Establishment of the New York University Vaccine and Treatment Evaluation Unit (NYU VTEU) - DMID 21-0012

项目总结 本补充提案概述了新冠肺炎预防网络的科学议程。 研究将在纽约大学VTEU进行。我们将参与实施21世纪DMID议定书- 0012，“A期1/2研究在收到EUA后延迟的异源SARS-CoV-2疫苗剂量(Boost) 疫苗。“这项1/2期研究将评估不同SARS-CoV-2的安全性、耐受性和免疫原性 疫苗接种推迟了12周。这项研究将由两个不同的队列组成： 1.以前接种过EUA疫苗的一群人，他们将接种同源或 同源或异源平台上的异源疫苗毒株；以及 2.一群预期接种EUA标准剂量并将可获得的人 用于快速评估未来某个时间点的异源提振。

PROJECT SUMMARY This supplement proposal outlines the scientific agenda for the COVID-19 Prevention Network (CoVPN) research to be carried out at the NYU VTEU. We will participate in the implementation of in DMID protocol 21- 0012, “A Phase 1/2 Study of Delayed Heterologous SARS-CoV-2 Vaccine Dosing (Boost) after Receipt of EUA Vaccines.” This Phase 1/2 study will evaluate the safety, tolerability, immunogenicity of different SARS-CoV-2 vaccine delayed boost at >12 weeks. This study will be composed of two different cohorts: 1. A cohort of persons previously vaccinated with an EUA vaccine who will be boosted with a homologous or heterologous vaccine strain on a homologous or a heterologous platform; and 2. A cohort of persons who are prospectively vaccinated with EUA standard dosing and who will be available for rapid assessment of a heterologous boost at some point in the future.