Bavarian Nordic A/S reported initial results from the first-in-human trial of ABNCoV2, led by the PREVENT-nCoV consortium.

The Phase 1/2 dose-escalation trial enrolled 45 healthy SARS-CoV-2-na?ve adult volunteers at the Radboud University Medical Centre in the Netherlands, who received two doses (dose ranges from 6-70 μg) of ABNCoV2, formulated with and without adjuvant. The results demonstrate that the vaccine was well tolerated across all dose groups with no observed difference in the adverse event profile after first and second vaccination. No serious adverse events were reported and the safety profile was comparable to other vaccines based on recombinant protein-technology.

In all dose groups, antibody titers were significantly higher after the boost vaccination and were up to 12-fold higher than those measured in convalescent human samples and significantly higher than those reported for current approved COVID-19 vaccines. Importantly, high neutralization titers were demonstrated against all SARS-CoV-2 variants of concern, including the dominant Delta variant.

Final results from the study are expected later in the second half of 2021.

Paul Chaplin, President and CEO of Bavarian Nordic, commented: “We are very pleased to report positive results from this first-in-human trial of our COVID-19 vaccine, confirming its ability to induce strong and broad antibody levels, superior to those of the current approved vaccines, while also providing a favorable safety profile. These data are highly encouraging for our planned Phase 2 trial later this month, which is designed to evaluate the vaccine’s potential as a universal booster vaccine.”

Bavarian Nordic will further advance the development of the vaccine candidate and has planned a Phase 2 trial in up to 210 subjects. The aim of the trial, in addition to confirming the Phase 1 findings, is to evaluate ABNCoV2 as a booster vaccine for individuals with previous COVID-19 disease or vaccination. The trial will be conducted at two centers in Germany and is expected to be initiated later in August, pending final approval from the Ethics Committee. In parallel, Bavarian Nordic is preparing for a Phase 3 trial of ABNCoV2 in 2022, pending external funding.