Bavarian Nordic has announced positive preliminary data from the first-in-human Phase I/II dose-escalation clinical trial of its Covid-19 vaccine, ABNCoV2.
Led by the PREVENT-nCoV consortium, the trial involved 45 healthy adults with no previous SARS-CoV-2 infection. Subjects were enrolled at Radboud University Medical Centre in the Netherlands.
Participants received two doses of the Covid-19 vaccine, at doses ranging from 6μg to 70μg, with and without adjuvant.
Data showed that ABNCoV2 was well tolerated across all doses tested without any difference in the adverse event profile reported following the first and second inoculation.
The early results did not reveal any serious adverse events, with the safety profile being similar to other vaccines developed using recombinant protein-technology.
In all dose arms, antibody titres were observed to be significantly greater following the boost vaccination.
The titres were up to 12-fold higher compared with those found in convalescent human specimens, as well as notably higher versus currently approved Covid-19 vaccines, Bavarian Nordic said.
Furthermore, the neutralisation titres were high against all SARS-CoV-2 variants of concern, including the Delta variant, which is known to be dominant.
The company anticipates final data from the trial in the second half of this year.
Bavarian Nordic president and CEO Paul Chaplin said: “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 favourable safety profile.
“These data are highly encouraging for our planned Phase II trial later this month, which is designed to evaluate the vaccine’s potential as a universal booster vaccine.”
The company intends to progress ABNCoV2 development and planned a Phase II trial in up to 210 participants.
Apart from validating Phase I data, the Phase II trial will assess the vaccine as a booster for people with prior Covid-19 infection or vaccination.
Subject to final approval from the Ethics Committee, the Phase II trial will be launched this month and carried out at two sites in Germany.
Bavarian Nordic is also working toward a Phase III trial of the vaccine next year.
ABNCoV2 was initially developed by AdaptVac using its capsid virus-like particle (cVLP) technology. Bavarian Nordic then licensed the worldwide commercialisation rights to the vaccine.