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Bavarian Nordic initiates phase II clinical trial of ABNCoV2 a COVID-19 booster vaccine.

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Published:23rd Aug 2021
Bavarian Nordic A/S announced the initiation of a Phase II clinical trial of its COVID-19 vaccine candidate, ABNCoV2.

The trial will investigate the potential of ABNCoV2 as a booster vaccine for individuals with previous COVID-19 disease or vaccination.

The trial will enroll 150 healthy adults with existing immunity against SARS-CoV-2, acquired through previous disease or from prior immunization with approved COVID-19 vaccines, and will investigate the ability of a single vaccination with ABNCoV2 to boost existing levels of SARS-CoV-2 neutralizing antibodies across all groups. A second arm in the trial will enroll up to 60 healthy adults with no prior vaccination or disease who will receive two vaccinations for evaluation of neutralizing antibody levels from ABNCoV2 when used as a prime-boost vaccine. In both groups, neutralizing immune responses against circulating variants of SARS-CoV2 will be evaluated, as high levels of neutralizing antibodies have been reported as highly predictive of protection against COVID-19i.

Initial trial results are expected in the fourth quarter of 2021. Subjects in the group with existing immunity will remain on trial for up to two years to evaluate the durability of the immune response from the boost vaccination.

In parallel with the Phase II trial, Bavarian Nordic is preparing for a Phase III trial of ABNCoV2 in 2022, pending external funding.

About ABNCoV2 and the Phase II trial; ABNCoV2 is a next-generation COVID-19 vaccine candidate, initially developed by AdaptVac using their proprietary capsid virus like particle (cVLP) technology. Bavarian Nordic has licensed the global commercialization rights to the vaccine and has assumed the responsibility for further clinical development towards licensure. ABNCoV2 has shown to be highly immunogenic in relevant preclinical models inducing durable and highly protective response from a COVID-19 challenge. Initial data from the first-in-human trial of the vaccine have confirmed its ability to induce strong and broad antibody levels, superior to those of the current approved vaccines, while also providing a favorable safety profile. More importantly, the data confirms the potential of ABNCoV2 to induce neutralizing antibodies against circulating variants of SARS-CoV2, including the Delta variant.

Bavarian Nordic is sponsor of the Phase II trial, which is being conducted at two centers in Germany. The trial will enroll a total of up to 210 healthy adult volunteers into two groups: one group of 150 seropositive (prior disease or fully vaccinated) subjects will receive one 100 ug dose of ABNCoV2. Enrollment into this group will be stratified by seropositivity, i.e., previous COVID-19 disease or type of previous vaccination received, with at least 40 subjects enrolled in each stratification group. A second group of up to 60 seronegative subjects will receive two 100 ug doses of ABNCoV2, 28 days apart. The primary endpoint of the study is SARS-CoV-2 neutralizing antibody titers at 2 weeks after the last vaccination, i.e., after the second vaccination in initially seronegative subjects and after the single boost vaccination in seropositive subjects. Additional endpoints will, among others, focus on the safety of the vaccine and neutralizing antibody titers against variant strains circulating at the time of analysis at 2 weeks after last vaccination.

Condition: Coronavirus/COVID-19 Infection
Type: drug

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