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.

项目总结 这是一项旨在收集临床信息的观察性、非干预性、前瞻性队列研究。 和样本来评估大约2,000项研究的免疫反应 产妇接种许可或EUA SARS-CoV-2疫苗后的参与者。怀孕了， 产后个人及其婴儿将接受学习兴趣和资格筛查，并 已注册。研究参与者小组如下： 大约2,000名研究参与者将被登记到四个受试组中的一个： 第1组：感染严重急性呼吸系统综合症冠状病毒(-CoV-2)的人士 2)怀孕期间接种疫苗(每种疫苗类型最多150人) 第2组：产后接种-CoV-2疫苗的个人(每种疫苗最多50人 类型) 第3组：孕期接种疫苗的婴儿(每名婴儿约150名 疫苗类型) 第4组：产后接种疫苗的婴儿(每种疫苗约50名婴儿 类型) 主要目标是： ·免疫原性：描述母体血清抗体在收到 孕期接种SARS-CoV-2疫苗的个体，按疫苗类型和平台分类。 ·免疫原性：描述SARS-CoV-2抗体经胎盘转移的情况 在怀孕期间接种的个人，总体上，按疫苗类型和平台进行接种。 ·免疫原性：描述婴儿血清SARS-CoV-2抗体的动力学和持久性 母亲在孕期接种疫苗，按疫苗类型和接种平台分列。