Defining the optimal type and timing of COVID-19 vaccine in pregnancy

确定怀孕期间接种 COVID-19 疫苗的最佳类型和时机

• 批准号: 10553715
• 负责人: Ai-ris Yonekura Collier
• 金额: $ 25.94万
• 依托单位: BETH ISRAEL DEACONESS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-01-21 至 2024-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10553715
• 关键词: 2019-nCoV; Address; Affect; Age; Antibodies; Antibody Response; Antibody titer measurement; Blood; Brazil; COVID-19; COVID-19 vaccination; COVID-19 vaccine; Cesarean section; Clinical; Clinical Trials; Critical Illness; Cytomegalovirus; Data; Emergency Situation; Enrollment; Future; Gestational Age; Goals; Health; Human Milk; Hypertension; Immune; Immune response; Immunologics; Immunosuppression; Individual; Infant; Infection; Inflammatory; Influenza; Interferons; Knowledge; Lactation; Late pregnancy; Lead; Maternal antibody; Maternally-Acquired Immunity; Measures; Mechanical ventilation; Mission; Moderna COVID-19 vaccine; Mothers; Neonatal; Newborn Infant; Passive Immunity; Patients; Persons; Pfizer-BioNTech COVID-19 vaccine; Placenta; Postpartum Period; Pregnancy; Premature Birth; Public Health; Publishing; Recommendation; Reporting; Research; Respiratory syncytial virus; Risk; SARS-CoV-2 antibody; SARS-CoV-2 infection; Serious Adverse Event; Signal Transduction; Small for Gestational Age Infant; Streptococcus Group B; T cell response; T-Lymphocyte; Umbilical Cord Blood; United States; United States National Institutes of Health; Vaccinated; Vaccination; Vaccinee; Vaccines; Viral; Viral Vector; Woman; Work; Zika Virus; adverse pregnancy outcome; antibody transfer; arm; cellular development; design; early pregnancy; emerging pathogen; high risk; immunogenicity; implantation; improved; infant death; innovation; maternal immune system; maternal outcome; maternal vaccination; neonatal outcome; neonate; neutralizing antibody; novel vaccines; pathogen; placental transfer; pregnant; prevent; reproductive; trial comparing; vaccination strategy; vaccine development; vaccine efficacy; vaccine evaluation; vaccine platform; vaccine response; vaccine strategy; vaccine-induced antibodies; vaccine-induced immunity

PROJECT SUMMARY/ABSTRACT Pregnant individuals are more likely to require invasive mechanical ventilation or die from complications related to coronavirus disease 2019 (COVID-19) than non-pregnant women. COVID-19 vaccination in pregnancy can prevent the consequences of infection for the mother and provide passive immunity to newborns through placental transfer of vaccine-induced antibodies. The maternal immune system undergoes adaptive changes during pregnancy characterized by both active suppression of immune responses against the developing pregnancy and pro-inflammatory signals to promote healthy implantation and initiate labor. The central hypothesis is that the adaptive immunologic changes in pregnancy lead to differences in the development of vaccine-induced immunity depending on the gestational age at vaccination and/or the vaccine platform used. The overall objective of this proposal is to address important knowledge gaps including limited information regarding cellular immune responses following maternal vaccination, immune responses after vaccination in early pregnancy, and comparison of immunogenicity across different vaccine platforms. The research proposed is innovative because we will use a comprehensive immune profiling approach to quantify functional cellular and antibody responses in order to define the COVID-19 vaccine type and timing that optimizes robust and durable maternal vaccine-induced immunity (Aim 1) and neonatal passive immunity from placental transfer of viral neutralizing antibody (Aim 2). The proposed research is significant because it is expected to provide data to inform clinical recommendations for COVID-19 vaccines in pregnancy to improve maternal and neonatal outcomes. The long-term goal will be to provide preliminary data for a larger study evaluating vaccine efficacy for pregnant individuals and their neonates. The knowledge provided by this proposal will also inform future vaccine development for other important and emerging pathogens in pregnancy.

项目总结/摘要 孕妇更可能需要有创机械通气或死于相关并发症 与非孕妇相比，2019年冠状病毒病（COVID-19）的发病率更高。怀孕期间接种COVID-19疫苗可以 预防母亲感染的后果，并通过以下方式为新生儿提供被动免疫力 胎盘转移疫苗诱导的抗体。母体免疫系统经历适应性变化 在怀孕期间，其特征是对发育中的 妊娠和促炎信号，以促进健康的植入和启动分娩。中央 一种假说认为，妊娠期的适应性免疫变化导致了 疫苗诱导的免疫力取决于接种时的胎龄和/或所用的疫苗平台。 本提案的总体目标是填补重要的知识空白，包括有限的信息 关于母体接种疫苗后的细胞免疫应答， 早期妊娠，以及不同疫苗平台的免疫原性比较。研究提出， 是创新的，因为我们将使用一种全面的免疫分析方法来量化功能性细胞， 抗体反应，以确定COVID-19疫苗类型和时间，优化稳健和持久的 母体疫苗诱导的免疫（目的1）和新生儿从病毒胎盘转移的被动免疫 中和抗体（Aim 2）。这项拟议中的研究意义重大，因为它有望为以下方面提供数据： 为孕妇接种COVID-19疫苗提供信息化临床建议，以改善孕产妇和新生儿 结果。长期目标将是为评估疫苗效力的更大规模研究提供初步数据 孕妇及其新生儿的安全。该提案提供的知识也将告知未来 针对妊娠期其他重要和新出现病原体的疫苗开发。