Multi-Pathogen Vaccine Kit

Sars-CoV-2_web
AIVITA Biomedical is using its patient-specific vaccine platform to develop a rapidly scalable multi-pathogen kit for the prevention of infectious diseases. AIVITA’s personalized vaccine begins with a basic blood draw, from which the recipient’s own immune cells are extracted and loaded with one or multiple antigen targets. The resulting vaccine is designed to create adaptive immunity against a range of infectious diseases.

AIVITA’s patient-specific vaccine platform has also been used to create treatments for multiple areas of cancer, with promising safety and efficacy reported to date.

AIVITA’s Multi-Pathogen Vaccine Kit enables 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 one or multiple target antigen. The antigen-loaded dendritic cells are administered to the recipient through a subcutaneous injection, with the purpose of creating adaptive immunity 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).

Clinical Studies

AIVITA investigated this vaccine approach in COVID-19 in a 180-participant Phase 2 clinical study in Indonesia, which followed a Phase 1 clinical study showing highly favorable safety and preliminary efficacy. Published results from those studies demonstrated a 96% T-cell response and far superior and longer-lasting protection compared to mRNA vaccines.[1] Notably, our vaccine provides superior protection well beyond 12 months, with the fewest and lowest adverse events of any available vaccine.[2] Importantly, these antigen-loaded dendritic cells mounted an immune response in lymphocytes from the same patient, showing immune activation from the vaccine.

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.

Dendritic cell-based treatments have been widely studied in the clinical setting, showing strong safety and antigen-specific efficacy for creating an adaptive immune response.

Each vaccine is personalized to the individual receiving it, using equipment and methods widely available in clinics worldwide.

  1. The process begins with a blood draw
  2. The blood is enriched for monocytes, a type of white blood cell that plays a role in innate immune response
  3. The monocytes are differentiated into dendritic cells, an immune messenger cell
  4. One or multiple target antigens are loaded onto the dendritic cells
  5. Following incubation, the vaccine is ready for administration