CoVPN 3003 - A Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older SDMC

CoVPN 3003 - 一项 3 期研究，旨在评估 Ad26.COV2.S 在 18 岁及以上成人中预防 SARS-CoV-2 介导的 COVID-19 的功效和安全性 SDMC

• 批准号: 10581379
• 负责人: Peter B. Gilbert
• 金额: $ 26.08万
• 依托单位: FRED HUTCHINSON CANCER CENTER
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-06-29 至 2027-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10581379
• 关键词: 18 year old; 2019-nCoV; Address; Adenoviruses; Adult; Age-Years; Antibody Response; Antigens; Binding; Biological Assay; Biometry; COVID-19; COVID-19 Prevention Network; COVID-19 outbreak; COVID-19 pandemic; COVID-19 prevention; COVID-19 screening; COVID-19 severity; COVID-19 vaccine; Cellular Assay; Clinical; Clinical Trials; Clinical Trials Network; Cohort Studies; Communicable Diseases; Constitution; Country; Data Analytics; Development; Diagnosis; Disease; Dose; Double-Blind Method; Emergency department visit; End Point Assay; Eye; Future; Goals; HIV Vaccine Trials Network; HIV vaccine; Health; Hospitalization; Immune; Immune response; Immunity; Immunologic Monitoring; Immunology; Individual; Infection; Infection Control; Infection prevention; International; Intervention; Intramuscular; Intramuscular Injections; Knowledge; Laboratories; Latin America; Lead; Leadership; Malaria; Mediating; Medical; Monitor; Morbidity - disease rate; Participant; Persons; Phase; Physicians; Placebo Control; Placebos; Population; Preparation; Prevention; Preventive; Protocols documentation; Quality Control; Randomized; Randomized Clinical Trials; Recombinants; Research Methodology; Risk; SARS-CoV-2 infection; SARS-CoV-2 spike protein; Safety; Sampling; Scientist; Serology test; Serum; Site; South Africa; System; Testing; Therapeutic Monoclonal Antibodies; Typhoid Fever; United States; United States National Institutes of Health; Vaccines; Validation; Viral; adaptive immune response; base; clinical trial analysis; design; efficacy study; efficacy testing; efficacy trial; experience; high risk; immune function; improved; mortality; neutralizing antibody; operation; particle; phase 3 study; prevent; programs; quality assurance; racial and ethnic; racial diversity; rational design; recruit; remote monitoring; response; severe COVID-19; symptomatic COVID-19; vaccine trial; vector; vector vaccine

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 efficacy trial entitled “A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older.” With the global COVID-19 pandemic, we recognize a significant need for vaccines that modify COVID-19 in SARS-CoV-2 infected individuals. Addressing this gap, 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 64 United States (US) and 55 international clinical trial sites in 15 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 phase 3, placebo-controlled, double-blinded study will test the efficacy of Ad26.COV2.S, a recombinant, replication-incompetent adenovirus type 26 (Ad26) vector constructed to encode the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) spike (S) protein to modify COVID-19 disease in adults 18 year of age and older. Participants will be recruited from clinical trial sites across the US, Latin America and South Africa using data analytics to target high risk individuals with a diverse racial and ethnic profile. Participants will receive symptomatic screening for SARS-CoV-2 infection, and if they become infected will be monitored with frequent clinical check-ins and remote monitoring of vital signs. Infected individuals who progress to moderate-severe COVID-19 will be referred for hospitalization. All trial endpoint assays will be done using qualified and validated assays for diagnosis and immune monitoring. Specific aims of this study are to demonstrate efficacy of Ad26.COV2.S to prevent COVID-19, to evaluate the safety, tolerability and reactogenicity of one intramuscular (IM) injection of 1x1011 viral particles (vp) or placebo, to assess the ability to prevent infection with SARS-CoV-2, to assess the ability to modify COVID-19 disease, to assess the ability to prevent emergency room visits, and to evaluate the binding and neutralizing antibody responses. This efficacy trial will tell us much about the adaptive immune response in persons who receive a SARS-CoV-2 S protein-based vaccine and about their ability to modify the disease course of COVID-19. In addition, it will improve our understanding of the dynamics and duration of these immune responses and will inform rational design and testing of preventive and therapeutic monoclonal antibody interventions. Lastly, the results of this trial will be used to assess registration of this vaccine product as well as to modify future COVID- 19 vaccine trials planned over the next 12 months.

项目摘要 该提案概述了 COVID-19 预防网络 (CoVPN) 疫苗领导层的科学议程 运营中心 (LOC) 负责实施题为“随机、随机、 双盲、安慰剂对照 3 期研究评估 Ad26.COV2.S 的功效和安全性 在 18 岁及以上成年人中预防 SARS-CoV-2 介导的 COVID-19。” 随着全球 COVID-19 大流行，我们认识到对改变 COVID-19 的疫苗的巨大需求 SARS-CoV-2 感染者。为了解决这一差距，美国国立卫生研究院 (NIH) 迅速领导了 CoVPN 的组成，与 5 个 NIH 支持的临床试验网络合作，创建一个增强的网络 64 个美国 (US) 和 15 个国家的 55 个国际临床试验中心的医师科学家致力于 开发全球有效的 SARS-CoV-2 疫苗。由于其丰富的全球实施经验 过去 20 年的 HIV 疫苗试验，HIV 疫苗试验网络 (HVTN) LOC 被选为 LOC 用于 CoVPN 疫苗试验。 这项 3 期安慰剂对照双盲研究将测试 Ad26.COV2.S 的功效，Ad26.COV2.S 是一种重组、 构建编码严重急性呼吸道病毒的复制无能腺病毒 26 型 (Ad26) 载体 综合征冠状病毒-2 (SARS-CoV-2) 刺突 (S) 蛋白可改变 18 岁成人的 COVID-19 疾病 和年纪大了。参与者将从美国、拉丁美洲和南美的临床试验地点招募 非洲利用数据分析来针对具有不同种族和民族特征的高风险人群。 参与者将接受 SARS-CoV-2 感染症状筛查，如果被感染，将接受 通过频繁的临床检查和生命体征的远程监测进行监测。进展的感染者 中度至重度的 COVID-19 将被转诊住院治疗。所有试验终点检测都将完成 使用合格且经过验证的检测方法进行诊断和免疫监测。 本研究的具体目的是证明 Ad26.COV2.S 预防 COVID-19 的功效，以评估 一次肌内 (IM) 注射 1x1011 病毒颗粒 (vp) 或安慰剂的安全性、耐受性和反应原性， 评估预防 SARS-CoV-2 感染的能力，评估改变 COVID-19 疾病的能力， 评估防止急诊室就诊的能力，并评估结合和中和抗体 回应。这项功效试验将告诉我们很多有关接受免疫治疗的人的适应性免疫反应的信息。 SARS-CoV-2 S 蛋白疫苗及其改变 COVID-19 病程的能力。在 此外，它将提高我们对这些免疫反应的动态和持续时间的理解，并将 为预防性和治疗性单克隆抗体干预措施的合理设计和测试提供信息。最后， 该试验的结果将用于评估该疫苗产品的注册以及修改未来的新冠病毒- 计划在未来 12 个月内进行 19 项疫苗试验。