HVTN 405/HPTN 1901 Characterizing SARS-CoV-2-specific immunity in convalescent individuals: LC

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

• 批准号: 10165321
• 负责人: Margaret Juliana McElrath
• 金额: $ 2995.23万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH CENTER
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-06-24 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10165321
• 关键词: 2019-nCoV; AIDS prevention; ALVAC; Acute; Adult; Age-Years; Biological Assay; Biometry; COVID-19; COVID-19 pandemic; COVID-19 vaccine; Cells; Cellular Assay; Chronic; Clinical; Clinical Trials; Cohort Studies; Collaborations; Communicable Diseases; Country; Development; Disease; Disease Outbreaks; Epitopes; Eye; Future; Goals; HIV Vaccine Trials Network; HIV vaccine; HIV/TB; Health; Immune; Immune response; Immune system; Immunity; Immunologic Markers; Immunologics; Immunology; Immunology procedure; Immunotherapeutic agent; Individual; Infection; Infection Control; Infection prevention; Inflammation; Intubation; Joints; Knowledge; Laboratories; Lead; Leadership; Light; Malaria; Measures; Mediating; Medical; Medical History; Monoclonal Antibodies; Monoclonal Antibody Therapy; Morbidity - disease rate; Myocarditis; National Institute of Allergy and Infectious Disease; Participant; Pathologic; Pericarditis; Persons; Peru; Pharmaceutical Preparations; Phase; Physicians; Play; Population; Preparation; Prevention; Preventive vaccine; Prospective Studies; Protocols documentation; Quality Control; Randomized; Randomized Clinical Trials; Reagent; Research Methodology; Risk; Role; Sampling; Science; Scientist; Series; Serological; Severity of illness; Site; Specificity; System; Testing; Typhoid Fever; United States; Vaccination; Vaccines; Validation; Virus; Virus Diseases; Virus Shedding; adaptive immune response; clinical development; clinical trial analysis; cohort; coronavirus disease; design; efficacy study; efficacy trial; experience; illness length; immune function; improved; interest; mortality; neutralizing monoclonal antibodies; neutralizing vaccine; operation; pandemic disease; prevent; programs; quality assurance; recruit; response; therapeutic vaccine; vaccine trial; vector-based vaccine; virology

This proposal outlines the scientific agenda for the Leadership and Operations Center of the HIV Vaccine Trials Network (HVTN), the collaboration of physician scientists at 64 clinical trial sites in 15 countries on 4 continents dedicated to developing globally effective vaccines for HIV, tuberculosis and now SARS-CoV-2. The HVTN has led HIV prevention science for over 20 years through robust phase 1 and 2 clinical development trials and currently has 2 vector based vaccines (ALVAC and Ad26) and 1 broadly neutralizing monoclonal antibody (mAb) VRC01 undergoing testing in 5 randomized controlled efficacy trials. With the rapid onset of the COVID-19 pandemic, we recognize there is a significant gap in knowledge in the field on the contribution of immune functions involved in preventing infection, in modifying COVID-19 disease, and in clearing viral infection. We believe the HVTN is well placed to study these gaps and rapidly deploy this information in the development of SARS-CoV-2 neutralizing vaccines and mAb therapies. In this study we propose initiating an observational cohort study of approximately 400 persons in the United States (22 trials sites) and Peru (5 sites) convalescing from SARS-CoV-2 infection. Participants will be recruited from a variety of risk groups and clinical cohorts: hospitalized vs. non-hospitalized, symptomatic vs. asymptomatic, adults between 18 and 55 years of age and those older than 55 years, and persons with high interest clinical or virologic presentations (eg, persons who developed myocarditis/pericarditis, required intubation, had prolonged viral shedding, or who develop a positive virologic test after initially clearing the infection). Specific aims of this study include identifying serologic reactivities that differentiate SARS-CoV-2 infection from vaccination, to develop and qualify a suite of immunologic assays and reference reagents that will permit detailed interrogations of the immune response to infection, to measure SARS-CoV-2 adaptive response in key populations and risk groups, and to characterize presentations of the infection among convalescent individuals. This initial study will tell us much about the adaptive immune responses in persons who have been infected and recovered from SARS-CoV-2 and will shed light on the role the immune system plays in successfully clearance of infection. It will improve our understanding of the dynamics and duration of responses, as well as the epitope specificity and other defining signatures, and will inform rational design and testing of preventive and therapeutic vaccines and monoclonal antibodies. In addition, this protocol will lay the groundwork for prospective studies of this infection, better defining key risk groups and knowledge gaps. Lastly, this study will prepare the network for the large number of COVID-19 vaccines now entering the clinical trial pipeline. Laboratory, statistical and operational experience in this first trial will be invaluable preparation and priming of network machinery as the HVTN prepare to roll-out several efficacy trials as part of the joint NIAID COVID Prevention Network in coming months.

本提案概述了艾滋病毒疫苗领导和行动中心的科学议程