SARS-CoV-2 Vaccine

AV-COVID-19 is a patient-specific dendritic cell vaccine that contains peripheral blood monocyte-derived dendritic cells, which are extracted from a blood sample from the recipient. These cells are loaded ex-vivo with SARS-CoV-2 spike protein associated with binding and infectivity. The antigen-loaded dendritic cells are administered to the recipient through a subcutaneous injection to the tissue just under the skin, with the purpose of creating adaptive immunity against the SARS-CoV-2 virus quickly without the common side effects of other vaccines associated with viral protein production in the blood (headache/fever/etc.) and administration via intramuscular injection (arm pain).

AIVITA is evaluating AV-COVID-19 in a 180-participant Phase 2 clinical study in Indonesia, following a successful a Phase 1 clinical study showing highly favorable safety and preliminary efficacy. In a preclinical study, AIVITA observed multiple SARS-CoV-2 antigens reacting with natural immunoglobulins from COVID-19 convalescent patient serum, demonstrating them to be suitable immune targets for SARS-CoV-2 vaccine production. It was also observed that there was no damage during vaccine production when these antigens were loaded onto the dendritic cells. Importantly, these antigen-loaded dendritic cells mounted an immune response in lymphocytes from the same patient, showing immune activation from the vaccine. Vaccinated mice were also shown to produce antibodies and a cellular immune response very quickly, in a third party GLP setting.

A key benefit of AIVITA’s approach is its potential for rapid scalability and mass distribution. Given the right tools, any one of thousands of minimally-equipped laboratory settings nationwide, or worldwide, could manufacture the patient-specific vaccine using AIVITA’s proprietary reagents.