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. Public Health Relevance Statement Narrative 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. Our proposal investigates the effectiveness of 7HP349 in conjunction with a COVID-19 vaccine candidate. The ultimate goal is to ameliorate coronavirus burden and subsequent COVID-19 disease in both adult and aged individuals.
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