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.
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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.
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By GlobalDataThe 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.
