HVTN 405/HPTN 1901 (CoVPN) Characterizing SARS-CoV-2-specific Immunity in Convalescent Individuals: LC 3

HVTN 405/HPTN 1901 (CoVPN) 表征恢复期个体的 SARS-CoV-2 特异性免疫：LC 3

• 批准号: 10570806
• 负责人: Margaret Juliana McElrath
• 金额: $ 132.48万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH CENTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-03-18 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10570806
• 关键词: 18 year old; 2019-nCoV; Address; Adjuvant; Administrative Supplement; Adult; Antigens; Award; Biological Assay; Biometry; COVID-19; COVID-19 Prevention Network; COVID-19 outbreak; COVID-19 pandemic; COVID-19 screening; COVID-19 severity; COVID-19 vaccine; Cellular Assay; Clinical; Clinical Trials; Clinical Trials Network; Code; Cohort Studies; Communicable Diseases; Constitution; Coronavirus; Country; Data Analytics; Development; Diagnosis; Disease; Double-Blind Method; End Point Assay; Eye; Frequencies; Future Generations; Goals; Grant; HIV Vaccine Trials Network; HIV vaccine; Health; Hospitalization; Immune; Immune response; Immunity; Immunologic Monitoring; Immunology; Individual; Infection Control; Infection prevention; Injections; International; Investigation; Knowledge; Laboratories; Lead; Leadership; Malaria; Mediating; Monitor; Morbidity - disease rate; Parents; Participant; Persons; Phase; Physicians; Placebo Control; Placebos; Population; Preparation; Prevention; Protocols documentation; Quality Control; Randomized Clinical Trials; Recombinant Proteins; Recombinant Vaccines; Research Methodology; Risk; SARS-CoV-2 B.1.351; SARS-CoV-2 infection; SARS-CoV-2 variant; Safety; Sampling; Scientist; Serology test; Site; System; Testing; Typhoid Fever; U-Series Cooperative Agreements; United States; United States National Institutes of Health; Vaccines; Validation; clinical efficacy; clinical trial analysis; design; efficacy study; efficacy testing; efficacy trial; experience; high risk; immune function; immunogenicity; improved; mortality; operation; prevent; programs; quality assurance; racial and ethnic; racial diversity; recruit; remote monitoring; response; safety study; scale up; severe COVID-19; symptomatic COVID-19; vaccine trial; variants of concern

FOA: PA-20-272: Administrative Supplements to Existing NIH Grants and Cooperative Agreements Activity Code/Award: UM1/A1068614-15 (parent award) ------------------------------------------------------------------------------------ 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 parallel-group, Phase III, multi-stage, modified double-blind, multi-armed study to assess the efficacy, safety, and immunogenicity of two SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines (monovalent and bivalent) for prevention against COVID-19 in adults 18 years of age 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 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 Phase 3, multi-stage, modified double-blind, placebo-controlled, multi-armed study will test the efficacy, safety and immunogenicity of Sanofi-Pasteur SARS-CoV2 prefusion Spike delta TM with AS03 adjuvant, monovalent D614 (monovalent vaccine) & SARS-CoV2 prefusion Spike delta TM with AS03 adjuvant, bivalent D614/B.1.351 (bivalent vaccine), to modify COVID-19 disease in adults 18 years of age and older. Participants will be recruited from clinical trial sites across the US and globally 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 assess the clinical efficacy of the investigational CoV2 preS dTM recombinant protein adjuvanted with AS03 – both monovalent and bivalent (“study vaccines”) in naïve adults for the prevention of symptomatic COVID-19 occurring > 14 days after the second injection; to assess the safety of the study vaccines compared to placebo throughout the study; to assess, in participants who are SARS-CoV-2 naïve, the clinical efficacy of the CoV2 preS dTM-AS03 vaccines for prevention of the following occurring > 14 days after the second injection: prevention of SARS-CoV-2 infection, prevention of severe COVID-19; to describe the frequency & spectrum of disease in episodes of symptomatic COVID-19 in SARS-CoV-2 non-naïve adults in each study group. This efficacy trial will tell us much about the ability of two recombinant vaccines, targeting two of the most common SARS-CoV-2 variants, to induce strong adaptive protective responses. After the Novavax vaccine, this is the second large scale recombinant protein vaccine to be tested for efficacy and it is the first trial to use a bivalent vaccine including the B.1.351 variant of concern. If successful, this will be an important vaccine that can be scaled up rapidly and deployed throughout the world. The results of this trial will be used to assess registration of this vaccine product and will also provide crucial information to inform future generations of COVID-19 vaccines.

FOA：PA-20-272：对现有 NIH 拨款和合作协议的行政补充 活动代码/奖项：UM1/A1068614-15（家长奖） -------------------------------------------------- ---------------------------------- 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“A 平行组、III 期、多阶段、改良双盲、多组研究，以评估疗效、安全性、 两种 SARS-CoV-2 佐剂重组蛋白疫苗（单价和二价）的免疫原性 用于预防 18 岁及以上成年人感染 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 美国国立卫生研究院 (NIH) 领导迅速解决了 SARS-CoV-2 感染者的问题。 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 145 个美国 (US) 和 17 个国家的 71 个国际临床试验中心的医师科学家致力于 凭借其在全球范围内实施的丰富经验，开发了全球有效的 SARS-CoV-2 疫苗。 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、多阶段、改良双盲、安慰剂对照、多组研究将测试疗效， 赛诺菲巴斯德 SARS-CoV2 预灌注 Spike delta TM 与 AS03 佐剂的安全性和免疫原性， 单价 D614（单价疫苗）和 SARS-CoV2 预融合 Spike delta TM 与 AS03 佐剂，二价 D614/B.1.351（二价疫苗），用于改变 18 岁及以上成人参与者的 COVID-19 疾病。 将从美国各地的临床试验地点招募全球人员，并使用数据分析来瞄准高风险 具有不同种族和民族特征的个人。 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对病情进展的感染者的远程监测进行监测。 中度至重度 COVID-19 将转诊住院治疗。 所有试验终点检测均将使用该方法进行。 用于诊断和免疫监测的合格且经过验证的检测。 本研究的具体目的是评估研究中的 CoV2 preS dTM 重组体的临床疗效 含有 AS03 佐剂的蛋白质 - 单价和二价（“研究疫苗”），用于幼稚成人的预防 第二次注射后 > 14 天出现有症状的 COVID-19；以评估研究的安全性； 在整个研究过程中将疫苗与安慰剂进行比较；以评估未接触过 SARS-CoV-2 的参与者的效果 CoV2 preS dTM-AS03 疫苗预防接种后 14 天以上发生以下情况的临床疗效 第二针：预防SARS-CoV-2感染，预防重症COVID-19； SARS-CoV-2 非首次感染成年人中出现症状的 COVID-19 的疾病频率和谱系 每个学习小组。 这项功效试验将告诉我们更多关于两种重组疫苗的能力，针对两种最常见的疫苗 常见的 SARS-CoV-2 变异体，在 Novavax 疫苗之后诱导强烈的适应性保护反应。 是第二个进行功效测试的大规模重组蛋白疫苗，也是首次使用 包括令人关注的 B.1.351 变体的二价疫苗如果成功，这将是一种重要的疫苗。 该试验的结果将用于评估注册。 该疫苗产品的详细信息，还将提供重要信息，以告知子孙后代有关 COVID-19 的信息 疫苗。