CoVPN 3001 - A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults.

CoVPN 3001 - 一项 3 期、随机、分层、观察者盲法、安慰剂对照研究，旨在评估 mRNA-1273 SARS-CoV-2 疫苗在成人中的功效、安全性和免疫原性。

• 批准号: 10581323
• 负责人: Peter B. Gilbert
• 金额: $ 43.94万
• 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/10581323
• 关键词: 18 year old; 2019-nCoV; Address; Adult; Age-Years; 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; Cardiomyopathies; Cause of Death; Cellular Assay; Clinic; Clinical; Clinical Trials; Clinical Trials Network; Cohort Studies; Communicable Diseases; Communities; Data Analytics; Development; Diagnosis; Disease; Dose; Double-Blind Method; End Point Assay; Enrollment; Exposure to; Eye; Goals; HIV Vaccine Trials Network; HIV vaccine; Health; Home; Hospitalization; Immune; Immune response; Immunity; Immunologic Monitoring; Immunology; Individual; Infection; Infection Control; Infection prevention; Injections; Kinetics; Knowledge; Laboratories; Lead; Leadership; Lipids; Malaria; Meat; Mediating; Monitor; Morbidity - disease rate; Participant; Persons; Phase; Placebo Control; Plants; Population; Preparation; Prevention; Protocols documentation; Quality Control; RNA; Randomized; Randomized Clinical Trials; Research Methodology; Risk; SARS-CoV-2 infection; SARS-CoV-2 spike protein; Safety; Sampling; Series; Serology test; Site; System; Typhoid Fever; United States National Institutes of Health; Vaccines; Validation; Virus; Virus Diseases; adaptive immune response; base; blind; clinical trial analysis; design; efficacy evaluation; efficacy study; efficacy testing; efficacy trial; experience; high risk; immune function; immunogenicity; improved; mortality; operation; placebo controlled study; prevent; programs; quality assurance; racial and ethnic; racial diversity; recruit; remote monitoring; response; severe COVID-19; side effect; vaccine evaluation; vaccine trial

Project Abstract This proposal outlines the scientific agenda for the COVID-19 Prevention Network (CoVPN) Vaccines Leadership Operations Center (LOC) for continuing implementation of the first COVID-19 vaccine efficacy trial “A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 (Moderna) Vaccine 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 HVTN has joined 4 other National Institute of Health (NIH) clinical trial networks to form the CoVPN, an enhanced network dedicated to developing globally effective vaccines for SARS-CoV-2. Due to its extensive experience implementing HIV vaccine trials, the HIV Vaccine Trials Network (HVTN) LOC was selected to as the CoVPN vaccine LOC. This trial, a phase 3, placebo-controlled, double-blinded study will test the efficacy of mRNA-1273 SARS- CoV-2, a lipid co-formulated messenger ribonucleic acid (mRNA) vaccine encoding the SARS-CoV-2 spike protein (S), to modify COVID-19 disease in adults 18 year of age and older. Participants will be recruited from clinical trial sites across the US, using data analytics to target high risk individuals with a diverse racial and ethnic profile. In addition, the CoVPN will use accessory community-based sites, staffed by clinical teams from the home sites and employ mobile clinics to enroll individuals in new high risk settings (e.g., meat packing plants). 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 at CoVPN laboratories, using validated assays for diagnosis and immune monitoring. Specific aims of this study are to demonstrate efficacy of mRNA-1273 SARS-CoV-2 to prevent COVID-19, to evaluate the safety and reactogenicity of 2 injections given 28 days apart, the assess the ability to prevent infection with SARS-CoV-2, the assess the ability to modify COVID-19 infection, to evaluate viral infection kinetics, and to evaluate the vaccine induced immune response. A booster injection (3rd dose) will be offered to participants at least 6 months after the last dose of the primary series. This efficacy trial will tell us much about the adaptive immune response in persons who receive three doses of an mRNA SARS-CoV-2 S protein-based vaccine and about their ability to modify the disease course of COVID-19 against current circulating strains. In addition, It will improve our understanding of the dynamics and duration of these responses. Lastly, the results of this trial will enable assessment for rare side effects, such as cardiomyopathy, that wouldn’t otherwise be detected in smaller clinical trials. 1

项目摘要