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.

项目概要 随着新毒株的不断进化，COVID-19 大流行仍在继续，我们承认已经做好的基础工作 已评估过接种 COVID-19 疫苗或怀孕期间接触疾病后的母体免疫力，以及 脐带血和母乳中抗体的被动传播。仍存在显着的知识差距 这次涉及第一，加强疫苗接种对孕期和哺乳期母体免疫力的影响 考虑到新的应变，其次了解被动的强度和耐久性 通过在怀孕或母亲接种疫苗后评估婴儿血清学获得婴儿免疫力 哺乳。鉴于最近开始广泛传播，这种知识差距变得更加严重 向孕妇和哺乳期妇女以及新冠肺炎疫苗和现在的加强剂量注射 强毒株。需要通过分析来评估 COVID-19 疫苗接种对母胎单位的影响 孕期和产后母亲对疫苗接种的血清学和免疫反应，并扩大 还通过婴儿血清学研究评估母乳和脐带血。我们提出了一个多臂队列 研究对 COVID-19 加强剂量、初始疫苗和疫苗的影响进行全面评估 COVID-19 疾病对母胎单位和产后婴儿免疫力的影响。这项免疫分析工作将 提供了母亲和婴儿体液介导的免疫的有价值的特征，可以指导 妊娠期临床疫苗试验和方案，确定被动免疫对新生儿的潜在益处，以及 告知婴儿疫苗接种的时间。 COVID-19 大流行促使免疫分析迅速启动 研究，但我们的研究是独一无二的：1）与迄今为止的研究不同，我们将评估纵向婴儿免疫力以检查 从母体疫苗暴露中获得的功能性免疫力 2) 我们正在现有的孕妇队列的基础上建立 暴露于 COVID-19 疾病的哺乳期妇女和初始 mRNA 疫苗疗程，以及库存 对照样本，以便在评估疫苗/加强疫苗的免疫相关性时进行多重比较 怀孕或哺乳期 3) 通过使用高度节约剂量、基于多重电致发光的检测，它将 表征 SARS-CoV2 感染和疫苗接种的广泛抗体特征 COVID-19 后母亲和新生儿血清学和功能性 SARS CoV2 免疫谱的变化 19 疫苗和加强接种 4) 通过评估配对母血、脐带血、母乳和婴儿血液，我们 将研究暴露时间和母亲对新生儿和婴儿长期功能免疫的作用； 5） 我们将使用机器学习来识别 SARS-CoV2 免疫的预测相关性，这可以帮助指导 疫苗研究以最大限度地提高孕产妇和新生儿的免疫力。