Integrin Activation to Augment SARS-CoV-2 Vaccination

整合素激活增强 SARS-CoV-2 疫苗接种

• 批准号: 10254720
• 负责人: JEFFREY K ACTOR
• 金额: $ 29.77万
• 依托单位: 7 HILLS PHARMA, LLC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-05-01 至 2022-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10254720
• 关键词: 2019-nCoV; Adjuvant; Adult; Animals; Antibodies; Antibody Formation; Antibody Response; Antibody titer measurement; Antigens; Antiviral Agents; COVID-19; COVID-19 mortality; COVID-19 pandemic; COVID-19 vaccination; COVID-19 vaccine; Clinical; Clinical Research; Clinical Trials; Coronavirus; Data; Disease; Dose; Effectiveness; Elderly; Evaluation; Fluzone; Generations; Goals; Health; Health Benefit; Histologic; Host Defense; Human; Immune; Immune response; Immunity; Immunization; Immunize; Immunomodulators; Individual; Integrins; Knowledge; Lead; Lung diseases; Medicine; Metabolic Diseases; Modeling; Morbidity - disease rate; Mus; New York; Oral; Outcome; Pathogenicity; Patients; Phase; Pneumonia; Population; Preparation; Public Health; Recombinant Proteins; Risk Factors; SARS-CoV-2 infection; SARS-CoV-2 spike protein; Schedule; Symptoms; T cell response; Testing; Vaccinated; Vaccination; Vaccine Antigen; Vaccines; Viral; Virus; Vulnerable Populations; World Health Organization; aged; aging population; base; college; combat; comorbidity; dosage; efficacy evaluation; experimental study; flu; human old age (65+); human subject; immunogenicity; infectious disease model; medical schools; meetings; mortality; neutralizing antibody; novel; phase 1 study; phase 2 study; programs; prophylactic; receptor binding; response; safety study; seroconversion; tool; transmission process; vaccine candidate; vaccine effectiveness

Abstract On March 11, 2020 the World Health Organization (WHO) announced a global Coronavirus Disease 2019 (COVID-19) pandemic. The disease is characterized by severe flu-like symptoms, with advanced age (>65 years) an important risk factor for SARS-CoV-2-induced death. Current clinical stage CoV-2 vaccine programs must include this important and vulnerable population in their initial testing, and generate rapid antibody and cellular specific responses to combat disease. Integrin activating compounds are immune modulators that can potentiate productive responses to vaccine antigens; our preliminary data gives us strong confidence they may be similarly effective in enhancing effectiveness of a coronavirus (COVID-19) vaccine, especially in aged populations. This study will directly test the hypothesis that a novel, proprietary integrin activator (7HP349) delivered with the SARS-CoV-2 spike protein (RBD containing domain) vaccine candidate will generate high titer neutralizing antibodies that will yield protective outcome (neutralization) post challenge with viral agents. Our premise is that 7HP349 can be used as oral immune activator to augment systemic immunity of vaccines as a prophylactic tool to control spread of SARS-CoV-2. It is furthermore envisioned to be used with an existing vaccine without requiring antigen reformulation. Our ultimate goal is to ameliorate coronavirus burden and subsequent COVID-19 disease in both adult and aged individuals.

摘要 2020年3月11日，世界卫生组织(WHO)宣布了一种全球冠状病毒 疾病2019年(新冠肺炎)大流行。这种疾病的特点是严重的流感样症状， 高龄(65岁)是SARS-CoV-2导致死亡的重要危险因素。当前 临床阶段CoV-2疫苗计划必须将这一重要和脆弱的人群包括在 它们的初步检测，并产生快速抗体和细胞特异性反应，以打击 疾病。整合素激活化合物是一种免疫调节剂，可以增强 对疫苗抗原的反应；我们的初步数据给了我们很强的信心 同样有效地增强了冠状病毒(新冠肺炎)疫苗的效力，特别是在 老龄化人口。这项研究将直接检验一种新的、专有的整合素的假设 SARS-CoV-2刺突蛋白(含RBD结构域)携带的激活物(7HP349) 候选疫苗将产生高滴度的中和抗体，从而产生保护性 用病毒制剂挑战后的结果(中和)。我们的前提是7HP349可以 作为口服免疫激活剂的疫苗作为预防工具增强系统免疫 控制SARS-CoV-2的传播。此外，它还设想与现有的 疫苗不需要重新配制抗原。我们的最终目标是改善冠状病毒 成人和老年人的负担和随后的新冠肺炎病。