Vaccine and Treatment Evaluation Units - DMID 21-0012

疫苗和治疗评估装置 - DMID 21-0012

• 批准号: 10407815
• 负责人: EVAN J ANDERSON
• 金额: $ 116.98万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-08 至 2025-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10407815
• 关键词: 2019-nCoV; Adult; Adverse event; Blood; COVID-19 vaccine; Child; Clinic; Collection; Dose; Enrollment; Evaluation; Immune response; Immunity; Investigation; Knowledge; Medical; Memory; Messenger RNA; Moderna COVID-19 vaccine; Participant; Pfizer-BioNTech COVID-19 vaccine; Phase; Process; Proteins; Protocols documentation; Regimen; Reporting; Safety; Schedule; Site; Special Event; Specific qualifier value; Time; Vaccination; Vaccines; Variant; Visit; cohort; fight against; immunogenicity; improved; interest; pandemic disease; recruit; screening; trial design; vaccine access; vaccine trial

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

摘要/摘要 Emory VTEU将参与DMID 21-0012，延迟异源基因的1/2期研究 接受EUA疫苗后的SARS-CoV-2疫苗剂量(Boost)。对安全的了解， SARS-CoV-2延迟同源和异源增强的耐受性和免疫原性 在EUA给药方案后接种含有类似或变异尖峰的疫苗可能 诱导对不同的循环菌株的免疫，提高广泛性和持久性 保护。利用现有的欧洲联盟剂量的新冠肺炎疫苗(目前为mRNA1273mRNA. BNT162b2和AD26.COV2.S)，我们建议评估先天免疫、细胞免疫和体液免疫 利用具有同源基因的信使核糖核酸，从多个质数增强组合中引起的反应 添加蛋白质作为助推剂，同时寻求避免重复目前正在规划的试验设计 分阶段或正在进行中。这项1/2期研究将评估安全性、耐受性和 两种延迟同源或异种增强型SARS-CoV-2疫苗的免疫原性 健康的成年参与者队列，其中一人接受了EUA疫苗接种，另一人 这是疫苗的天真。我们将在收到报告后对这些参与者进行为期12个月的跟踪调查 延迟助推器。除了筛查和疫苗接种访问外，研究访问将在2周内进行， 接种后1、3、6和12个月采血进行免疫原性评估。 征求的不良事件(AE)将使用记忆辅助工具收集并记录在 从每次接种之时到每次接种后7天的适当的DCF。 在每次接种疫苗后的28天内，将收集到未经请求的AEs。在发布后28天 最后一次接种疫苗到研究结束时，只有SAE，议定书规定了特殊的不良事件 兴趣(AESIs)、参加医疗的不良事件(MAAE)和新发的医疗状况 (NOCMCs)将被报告为AEs。这项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。招聘和注册将 在两个站点都会发生。事实证明，埃默里VTEU在抗击大流行的斗争中至关重要。这 补充将允许对疫苗试验进行进一步调查，研究疫苗剂量增加。 1