Vaccine and Treatment Evaluation Units - DMID 21-0012

总结/摘要 Emory VTEU将参加DMID 21-0012，一项迟发性异位妊娠的I/II期研究 SARS-CoV-2疫苗接种（加强）后接种EUA疫苗。安全知识， SARS-CoV-2延迟同源和异源加强免疫耐受性和免疫原性 在EUA给药方案后， 诱导对变异循环菌株免疫，并提高 保护利用可获得的EUA剂量的COVID-19疫苗（目前为mRNA-1273，mRNA-1274）， BNT 162 b2和AD26.COV2.S），我们建议评估先天性、细胞和体液免疫 利用具有同源性的mRNA，从多个初免-加强组合引起的应答 刺突蛋白作为助推剂，同时寻求避免重复目前正在计划的试验设计 阶段或过程中。这项1/2期研究将评估安全性、耐受性和 SARS-CoV-2疫苗免疫原性研究 健康成年参与者的队列，其中一个接受了EUA疫苗接种，另一个接受了 这是一种疫苗。我们将在收到这些参与者的 延迟升压除筛选和疫苗接种访视外，研究访视将在第2周进行， 接种后1、3、6和12个月，采血用于免疫原性评估。 将使用记忆辅助工具收集征集性不良事件（AE），并记录在 从每次接种时至每次接种后7天，给予适当的DCF。 将在每次接种后28天内收集非征集性AE。28天后， 直至研究结束的末次疫苗接种，仅SAE、方案规定的特殊不良事件 关注的不良事件（AESI）、医学治疗的不良事件（MAAE）和新发医学疾病 （NOCMC）将报告为AE。该研究将在两个埃默里VTEU进行 地点：埃默里儿童中心（ECC-VRC）和希望诊所。招募和登记将 在这两个地方都发生了。埃默里VTEU已证明在抗击这一流行病方面至关重要。这 补充将允许对研究疫苗剂量加强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