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.

抽象的 2020年3月11日，世界卫生组织（WHO）宣布了全球冠状病毒 疾病2019（Covid-19）大流行。该疾病的特征是严重的流感症状， 与SARS-COV-2诱导的死亡的高龄（> 65岁）成为一个重要的危险因素。当前的 临床阶段COV-2疫苗计划必须包括这个重要和脆弱的人群 它们的初始测试，并产生对战斗的快速抗体和细胞特异性反应 疾病。整合素激活化合物是可以增强生产力的免疫调节剂 对疫苗抗原的反应；我们的初步数据使我们有着强烈的信心他们可能是 同样有效地提高冠状病毒（Covid-19）疫苗的有效性，尤其是在 老年人。这项研究将直接检验一个新颖的专有整合素的假设 用SARS-COV-2尖峰蛋白（包含RBD的域）传递的激活剂（7HP349） 候选疫苗将产生高滴度中和抗体，以产生保护性 结果（中和）在病毒剂后挑战。我们的前提是7HP349可以是 用作口服免疫激活剂，以增强疫苗的全身免疫力作为预防性工具 控制SARS-COV-2的传播。此外，它设想与现有的 疫苗无需抗原重新制定。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Covid-19疾病。