Vaccine and Treatment Evaluation Units - DMID 21-0012

摘要/摘要 埃默里大学 VTEU 将参加 DMID 21-0012，一项延迟异源性的 1/2 期研究 接受 EUA 疫苗后 SARS-CoV-2 疫苗剂量（加强）。安全知识， SARS-CoV-2 延迟同源和异源加强的耐受性和免疫原性 在 EUA 给药方案后加入类似或变体尖峰的疫苗可能会 诱导对变异循环菌株的免疫力，并提高免疫的广度和持久性 保护。利用现有的 EUA 剂量的 COVID-19 疫苗（目前为 mRNA-1273、mRNA- BNT162b2 和 AD26.COV2.S），我们建议评估先天免疫、细胞免疫和体液免疫 利用具有同源性的 mRNA，从多个初免加强组合中引发反应 尖峰蛋白作为增强剂，同时寻求避免重复目前正在规划的试验设计 阶段或进行中。这项 1/2 期研究将评估安全性、耐受性和 两种延迟同源或异源加强 SARS-CoV-2 疫苗的免疫原性 一组健康成年参与者，其中一名接受了 EUA 疫苗接种，另一名接受了 EUA 疫苗接种 这是未接种过疫苗的。我们将在收到这些参与者后 12 个月内对其进行跟踪 延迟升压。除了筛查和疫苗接种访视外，两周后还将进行研究访视， 接种后 1、3、6 和 12 个月采集血液进行免疫原性评估。 将使用记忆辅助工具收集引起的不良事件 (AE) 并记录在 从每次疫苗接种时到每次疫苗接种后 7 天，适当的 DCF。 每次疫苗接种后 28 天内将收集主动提供的 AE。 28 天后 最后一次疫苗接种直至研究结束，仅限 SAE、方案规定的特殊不良事件 兴趣 (AESI)、就医不良事件 (MAAE) 和新发医疗状况 (NOCMC) 将报告为 AE。该研究将在埃默里大学的两个 VTEU 中进行 地点：埃默里儿童中心 (ECC-VRC) 和希望诊所。招聘和招生将 发生在两个站点。事实证明，埃默里大学 VTEU 在抗击这一流行病方面至关重要。这个 补充品将允许对研究疫苗剂量增加的疫苗试验进行进一步调查。 1

Summary/Abstract The Emory VTEU will participate in DMID 21-0012, A Phase 1/2 Study of Delayed Heterologous SARS-CoV-2 Vaccine Dosing (Boost) after Receipt of EUA Vaccines. Knowledge of the safety, tolerability, and immunogenicity of SARS-CoV-2 delayed homologous and heterologous boost vaccine incorporating a similar or variant spike administered following EUA dosing regimens might induce immunity to variant circulating strains and improve upon breadth and durability of protection. Utilizing the EUA-dosed COVID-19 vaccines available (currently mRNA-1273, mRNA- BNT162b2, and AD26.COV2.S), we propose to evaluate innate, cellular, and humoral immune responses elicited from multiple prime boost combinations, utilizing the mRNA with homologous spike protein as a boost while seeking to avoid duplicating trial designs currently in planning stages or in process. This phase 1/2 study will evaluate the safety, tolerability, and immunogenicity of delayed homologous or heterologous boost SARS-CoV-2 vaccines in two cohorts of healthy adult participants, one of which has received EUA vaccinations and one of which is vaccine-naïve. We will follow these participants for 12 months following receipt of the delayed boost. In addition to screening and vaccination visits, study visits will occur at 2 weeks, 1, 3, 6, and 12 months post-vaccination with blood collection for immunogenicity assessments. Solicited adverse events (AEs) will be collected using a memory aid and recorded on the appropriate DCF from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs will be collected through 28 days post each vaccination. And after 28 days post last vaccination through the end of study, only SAEs, Protocol Specified adverse events of special interest (AESIs), medically attended adverse events (MAAEs), and new-onset medical conditions (NOCMCs) will be reported as AEs. The study will be conducted across the two Emory VTEU sites: Emory Children’s Center (ECC-VRC) and Hope Clinic. Recruitment and enrollment will occur at both sites. The Emory VTEU has proven essential in the fight against the pandemic. This supplement will allow for further investigations into vaccines trials studying vaccine dosing boosts. 1