CoVPN 3006: A randomized controlled study to assess SARS-CoV-2 infection, viral shedding, and subsequent potential transmission in university students immunized with Moderna COVID-19 Vaccine

CoVPN 3006：一项随机对照研究，旨在评估接种 Moderna COVID-19 疫苗的大学生中的 SARS-CoV-2 感染、病毒脱落以及随后的潜在传播

• 批准号: 10375264
• 负责人: Peter B. Gilbert
• 金额: $ 203.47万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH CENTER
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-03 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10375264
• 关键词: 2019-nCoV; Address; Adult; Biological Assay; Biometry; COVID-19; COVID-19 Prevention Network; COVID-19 outbreak; COVID-19 pandemic; COVID-19 severity; COVID-19 testing; COVID-19 vaccine; Cellular Assay; Clinical; Clinical Trials; Clinical Trials Network; Cohort Studies; Communicable Diseases; Constitution; Coronavirus; Country; Development; Diagnosis; Disease; Emergency Situation; End Point Assay; Event; Eye; Future; Goals; HIV Vaccine Trials Network; HIV vaccine; Health; Immune; Immune response; Immunity; Immunize; Immunologic Monitoring; Immunology; Incidence; Individual; Infection; Infection Control; Infection prevention; International; Knowledge; Laboratories; Lead; Leadership; Malaria; Measures; Mediating; Messenger RNA; Moderna COVID-19 vaccine; Monitor; Morbidity - disease rate; Nose; Participant; Persons; Pharmaceutical Preparations; Phase; Physicians; Population; Preparation; Prevention; Procedures; Protocols documentation; Proxy; Quality Control; Randomized; Randomized Clinical Trials; Research Methodology; Risk; SARS-CoV-2 infection; SARS-CoV-2 positive; SARS-CoV-2 transmission; Sampling; Scientist; Serology test; Severe Acute Respiratory Syndrome; Site; Symptoms; System; Typhoid Fever; United States; United States National Institutes of Health; Universities; Vaccinated; Vaccination; Vaccines; Validation; Viral; Viral Load result; Virus Shedding; aged; arm; clinical efficacy; clinical trial analysis; cohort; design; diaries; efficacy evaluation; efficacy study; efficacy trial; experience; follow-up; healthy volunteer; immune function; immunogenicity; improved; infection rate; mortality; nasal swab; operation; prevent; programs; prospective; quality assurance; randomized controlled study; recruit; response; seropositive; transmission process; university student; vaccine efficacy; vaccine evaluation; vaccine trial; volunteer

Project Abstract This proposal outlines the scientific agenda for the COVID-19 Prevention Network (CoVPN) Vaccines Leadership Operations Center (LOC) for implementation of the COVID-19 vaccine trial entitled “A randomized controlled study to assess SARS-CoV-2 infection, viral shedding, and subsequent potential transmission in university students immunized with Moderna COVID-19 Vaccine.” With the global COVID-19 pandemic, we recognize a significant need for SARS-CoV-2 vaccines that reduce infection in exposed individuals, reduce the amount of viral shedding in infected individuals and reduce transmission from infected individuals to close contacts. Addressing the COVID-19 pandemic, the National Institutes of Health (NIH) led rapid constitution of the CoVPN, partnering 5 NIH supported clinical trial networks, to create an enhanced network of physician-scientists at 145 United States (US) and 71 international clinical trial sites in 17 countries dedicated to developing globally effective vaccines for SARS-CoV-2. Due to its extensive experience implementing global HIV vaccine trials over the last 20 years, the HIV Vaccine Trials Network (HVTN) LOC was selected as the LOC for CoVPN vaccine trials. This study will monitor the efficacy of the Federal Drug Administration (FDA) Emergency Use Authorized (EUA) Moderna COVID-19 Vaccine to prevent infection in an immediate versus delayed vaccination college student cohort. Participants will be recruited from over 20 universities across the United States and will include three cohorts: 12,000 healthy volunteers aged 18 through 26 years to receive immediate (month 0) or delayed (month 4) vaccination (Main Cohort), up to 24,000 volunteers subject to university SARS-CoV-2 testing who are in close physical proximity with main cohort participants (Prospective Close Contact (PCC) Cohort), and approximately 3 contacts per incidence case for a total of up to 1,500 individuals who have been in close contact with a SARS- CoV-2 positive case from the Main Cohort (Case-Ascertained Close Contact (CACC) Cohort). Participants in the main study will be unblinded to randomization and will be administered vaccine at day 1 (D1) and D29 for the immediate vaccination arm, and at D113 and D141 for the delayed vaccination arm. They will self-collect nasal swabs daily in order to capture all incident SARS-CoVE-2 infection events over 4 months of follow-up and to capture the full course of viral shedding – from onset of infection to viral clearance – among those with both asymptomatic and symptomatic infection. To minimize participant burden and maximize study efficiency many study procedures will occur remotely. SARS-CoV-2 infected participants will complete daily e- diaries to capture symptoms. All trial endpoint assays will be done using qualified and validated assays for diagnosis and immune monitoring and the primary analyses will be conducted among baseline seronegative participants (targeting an entry seropositive rate of < 10%). Specific aims of this study are to assess the clinical efficacy of the Moderna COVID-19 Vaccine to prevent SARS- CoV-2 infection in naïve adults; to evaluate the vaccine effect on peak nasal viral load as a measure of infection and proxy of infectiousness; to evaluate the impact of the vaccine on secondary transmission of SARS-CoV-2 infection; to evaluate vaccine efficacy against COVID-19 disease; and to evaluate the immunogenicity of the vaccine. This trial will add a great deal to our understanding on how effective these vaccines are in reducing and modifying infection as well as preventing transmission to persons living near vaccinated individuals. It will also improve our understanding of the viral dynamics in SARS-CoV-2 mRNA vaccinated individuals. Lastly, the results of this trial will be used to modify future COVID-19 vaccine trials targeting both personal protection and prevention of transmission.

项目摘要 该提案概述了 COVID-19 预防网络 (CoVPN) 疫苗的科学议程 领导运营中心 (LOC) 负责实施题为“随机对照试验”的 COVID-19 疫苗试验 评估 SARS-CoV-2 感染、病毒脱落以及随后的潜在传播的对照研究 大学生接种了 Moderna COVID-19 疫苗。” 随着全球 COVID-19 大流行，我们认识到对 SARS-CoV-2 疫苗的巨大需求，以减少 暴露个体的感染，减少感染个体的病毒脱落量，并减少 国家应对新冠肺炎 (COVID-19) 疫情从感染者传播到密切接触者。 卫生研究院 (NIH) 领导了 CoVPN 的快速组建，与 5 个 NIH 支持的临床试验网络合作， 在 145 个美国和 71 个国际临床试验中建立一个增强的医师科学家网络 由于其广泛性，17 个国家的研究中心致力于开发全球有效的 SARS-CoV-2 疫苗。 过去 20 年实施全球 HIV 疫苗试验的经验，HIV 疫苗试验网络 (HVTN) LOC 被选为 CoVPN 疫苗试验的 LOC。 本研究将监测联邦药物管理局 (FDA) 紧急使用授权 (EUA) 的功效 Moderna COVID-19 疫苗可预防立即接种疫苗与延迟接种疫苗的大学生感染 参与者将从美国 20 多所大学招募，其中包括三所大学。 队列：12,000 名 18 至 26 岁的健康志愿者立即（第 0 个月）或延迟（第 0 个月）接受治疗 4) 疫苗接种（主要队列），最多 24,000 名密切接触的志愿者受试者接受大学 SARS-CoV-2 检测 与主要队列参与者（预期密切接触 (PCC) 队列）的物理距离，以及大约 每个病例有 3 名接触者，总计多达 1,500 名与 SARS 密切接触的人 来自主要队列（病例确定的密切接触者 (CACC) 队列）的 CoV-2 阳性病例。 主要研究的参与者将对随机分组不设盲，并将在第 1 天 (D1) 接种疫苗 立即疫苗接种组为 D29，延迟疫苗接种组为 D113 和 D141。 每天自行收集鼻拭子，以捕获 4 个月内的所有 SARS-CoVE-2 感染事件 跟踪并捕捉病毒脱落的整个过程——从感染开始到病毒清除—— 最大限度地减少参与者的负担并最大化研究。 许多研究程序将远程进行，感染 SARS-CoV-2 的参与者将每天以电子方式完成。 所有试验终点检测都将使用合格且经过验证的检测来完成。 诊断和免疫监测以及初步分析将在基线血清阴性人群中进行 参与者（目标是入组血清阳性率 < 10%）。 本研究的具体目的是评估 Moderna COVID-19 疫苗预防 SARS 的临床疗效 首次感染成人的 CoV-2 感染；评估疫苗对鼻腔病毒载量峰值的影响，作为感染的衡量标准 和传染性代理；评估疫苗对 SARS-CoV-2 二次传播的影响 感染；评估疫苗对 COVID-19 疾病的功效；并评估疫苗的免疫原性； 这项试验将大大加深我们对这些疫苗在减少病毒感染方面的有效性的了解。 改变感染并防止传播给住院患者附近的人。 还提高了我们对 SARS-CoV-2 mRNA 个体中病毒动态的了解。 该试验的结果将用于修改未来的 COVID-19 疫苗试验，目标是个人防护和 预防传播。