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：现有NIH赠款和合作协议的行政补品 活动代码/奖励：UM1/A1068614-15（父母奖） -------------------------------------------------------------------------------------------------------------------------------- 项目摘要 该提案概述了COVID-19预防网络（COVPN）疫苗的科学议程 领导力运营中心（LOC）实施COVID-19疫苗效率试验，标题为“ 平行组，第三阶段，多阶段，改良的双盲，多军武装研究，以评估效率，安全性， 两种SARS-COV-2调整后的重组蛋白疫苗的免疫原性（单价和二价） 预防18岁及以上的成年人的Covid-19。” 随着全球COVID-19的大流行，我们认识到对修改Covid-19的疫苗的重要需求 SARS-COV-2感染的个体。解决这一差距，美国国立卫生研究院（NIH）领导了快速 COVPN的配置，与5个NIH支持的临床试验网络合作，以创建一个增强的网络 美国145个（美国）和71个国际临床试验地点的物理科学家在17个国家 /地区致力于 为SARS-COV-2开发全球有效的疫苗。由于其广泛实施全球的经验 HIV疫苗试验在过去20年中，选择了HIV疫苗试验网络（HVTN）LOC作为LOC 用于COVPN疫苗试验。 该第3阶段，多阶段，修改的双盲，安慰剂对照，多军武装研究将测试效率， sanofi-pasteur sars-cov2预融合峰值三角洲TM的安全性和免疫原性，可调节， 单价D614（单价疫苗）和SARS-COV2插入峰值峰值Delta tm，可调节，二价 D614/B.1.351（双价疫苗），以修改18岁及以上的成年人的Covid-19疾病。参与者 将使用数据分析从美国的临床试验站点和全球范围内招募，以针对高风险 具有多样性种族和种族形象的个人。 参与者将接受SARS-COV-2感染的症状筛查，如果感染， 通过经常进行临床检查和对生命体征的远程监测进行监测。受感染的人 将转置为中期的Covid-19将被转交给住院。所有试验端点测定将使用 诊断和免疫监测的合格和验证测定法。 这项研究的具体目的是评估投资COV2 PRES DTM重组的临床效率 用AS03调整的蛋白质 - 幼稚的成年人的单价和双价（“研究疫苗”）进行预防 第二次注射后14天发生的有症状的covid-19；评估研究的安全 在整个研究中，疫苗与安慰剂相比；评估SARS-COV-2幼稚的参与者， COV2 PRES DTM-AS03疫苗的临床效率预防以下发生> 14天后 第二次注射：预防SARS-COV-2感染，预防严重的Covid-19；描述 SARS-COV-2中有症状的covid-19的疾病频率和疾病频谱 每个研究组。 这项效率试验将向我们介绍两种重组疫苗的能力，针对两种最大的疫苗 常见的SARS-COV-2变体，以诱导强大的适应性保护反应。诺瓦瓦克斯疫苗之后 是要测试效率的第二大大规模重组蛋白疫苗，这是第一个使用的试验 包括B.1.351的二价疫苗。如果成功，这将是一种重要的疫苗 迅速缩放并在世界范围内部署。该试验的结果将用于评估注册 该疫苗产品中的产品，还将提供关键信息，以告知Covid-19的子孙后代 疫苗。