Knowledge; Lactation; Life; Light; Machine Learning; Maternal antibody; Maternal-fetal medicine; Maternally-Acquired Immunity; Measures; Mediating; Methods; Mothers; Neonatal; Neonatology; Nucleoproteins; Outcome; Passive Immunity; Patients; Phase I Clinical Trials; Physiology; Populations at Risk; Postpartum Period; Pregnancy; RNA vaccine; Research; Role; SARS-CoV-2 antibody; SARS-CoV-2 exposure; SARS-CoV-2 immunity; SARS-CoV-2 infection; SARS-CoV-2 spike protein; Sampling; Secondary Immunization; Serology; Seroprevalences; Serum; Specialist; Specificity; Time; Treatment Efficacy; Umbilical Cord Blood; Urban Hospitals; Vaccination; Vaccine Clinical Trial; Vaccine Research; Vaccines; Vertical Disease Transmission; Virulent; Woman; acquired immunity; arm; base; biomarker identification; booster vaccine; cohort; coronavirus disease; cross reactivity; experience; fetal; high dimensionality; interest; maternal serum; maternal vaccination; neonatal immunity; neonate; novel; potential biomarker; pregnant; response; translational study; transmission process; vaccination protocol; vaccine evaluation; vaccine response; vaccine trial; working group

PROJECT SUMMARY As COVID-19 pandemic continues with the evolution of new strains, we acknowledge the groundwork that has been done evaluating maternal immunity following COVID-19 vaccine or disease exposure in pregnancy, and passive transmission of antibodies in cord blood and breastmilk. There remains a significant knowledge gap at this time relating to first, the impact of booster vaccination on maternal immunity in pregnancy and lactation taking into consideration new strains, and second an understanding of the strength and durability of passively acquired infant immunity through evaluation of infant serology following maternal vaccination in pregnancy or breastfeeding. This knowledge gap has become even more significant in light of the recently started widespread administration of COVID vaccines and now booster doses to pregnant and breastfeeding women and new virulent strains. The impact of COVID-19 vaccination on the maternal-fetal unit needs to be assessed by profiling maternal serologic and immunologic response to vaccination during pregnancy and post partum, and expanding on assessment of breastmilk and cordblood with infant serological studies as well. We propose a multi arm cohort study to carry out a comprehensive evaluation of the impact of COVID-19 booster dose, initial vaccine, and COVID-19 disease on the maternal fetal unit and post-natal infant immunity. This immunoprofiling effort will provide a valuable characterization of humorally mediated immunity in both mother and infant that that can guide clinical vaccine trials and protocols in pregnancy, identify potential neonatal benefits from passive immunity, and inform timing of infant vaccination. The COVID-19 pandemic has prompted the rapid initiation of immunoprofiling studies, but ours is unique: 1) Unlike studies to date we will evaluate longitudinal infant immunity to examine the functional immunity gained from maternal vaccine exposures 2) We are building on an existing cohort of pregnant and lactating women exposed to COVID-19 disease and an initial mRNA vaccine course, as well as banked control samples, to allow for multiple comparison in evaluating immune correlates of vaccine/booster in pregnancy or lactation 3) by using highly dose-sparing, multiplex electroluminescence-based assays, it will characterize a wide range of antibody characteristics of SARS-CoV2 infection and vaccination to characterize the change in serological and functional SARS CoV2 immune profile in mother and neonate following COVID- 19 vaccine and booster exposure 4) by assessing paired maternal, cordblood, breastmilk, and infant blood we will study the role of timing of exposure and maternal on long term neonatal and infant functional immunity; 5) we will use machine-learning to identify predictive correlates of SARS-CoV2 immunity that could help guide vaccine research to maximize maternal and neonatal immunity.

项目摘要 随着Covid-19-19的大流行在新菌株的演变中继续，我们承认 已经完成了COVID-19-19疫苗或怀孕期间疾病暴露后的孕产妇免疫力，以及 脐带血和母乳中抗体的被动传播。仍然存在很大的知识差距 这次是关于首先，加强疫苗接种对孕妇免疫的影响 考虑到新的菌株，其次是对被动的强度和耐用性的理解 通过评估孕妇疫苗接种后，通过评估婴儿血清学或 哺乳。鉴于最近开始的广泛启动，这种知识差距变得更加显着 给予孕妇和母乳喂养的妇女和新的疫苗，现在加强剂量 强烈的菌株。 COVID-19疫苗接种对母亲娱乐单位的影响需要通过分析来评估 孕产妇的血清学和免疫学反应对怀孕和摄影期间的疫苗接种，并扩大 在评估母乳和山脉时，还通过婴儿血清学研究。我们提出了一个多臂队列 对COVID-19-Booster剂量，初始疫苗和 孕产妇胎儿单位和产后婴儿免疫的Covid-19疾病。这种免疫专长的工作将 提供可以指导的母亲和婴儿的幽默介导的免疫的有价值的特征 怀孕中的临床疫苗试验和方案，确定被动免疫的潜在新生儿益处， 告知婴儿疫苗接种的时间。 COVID-19大流行促使免疫促进迅速启动 研究，但我们的独特之处：1）与迄今为止的研究不同，我们将评估纵向婴儿免疫以检查 从母体疫苗暴露中获得的功能免疫力2）我们正在现有的孕妇中建立 和暴露于199疾病的妇女和初始mRNA疫苗课程，以及 对照样品，以评估疫苗/增强剂中的免疫相关性进行多次比较 怀孕或哺乳3）通过使用高剂量的基于多重电致电测定法，它将 表征SARS-COV2感染和疫苗接种的广泛抗体特征以表征 在COVID- 19疫苗和助推器暴露4）通过评估配对的母体，山脉，母乳和婴儿血液 将研究暴露和母体时间对长期新生儿和婴儿功能免疫的作用； 5） 我们将使用机器学习来识别可以帮助指导的SARS-COV2免疫的预测相关性 疫苗研究以最大化母体和新生儿免疫。