Kaiser Washington Vaccine and Treatment Evaluation Unit - DMID 21-0012

凯撒华盛顿疫苗和治疗评估单位 - DMID 21-0012

• 批准号: 10414676
• 负责人: LISA A JACKSON
• 金额: $ 201.46万
• 依托单位: KAISER FOUNDATION RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-12 至 2025-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10414676
• 关键词: Adenovirus Vector; Anthrax disease; Antigens; Award; COVID-19 pandemic; COVID-19 vaccine; Clinical Research; Clinical Trials; Communicable Diseases; Conduct Clinical Trials; Data; Diagnostic; Dose; Emerging Communicable Diseases; Enrollment; Evaluation; FDA Emergency Use Authorization; Foundations; Funding; Future; Grant; HIV; Immune response; Influenza; Knowledge; Malaria; Messenger RNA; Moderna COVID-19 vaccine; NIH Vaccine Research Center; National Institute of Allergy and Infectious Disease; Persons; Phase; Pneumococcal Infections; Proteins; Protocols documentation; Public Health; RNA vaccine; Request for Applications; Safety; Series; Site; Smallpox; Therapeutic; U-Series Cooperative Agreements; United States National Institutes of Health; Universities; Vaccines; Variant; Washington; base; clinical research site; immunogenicity; medical schools; novel vaccines; research study; therapeutic candidate; vaccine candidate; vaccine trial; vector vaccine

This Supplemental Funding application requests funding for the Kaiser Washington Vaccine and Treatment Evaluation Unit (VTEU) to function as a clinical site for DMID study 21-0012, a Phase 1/2 study of delayed heterologous SARS-CoV-2 vaccine dosing (boost) after receipt of EUA vaccines. This clinical trial will evaluate the safety and immunogenicity of different heterologous delayed doses (boosts) in those who received an EUA vaccine (either prior to participation in this trial, or as part of this trial). Since the 1960s the VTEUs have conducted trials of vaccines and therapeutic candidates for infectious diseases of public health importance (other than HIV) including, for example, influenza, malaria, smallpox, anthrax, and pneumococcal infection. Kaiser Washington has been continuously funded as a VTEU site since 2007, and in 2019 was awarded a seven-year cooperative agreement as one of ten VTEU sites in the newly formed NIAID Infectious Diseases Clinical Research Consortium (IDCRC). In 2020, the NIH and the IDCRC responded to the COVID-19 pandemic by launching the first trial (20-0003) of a candidate COVID-19 vaccine (mRNA-1273), an mRNA vaccine co-developed by the NIH Vaccine Research Center and Moderna, Inc, in March 2020. The Kaiser Washington VTEU was originally the sole site for that trial which was later expanded in terms of enrollment and sites, to also include the Emory University School of Medicine VTEU and the NIH Vaccine Research Center sites. mRNA-1273 has been granted Emergency Use Authorization, as has an mRNA vaccine from Pfizer and an adenovirus-vectored vaccine from Janssen. Knowledge of the safety, tolerability, and immunogenicity of a boost vaccine using a heterologous platform with the homologous or variant spike lineage administered after an EUA primary dosing is a critical piece of information needed to inform public health decisions. The heterologous boost strategy will also provide an opportunity to thoroughly evaluate innate, cellular, and humoral immune responses elicited from the multiple prime boost combinations using very similar immunogens, utilizing mRNA, adenovirus- vectored, and protein- based platforms. As new vaccines are manufactured to emerging variants, these foundational data will be key to the evaluation of future variant and heterologous prime-boost strategies.

本补充资金申请要求为凯撒华盛顿疫苗和治疗提供资金