AIVITA Biomedical, Inc., a biotech company specializing in innovative cell applications, today announced the publication of safety and efficacy results from Phase 1 and Phase 2 clinical trials investigating its anti-SARS-CoV-2 vaccine candidate AV-COVID-19 that is made at point-of-care by third-party personnel. The results were published in the article “A Personal COVID-19 Dendritic Cell Vaccine Made at Point-of-Care: Feasibility, Safety, and Antigen-Specific Cellular Immune Responses” in the journal Human Vaccines & Immunotherapeutics. Across both studies, AV-COVID-19 was well-tolerated with very few and low-grade adverse events. Single injections induced desirable antigen-specific T-cell responses in 94% of participants at 14 days and 97% of participants at 28 days.
Also Read: Haemonetics Announces Agreement to Offer Enhanced Transfusion Management Software
“Our vaccine uniquely induces direct cell-mediated immune memory,” explained Gabriel Nistor, M.D., chief science officer at AIVITA. “This is an important distinction from currently available COVID-19 vaccines which all induce a transitory antibody-mediated immune response.”
The personal vaccine made at point-of-care generated enhanced T-cell responses in 96.8% of evaluable subjects.
“The superior safety profile is likely due to our vaccine containing only the subject’s primed immune cells and none of the viral antigen, virus, mRNA, DNA, animal components or immune adjuvants found in other vaccines,” said Robert O. Dillman, M.D., chief medical officer at AIVITA. “This may alleviate vaccine hesitancy, providing an option for those who are dubious of current vaccine modalities or have strict prohibitions regarding the use of animal components.”
The objectives of these studies were to provide safety and immune response data for single injections of different formulations of the AV-COVID-19 SARS-CoV-2 vaccine and to also establish the feasibility of preparing personal dendritic cell vaccines at point-of-care.
In the double-blind, randomized Phase 1 trial, 31 subjects ages 20-62 years received one of nine formulations of autologous dendritic cells and lymphocytes (DCL) incubated with 0.10, 0.33, or 1.0 μg of recombinant SARS-CoV-2 spike protein, and then admixed with saline or 250 or 500 μg of granulocyte-macrophage colony-stimulating factor (GM-CSF). Subjects were assessed for safety and humoral response. All formulations were well-tolerated with no acute allergic events, serious adverse events (SAE), or grade 3 or 4 adverse events (AE). Immune response was determined by an enzyme-linked immunosorbent assay (ELISA) used to measure antigen-specific immunoglobulin levels specific for the S-protein recombinant binding domain (RBD). Comparisons were made between results at day-0 and day-28. Investigators found that 21/30 (70%) subjects had an increase in anti-RBD antibody levels on day-28.