The company noted that previously reported results from the study showed, 100ug ABNCoV2 in 103 seropositive people was able to show a strong boosting effect, increasing the existing levels of novel coronavirus neutralizing antibodies against the Wuhan variant and variants of concern (Alpha, Beta, Delta and Omicron) to levels reported to be highly efficacious (>90%) against SARS-CoV-2.
Bavarian added that a group of 41 people were followed for six months after vaccination. In this group, two people with confirmed COVID-19 were excluded from the immune analysis.
After six months of vaccination, neutralization titers were six times higher than pre-boost titers against Wuhan and nearly 10 times higher than the pre-boost titers for Omicron BA.1, the Danish company noted.
Bavarian added that this represented less than a 50% decline in peak neutralizing titers after six months and compared to the data published for mRNA vaccines, the antibody decay appeared less sharp, suggesting a potentially longer duration of protection across variants.
“These latest data further support the concept that ABNCoV2 could be a universal booster vaccine inducing strong and durable immune responses against all major variants of concern, including Omicron, without the need to modify the vaccine. We look forward to generating further data in the ongoing Phase 3 trial that will shortly open sites in Denmark,” said Bavarian President and CEO Paul Chaplin.
The company noted that in September it started a phase 3 trial to evaluate the non-inferiority of ABNCoV2 compared to Pfizer (PFE) and BioNTech’s (BNTX) Comirnaty. The study expects to enroll ~4,000 people who either previously completed primary vaccination or have already received one booster dose of a COVID vaccine.
Enrollment in the first group, which would include ~3K people, in the U.S. has already begun.