Safety and efficacy results from phase 1 and 2 clinical trials looking at a Covid-19 vaccine made at point-of-care by third party personnel have been published.
AIVITA Biomedical Inc., a biotech specializing in cell applications, made the announcement today (August 29). The results were published in the article in the journal Human Vaccines & Immunotherapeutics.
Well-tolerated
Across both studies, its candidate AV-COVID-19 was well-tolerated with very few and low-grade adverse effects.
Single injections induced the desirable antigen-specific T-cell response in 94% of participants in 14 days and 97% at 28 days.
“Our vaccine uniquely induces direct cell-mediated immune memory,” explained Gabriel Nistor, chief science officer at AIVITA Biomedical.
“This is an important distinction from currently available COVID-19 vaccines which all induce a transitory antibody-mediated immune response.”
Dendritic cell vaccines
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.
Robert Dillman, chief medical officer at AIVITA Biomedical, said: “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.
“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.”
Manufacturing of vaccines
The company says the successful manufacturing of vaccines for 176/176 subjects across two study sites supports the feasibility of point-of-care vaccine production in minimally equipped facilities by minimally trained third-party technicians using AIVITA’s vaccine-enabling kit.
“As COVID-19 rates continue to spike globally with new variants, many regions are still without access to COVID-19 vaccines due to their lack of ultra-cold chain distribution required by mRNA vaccines, the lack of supply, or the high cost,” said Hans Keirstead, chief executive officer at AIVITA.
“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.”
Personal vaccines
AIVITA Biomedical says the kit enables a subject-specific personal vaccine that consists of autologous dendritic cells and lymphocytes incubated with a quantity of SARS-CoV-2 spike protein. Creation of the vaccine requires basic laboratory techniques and AIVITA’s ready-made kit of materials.
Treatment starts with a blood draw from which the subject’s own immune cells are isolated and monocytes matured into antigen-presenting dendritic cells. The patient’s dendritic cells and lymphocytes are incubated with spike protein and delivered as a single dose of preventative vaccine via a single subcutaneous injection.