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

基本信息

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
项目类别：
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

项目摘要

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.

项目摘要/摘要孕妇更有可能需要侵入性的机械通气或死于并发症相关的并发症与非妊娠女性相比，2019年冠状病毒病（Covid-19）。 COVID-19怀孕的疫苗接种可以防止母亲感染的后果，并通过疫苗诱导的抗体的胎盘转移。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免疫反应进行主动抑制怀孕和促炎信号，以促进健康的植入并开始劳动。中央假设是怀孕的适应性免疫学变化导致疫苗诱导的免疫力取决于疫苗接种和/或所使用的疫苗平台时的免疫力。该提案的总体目的是解决重要的知识差距，包括有限的信息关于母体疫苗接种后的细胞免疫反应，疫苗接种后的免疫反应早期怀孕以及在不同疫苗平台上的免疫原性的比较。研究提出了具有创新性，因为我们将使用全面的免疫分析方法来量化功能性细胞和抗体反应以定义优化健壮耐用的covid-19疫苗类型和时机母体疫苗诱导的免疫力（AIM 1）和新生儿被动免疫，可免疫病毒的胎盘转移中和抗体（AIM 2）。拟议的研究很重要，因为它有望提供数据为妊娠中的Covid-19疫苗提供临床建议，以改善母亲和新生儿结果。长期目标是为评估疫苗功效的更大研究提供初步数据适用于怀孕的人及其新生儿。该提案提供的知识也将为未来提供信息妊娠中其他重要和新兴病原体的疫苗开发。