AIVITA Biomedical has reported data from Phase II clinical trial of its anti-SARS-CoV-2 Vaccine Enabling Kit, which enables the creation of personalised Covid-19 vaccines.
Any minimally-equipped facility can use AIVITA’s kit to make individualised vaccines during the period of two patient visits at a gap of one week.
Data from the Phase II trial revealed that the personalised vaccine produces a higher immune memory response to the SARS-CoV-2 virus in 96% of inoculated participants. This was observed in a setting where the delta variant was dominant.
The vaccine was also observed to be associated with less and low-grade adverse events, without any serious adverse events.
With 145 participants aged 19.5 to 82.8 years, the randomised and double-blind Phase II trial assessed three different S-protein quantities incubated with each participant’s dendritic cell-lymphocyte product to create the vaccine.
Blood samples were evaluated for immune memory response at the time of inoculation, and two and four weeks later.
The vaccine’s cellular nature enables it to deliver a direct cell-mediated immune memory after vaccination, AIVITA noted.
In 96% of inoculated participants, an immune memory response against the Covid-19 virus was found to be enhanced.
No difference was reported among the three vaccine formulations tested. All three were well-tolerated without high-grade or serious adverse events.
AIVITA Biomedical chief medical officer Robert Dillman said: “Having only 53% of subjects experience adverse events is much lower than that reported for other Covid-19 vaccines that are currently available, for which 90% to 100% of subjects reported adverse events.
“The vast majority of adverse events reported by subjects were characterised as mild, that is, grade 1 in severity, befitting a personalised vaccine.”
The Phase II trial was carried out in Indonesia and follows a Phase Ib trial, where all nine formulations of the personalised vaccine were well-tolerated.
AIVITA Biomedical also develops treatments for various cancers, including melanoma and glioblastoma.