The Phase 1/2 dose-escalation trial enrolled 45 healthy SARS-CoV-2-naïve adult volunteers at the Radboud University Medical Centre in the Netherlands, who received two doses 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.
ABNCoV2 is a next-generation COVID-19 vaccine candidate, initially developed by AdaptVac using their proprietary capsid virus like particle (cVLP) technology. AdaptVac is member of the PREVENT-nCoV consortium which has received a Horizon 2020 EU grant to fund the first-in-human trial of the vaccine. Other members of the consortium are ExpreS2ion, Leiden University Medical Center (LUMC), Institute for Tropical Medicine (ITM) at University of Tübingen, The Department of Immunology and Microbiology (ISIM) at University of Copenhagen, and the Laboratory of Virology at Wageningen University.
Bavarian Nordic has licensed the global commercialization rights to the vaccine and has assumed the responsibility for further clinical development towards licensure.