AIVITA Publishes Phase 1 and 2 Trial Results of Novel COVID-19 Vaccine

Today, the company AIVITA Biomedical, Inc., announced the publication of phase 1 and 2 results from clinical trials for their COVID-19 vaccine candidate. The anti-SARS-CoV-2 vaccine, AV-COVID-19, was well-tolerated with very infrequent and mild adverse events.

The vaccine data was published online today in the journal Human Vaccines & Immunotherapeutics. The purpose of the study was to explore the potential of personal dendritic cell vaccines to the SARS-CoV-2 protein, establish the safety of a single subcutaneous injection, and analyze the antigen-specific immune response following vaccination.

In the double-blind, randomized, phase 1 study, 31 participants were assigned to 1 of 9 formulations of autologous dendritic cells and lymphocytes (DCL). The formulations were incubated with 0.10, 0.33, of 1.0 µg of recombinant SARS-CoV-2 spike protein, admixed with either saline, 250, or 500 µg of granulocyte-macrophage colony-stimulating factor (GM-CSF) before injection. The study patients were monitored for safety and humoral response.

In phase 2, 145 participants were randomized to 1 of 3 formulations, defined by incubation with the same 3 quantities of spike protein without GM-CSF. Approximately 46.4% of subjects had a grade 1 adverse event, and 6.5% had a grade 2 AE. Among all 169 participants, there were no acute allergic, grade 3 or 4, or serious AEs.

“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, MD, chief medical officer at AIVITA.

In phase 1 of the AV-COVID-19 study, anti-receptor binding domain antibodies increased in 70% of study patients by day 28. In phase 2, among the 127 participants who did not have high levels of gamma interferon-producing cells at baseline, 94.4% had increased by day 14 and 96.8% increased by day 28.

“Our vaccine uniquely induces direct cell-mediated immune memory,” said Gabriel Nistor, MD, 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.”

AIVITA Biomedical, Inc. was founded in 2016, specializing in cancer immunotherapy and personalized vaccines. According to AIVITA CEO, Hans S. Keirstead, PhD, “Our Vaccine-Enabling Kit can be shipped anywhere in the world, enabling distributed scaled manufacturing, and can be modified within days to accommodate new variants or entirely new pathogens."