A 210-person Phase 2 clinical trial for the COVID-19 vaccine candidate, ABNCoV2, began this week to determine its potential as a booster vaccine for those who have either caught the disease previously or been otherwise vaccinated.
Licensed by Bavarian Nordic A/S and developed by AdaptVac, the vaccine uses capsid virus like particle technology for a highly immunogenic and antibody-spurring candidate. Early data from ABNCoV2’s first in-human trial showed a favorable safety profile and the ability to produce antibodies against most variants of SARS-CoV-2, including the Delta variant.
The Phase 2 trial will consist of healthy adult volunteers divided into two groups: 150 people who have either had COVID-19 or been vaccinated will receive a single 100 μg dose of ABNCoV2, while a second group of 60 non-vaccinated or infected subjects will receive two 100 μg doses of ABNCoV2, spaced 28 days apart. Researchers will be looking for the inducement of neutralizing antibody titers at two weeks from final vaccination. They will also assess safety and success against variant strains.
“We are pleased to advance our COVID-19 vaccine candidate into Phase 2 that we hope will confirm the high levels of neutralizing antibodies induced by ABNCoV2 that have already been shown in preclinical studies and a Phase 1 clinical trial,” Paul Chaplin, president and CEO of Bavarian Nordic, said. “There is a growing expectation that booster vaccinations will be required to manage the pandemic and to broaden the protection against emerging variants and we remain committed to the development of ABNCoV2, as we believe it has the potential to fulfil these requirements.”
Initial results of the trial are expected in the fourth quarter of 2021. Those with existing immunity to COVID-19 will continue to be studied for up to two years, though, to assess the lasting capabilities of the vaccine’s immune response.
While the Phase 2 trial is underway, Bavarian Nordic is beginning preparations for a Phase 3 trial as well, which is set to begin sometime next year if funding can be acquired.