Establishment of the New York University Vaccine and Treatment Evaluation Unit (NYU VTEU) – DMID 21-0004

纽约大学疫苗和治疗评估单位 (NYU VTEU) 成立 — DMID 21-0004

• 批准号: 10416210
• 负责人: Mark Joseph Mulligan
• 金额: $ 62.54万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-06-29 至 2023-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10416210
• 关键词: 2019-nCoV; Antibodies; COVID-19 vaccine; Clinical; Eligibility Determination; Enrollment; Evaluation; Immune response; Individual; Infant; Kinetics; Mothers; New York; Participant; Postpartum Period; Pregnancy; Prospective cohort study; Research Design; SARS-CoV-2 antibody; Serum; Specimen; Universities; Vaccinated; Vaccines; antibody transfer; immunogenicity; interest; maternal serum; pregnant

PROJECT SUMMARY This is an observational, non-interventional, prospective cohort study designed to collect clinical information and specimens to evaluate the immune responses from approximately 2,000 study participants following maternal receipt of licensed or EUA SARS-CoV-2 vaccines. Pregnant and postpartum individuals and their infants will be screened for study interest and eligibility and enrolled. Study participant groups are as follows: Approximately 2,000 study participants will be enrolled into one of four subject groups:  Group 1: Individuals who receive a Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV- 2) vaccine during pregnancy (up to150 individuals per vaccine type)  Group 2: Individuals who receive a SARS-CoV-2 vaccine postpartum (up to 50 individuals per vaccine type)  Group 3: Infants of individuals who receive vaccine during pregnancy (approximately 150 infants per vaccine type)  Group 4: Infants of individuals who receive vaccine postpartum (approximately 50 infants per vaccine type) Primary objectives are: • Immunogenicity: To describe the kinetics and durability of maternal serum antibodies following receipt of SARS-CoV-2 vaccine in individuals vaccinated during pregnancy, by vaccine type and platform. • Immunogenicity: To describe the transplacental antibody transfer of SARS-CoV-2 antibodies among individuals vaccinated during pregnancy, overall and by vaccine type and platform. • Immunogenicity: To describe the kinetics and durability of serum SARS-CoV-2 antibodies in infants of mothers vaccinated during pregnancy, by vaccine type and platform.

项目摘要 这是一项旨在收集临床信息的观察性，非介绍性的前瞻性队列研究 和标本以评估大约2,000项研究的免疫复杂 收到许可或EUA SARS-COV-2疫苗后的参与者。怀孕和 产后个人及其婴儿将被筛选以进行研究兴趣和资格，以及 注册。研究参与者小组如下： 大约有2,000名研究参与者将被招募成四个学科组之一： 第1组：接受严重急性呼吸综合征冠状病毒2的个人（SARS-COV- 2）怀孕期间的疫苗（每种疫苗类型高达150个人） 第2组：接受SARS-COV-2疫苗产后的个人（每疫苗最多50个人 类型） 第3组：怀孕期间接受疫苗的个体婴儿（大约150个婴儿 疫苗类型） 第4组：接受产后疫苗的个体婴儿（每疫苗约50名婴儿） 类型） 主要目标是： •免疫原性：描述收到母体血清抗体的动力学和耐用性 通过疫苗类型和平台，在怀孕期间接种疫苗的个体中的SARS-COV-2疫苗。 •免疫原性：描述SARS-COV-2抗体的移植抗体转移 在怀孕期间，总体以及疫苗类型和平台接种疫苗的个体。 •免疫原性：描述婴儿的动力学和耐用性 母亲在怀孕期间通过疫苗类型和平台接种疫苗。